HypertensionNCT07831551
EECP for Erectile Dysfunction in Elderly Hypertensive Patients
A study testing Enhanced External Counterpulsation in people with Hypertension and Erectile Dysfunction, run by Qilu Hospital of Shandong University at 2 sites in China.
Trial summary
Hypertension and erectile dysfunction are common health problems in older men and may share vascular dysfunction as an underlying mechanism. Enhanced external counterpulsation (EECP) is a noninvasive treatment in which inflatable cuffs placed around the legs and buttocks are inflated and deflated in synchronization… Read more about this study
- Who is it for?
- Ages 60 to 75 years, men only
- Conditions the study is for
- Hypertension, Erectile Dysfunction
- What is being tested?
- Enhanced External Counterpulsation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male participants aged 60 to 75 years with a stable sexual partner.
- Diagnosis of hypertension, defined as one of the following: office blood pressure ≥140/90 mmHg measured on three separate days without antihypertensive treatment; mean home blood pressure ≥135/85 mmHg measured over 5 to 7 consecutive days; or 24-hour ambulatory blood pressure ≥130/80 mmHg, daytime blood pressure ≥135/85 mmHg, or nighttime blood pressure ≥120/70 mmHg. Participants with a previous diagnosis of hypertension who are currently receiving antihypertensive treatment remain eligible even if their current blood pressure is below these thresholds.
- Diagnosis of erectile dysfunction, defined as a 5-item International Index of Erectile Function (IIEF-5) score ≤21 with a duration of at least 3 months.
- Stable lifestyle, a stable female sexual partner, and willingness to attempt sexual intercourse with that partner during the study.
- No treatment with phosphodiesterase type 5 inhibitors, hormones, health supplements, or other treatments intended to improve erectile function, including traditional Chinese medicines, within 3 months before enrollment.
- Voluntary participation and ability to read, understand, and provide written informed consent.
Who cannot join
- Severe cardiac disease, including New York Heart Association class IV heart failure, left ventricular ejection fraction <30%, malignant arrhythmia, or other clinically significant cardiac conditions.
- Uncontrolled hypertension (>180/110 mmHg) or secondary hypertension.
- Diabetes mellitus.
- Current use of other medications that may significantly affect blood pressure, such as glucocorticoids.
- A condition associated with an increased risk of priapism, such as sickle cell anemia or leukemia.
- Peptic ulcer disease, a bleeding disorder, visual abnormality, or hearing impairment.
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- Malignant tumor or another severe primary disease involving the heart, liver, kidneys, hematopoietic system, or another major organ or system.
- Neurological or psychiatric disease that prevents cooperation with study procedures, or unwillingness to cooperate.
- History of alcohol or drug abuse.
- Participation in another clinical trial within the previous 3 months.
- A contraindication to enhanced external counterpulsation, including severe aortic regurgitation, aortic aneurysm, active thrombophlebitis, or lower-extremity deep vein thrombosis.
- A clinically significant penile anatomical or structural abnormality as determined by the investigator, including micropenis, penile curvature, or fibrosis of the corpora cavernosa.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Lin Shen, MD, +8618560082257, slmm321@126.com
Shihao Sun, +86-13853993929, sunshihao131@163.com
The Seventh Affiliated Hospital (Shenzhen), Sun Yat-sen University
Shenzhen, Guangdong, 518107
Xujun Xuan, MD, +86-18802006303, xxjun777@163.com
About this study
Official title: Efficacy and Safety of Enhanced External Counterpulsation in Elderly Hypertensive Patients With Erectile Dysfunction: A Randomized Controlled Trial
Hypertension and erectile dysfunction are common health problems in older men and may share vascular dysfunction as an underlying mechanism. Enhanced external counterpulsation (EECP) is a noninvasive treatment in which inflatable cuffs placed around the legs and buttocks are inflated and deflated in synchronization with the heartbeat to improve blood flow.
The purpose of this randomized controlled trial is to determine whether EECP, when added to usual antihypertensive treatment, improves blood pressure and is safe in older men with both hypertension and erectile dysfunction. The study will also evaluate whether EECP improves erectile function and other measures related to vascular function, circulation, quality of life, sleep, and psychological well-being.
Read more
A total of 106 men aged 60 to 75 years will be enrolled at two study centers. Participants will be randomly assigned in a 1:1 ratio to receive either active EECP or sham EECP in addition to their usual antihypertensive treatment. Active EECP will be administered for 1 hour per session, once daily, for 35 sessions over 5 weeks. Sham EECP will be administered using the same device and treatment schedule but at a low cuff pressure that is not expected to produce effective counterpulsation. Participants will not know which treatment they receive.
The main study outcome is the change from baseline to the end of the treatment period in average office blood pressure, calculated from three consecutive blood pressure measurements obtained at the study visit. Additional assessments will include office blood pressure during follow-up, 24-hour ambulatory blood pressure monitoring, erectile function, vascular function, hemodynamic measures, quality of life, and adverse events.
Participants will be assessed at baseline, after 20 treatment sessions, at the end of treatment, and at 1, 3, and 6 months after treatment.
Read the detailed description
This is a two-center, participant-masked, randomized, sham-controlled clinical trial designed to evaluate the efficacy and safety of enhanced external counterpulsation (EECP) in older men with hypertension and erectile dysfunction.
Hypertension and erectile dysfunction may share vascular endothelial dysfunction as an underlying pathophysiological mechanism. EECP is a noninvasive external counterpulsation treatment that may improve systemic blood flow, tissue perfusion, and vascular endothelial function. This study will primarily evaluate the effect of EECP on blood pressure and will also explore its effects on erectile function and vascular function.
A total of 106 male participants aged 60 to 75 years will be enrolled. Eligible participants must have hypertension and erectile dysfunction, defined as a 5-item International Index of Erectile Function (IIEF-5) score of 21 or lower with a duration of at least 3 months.
Participants will be randomly assigned in a 1:1 ratio to the active EECP group or the sham EECP group. Stratified block randomization will be used, with study center as the stratification factor and a block size of 4. Participants will be masked to treatment assignment. Both groups will continue their usual antihypertensive treatment, and antihypertensive medication regimens will be kept stable whenever clinically feasible during the study.
Participants assigned to the active EECP group will receive electrocardiogram-triggered sequential cuff inflation at a pressure of 250 to 275 mmHg. Treatment will be administered for 1 hour per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks.
Participants assigned to the sham EECP group will undergo the same treatment procedures using the same device and treatment schedule, but the cuff pressure will be set at 70 mmHg. This pressure is intended to preserve a treatment experience similar to active EECP without producing effective counterpulsation.
The primary objective is to compare the change from baseline to the end of the treatment period in average office blood pressure between the active EECP and sham EECP groups. Average office blood pressure will be calculated from three consecutive blood pressure measurements obtained at the study visit.
Secondary and exploratory assessments will include immediate changes in blood pressure and heart rate before, during, and after individual treatment sessions; changes in office blood pressure after 20 treatment sessions and during follow-up; and parameters obtained from 24-hour ambulatory blood pressure monitoring.
Erectile function will be assessed using the IIEF-5, Sexual Encounter Profile questions 2 and 3, the Global Assessment Question, the Self-Esteem and Relationship questionnaire, and the Erectile Hardness Score.
Other assessments will include serum nitric oxide and vascular endothelial growth factor levels; vascular endothelial function; penile arterial blood-flow parameters; systemic hemodynamic parameters; pulse wave velocity; heart rate variability; psychological status; sleep quality; quality of life; and nocturia.
Safety will be evaluated by recording the occurrence, severity, and relationship to treatment of adverse events, including skin injury, arrhythmia, and priapism.
Study assessments will be conducted at baseline, after 20 EECP sessions, at completion of treatment, and at 1, 3, and 6 months after treatment. The study hypothesis is that active EECP will produce a greater improvement in blood pressure than sham EECP and may also improve erectile function, potentially through beneficial effects on vascular endothelial function.
- Conditions
- Hypertension, Erectile Dysfunction
- Being tested
- Enhanced External Counterpulsation, Sham Enhanced External Counterpulsation
- Keywords
- Enhanced External Counterpulsation, EECP, Ambulatory Blood Pressure Monitoring, Vascular Endothelial Function, Older Men
- Medical subject headings
- Hypertension, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced External CounterpulsationDevice
Also called EECP, P-ECP/TI
Active enhanced external counterpulsation (EECP) will be delivered using an electrocardiogram-triggered EECP system (model P-ECP/TI). Pneumatic cuffs placed around the calves, thighs, and buttocks will inflate sequentially during cardiac diastole and deflate before systole. The cuff pressure will be set at 250 to 275 mmHg. Treatment will be administered for 60 minutes per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks. Participants will continue their usual antihypertensive treatment, which will be kept stable whenever clinically feasible during the study.
Sham Enhanced External CounterpulsationDevice
Also called Sham EECP
Sham enhanced external counterpulsation will be administered using the same EECP device, cuff placement, electrocardiogram triggering, procedures, session duration, frequency, and treatment period as active EECP. The cuff pressure will be set at 70 mmHg, which is intended to provide a treatment experience similar to active EECP without producing effective counterpulsation. Treatment will be administered for 60 minutes per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks. Participants will continue their usual antihypertensive treatment, which will be kept stable whenever clinically feasible during the study.
| Study group | Role | What they receive |
|---|---|---|
| Active EECP | Experimental | Participants will continue their usual antihypertensive treatment and receive active enhanced external counterpulsation (EECP). Active EECP will be delivered using an electrocardiogram-triggered EECP device with sequential cuff inflation at a pressure of 250 to 275 mmHg. Treatment will be administered for 1 hour per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks. Receives: Device: Enhanced External Counterpulsation |
| Sham EECP | Sham comparator | Participants will continue their usual antihypertensive treatment and receive sham enhanced external counterpulsation using the same device, cuff placement, procedures, and treatment schedule as the active intervention. The cuff pressure will be set at 70 mmHg, which is not expected to produce effective counterpulsation. Treatment will be administered for 1 hour per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks. Receives: Device: Sham Enhanced External Counterpulsation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Office Systolic Blood Pressure at the End of Treatment
Office systolic blood pressure will be measured three consecutive times at the study visit according to the standardized blood pressure measurement procedure. The arithmetic mean of the three measurements will be used as the mean office systolic blood pressure. The outcome will be calculated as the mean office systolic blood pressure at the end of the 5-week treatment period minus the corresponding baseline value and will be reported in mmHg.
Measured: Baseline and Day 35 (end of the 5-week treatment period)
Secondary outcomes (47)
Change From Baseline in Mean Office Diastolic Blood Pressure at the End of Treatment
Office diastolic blood pressure will be measured three consecutive times at the study visit. The arithmetic mean of the three measurements will be used. The outcome will be calculated as the mean office diastolic blood pressure at the end of the 5-week treatment period minus the corresponding baseline value and will be reported in mmHg.
Measured: Baseline and Week 5 (end of the treatment period)
Mean Within-Session Change in Supine Systolic Blood Pressure
Supine systolic blood pressure will be measured 3 minutes before each treatment session, at 30 minutes during the session, and 3 minutes after the session. Changes from the pre-session measurement to the during-session and post-session measurements will be calculated and reported in mmHg.
Measured: At each treatment session from Day 1 through Week 5: 3 minutes before treatment, 30 minutes after treatment initiation, and 3 minutes after treatment
Mean Within-Session Change in Supine Diastolic Blood Pressure
Supine diastolic blood pressure will be measured 3 minutes before each treatment session, at 30 minutes during the session, and 3 minutes after the session. Changes from the pre-session measurement to the during-session and post-session measurements will be calculated and reported in mmHg.
Measured: At each treatment session from Day 1 through Week 5: 3 minutes before treatment, 30 minutes after treatment initiation, and 3 minutes after treatment
Mean Within-Session Change in Supine Heart Rate
Supine heart rate will be measured 3 minutes before each treatment session, at 30 minutes during the session, and 3 minutes after the session. Changes from the pre-session measurement to the during-session and post-session measurements will be calculated and reported in beats per minute.
Measured: At each treatment session from Day 1 through Week 5: 3 minutes before treatment, 30 minutes after treatment initiation, and 3 minutes after treatment
Change From Baseline in Mean Office Systolic Blood Pressure at Follow-up Assessments
Office systolic blood pressure will be measured three consecutive times at each study visit, and the arithmetic mean will be used. Change from baseline will be calculated separately at each prespecified post-baseline assessment and reported in mmHg.
Measured: Baseline; Week 3 (after 20 treatment sessions); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Mean Office Diastolic Blood Pressure at Follow-up Assessments
Office diastolic blood pressure will be measured three consecutive times at each study visit, and the arithmetic mean will be used. Change from baseline will be calculated separately at each prespecified post-baseline assessment and reported in mmHg.
Measured: Baseline; Week 3 (after 20 treatment sessions); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in 24-Hour Mean Systolic Blood Pressure
Twenty-four-hour mean systolic blood pressure will be measured using ambulatory blood pressure monitoring. Change from baseline will be calculated separately at each prespecified post-baseline assessment and reported in mmHg.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in 24-Hour Mean Diastolic Blood Pressure
Twenty-four-hour mean diastolic blood pressure will be measured using ambulatory blood pressure monitoring. Change from baseline will be calculated separately at each prespecified post-baseline assessment and reported in mmHg.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in the 5-Item International Index of Erectile Function Total Score
Erectile function will be assessed using the 5-item International Index of Erectile Function. The total score will be calculated according to the prespecified scoring method. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Percentage of Participants Answering Yes to Sexual Encounter Profile Question 2
Sexual Encounter Profile Question 2 asks whether the participant was able to insert the penis into the partner's vagina. The percentage of participants answering Yes will be calculated at each prespecified assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Percentage of Participants Answering Yes to Sexual Encounter Profile Question 3
Sexual Encounter Profile Question 3 asks whether the participant's erection lasted long enough for successful intercourse. The percentage of participants answering Yes will be calculated at each prespecified assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Percentage of Participants Answering Yes to the Global Assessment Question
Participants will answer whether the treatment received during the study improved their erections. The percentage of participants answering Yes will be calculated at each prespecified assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in the Self-Esteem and Relationship Questionnaire Score
Self-esteem and sexual relationship outcomes will be assessed using the Self-Esteem and Relationship questionnaire. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Erectile Hardness Score
Erection hardness will be assessed using the Erectile Hardness Score, ranging from Grade 1 to Grade 4, with higher grades indicating greater erection hardness. Change from baseline will be evaluated at each prespecified assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Serum Nitric Oxide Level
The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 5 (end of the treatment period); and Month 3 after the end of treatment
Change From Baseline in Serum Vascular Endothelial Growth Factor Level
The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 5 (end of the treatment period); and Month 3 after the end of treatment
Change From Baseline in Brachial Artery Flow-Mediated Dilation
The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Reactive Hyperemia Index
The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Penile Artery Resistance Index
The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Penile Artery Peak Systolic Velocity
The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Cardiac Index
The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Cardiac Output
The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Stroke Volume
The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Stroke Volume Index
The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Mean Arterial Pressure
The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in SSVRI
The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Left Ventricular Stroke Work Index
The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Systemic Vascular Resistance Index
The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Ejection Phase Contractility Index
The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Inotropic State Index
The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Systemic Vascular Resistance
The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Total Vascular Resistance
The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Mean Heart Rate
The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Pulse Wave Velocity
The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Hamilton Anxiety Rating Scale Total Score
Anxiety severity will be assessed using the prespecified validated version of the Hamilton Anxiety Rating Scale (HAM-A). The total score will be calculated according to the standard scoring method, with higher scores indicating greater anxiety severity. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in [Full Name of Depression Scale] Total Score
Depressive symptoms will be assessed using the prespecified validated version of the [full name and abbreviation of the depression scale]. The total score ranges from [minimum score] to [maximum score], with higher scores indicating [greater or lower] depressive symptom severity. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Pittsburgh Sleep Quality Index Global Score
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Change from baseline will be calculated separately at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in 36-Item Short Form Health Survey Domain Scores
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). Eight domain scores will be calculated according to the standard scoring algorithm and transformed to a scale from 0 to 100, with higher scores indicating better health status. Change from baseline will be calculated separately for each domain at each post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in the Standard Deviation of Normal-to-Normal Intervals
Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. The standard deviation of all normal-to-normal intervals (SDNN) will be calculated and reported in milliseconds. Change from baseline will be calculated separately at each prespecified post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in the Root Mean Square of Successive Normal-to-Normal Interval Differences
Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. The root mean square of successive normal-to-normal interval differences (RMSSD) will be calculated and reported in milliseconds. Change from baseline will be calculated separately at each prespecified post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in the Percentage of Successive Normal-to-Normal Intervals Differing by More Than 50 Milliseconds
Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. The percentage of successive normal-to-normal intervals differing by more than 50 milliseconds (pNN50) will be calculated and reported as a percentage. Change from baseline will be calculated separately at each prespecified post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Low-Frequency Power
Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. Low-frequency power will be calculated using the prespecified frequency-domain analysis method and reported in square milliseconds. Change from baseline will be calculated separately at each prespecified post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in High-Frequency Power
Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. High-frequency power will be calculated using the prespecified frequency-domain analysis method and reported in square milliseconds. Change from baseline will be calculated separately at each prespecified post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Very-Low-Frequency Power
Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. Very-low-frequency power will be calculated using the prespecified frequency-domain analysis method and reported in square milliseconds. Change from baseline will be calculated separately at each prespecified post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Total Heart Rate Variability Power
Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. Total heart rate variability power will be calculated using the prespecified frequency-domain analysis method and reported in square milliseconds. Change from baseline will be calculated separately at each prespecified post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in the Number of Nocturia Episodes per Night
The number of nocturia episodes will be recorded based on the participant's report of the number of times the participant wakes from sleep to urinate during the usual nighttime sleep period. Change from baseline will be calculated separately at each prespecified post-baseline assessment.
Measured: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Number of Participants With Adverse Events
All adverse events occurring after informed consent will be recorded and assessed for severity and relationship to the study intervention. Events of special interest include skin injury, arrhythmia, and priapism. The number and percentage of participants experiencing one or more adverse events will be summarized by study arm.
Measured: From informed consent through Month 6 after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831551
- Sponsor's protocol ID
- KYLL-2026-05-021-1
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with external researchers because the study includes sensitive personal health and sexual-function information and is subject to institutional ethics, privacy, and data-protection requirements. Study results will be reported only in aggregate form through scientific publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Enhanced External Counterpulsation in Elderly Hypertensive Patients With Erectile Dysfunction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07831551
- Acronym / sponsor ID
- KYLL-2026-05-021-1
- Conditions
- Hypertension, Erectile Dysfunction
- Keywords
- Enhanced External Counterpulsation, EECP, Ambulatory Blood Pressure Monitoring, Vascular Endothelial Function, Older Men
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypertension and erectile dysfunction are common health problems in older men and may share vascular dysfunction as an underlying mechanism. Enhanced external counterpulsation (EECP) is a noninvasive treatment in which inflatable cuffs placed around the legs and buttocks are inflated and deflated in synchronization with the heartbeat to improve blood flow.
The purpose of this randomized controlled trial is to determine whether EECP, when added to usual antihypertensive treatment, improves blood pressure and is safe in older men with both hypertension and erectile dysfunction. The study will also evaluate whether EECP improves erectile function and other measures related to vascular function, circulation, quality of life, sleep, and psychological well-being.
A total of 106 men aged 60 to 75 years will be enrolled at two study centers. Participants will be randomly assigned in a 1:1 ratio to receive either active EECP or sham EECP in addition to their usual antihypertensive treatment. Active EECP will be administered for 1 hour per session, once daily, for 35 sessions over 5 weeks. Sham EECP will be administered using the same device and treatment schedule but at a low cuff pressure that is not expected to produce effective counterpulsation. Participants will not know which treatment they receive.
The main study outcome is the change from baseline to the end of the treatment period in average office blood pressure, calculated from three consecutive blood pressure measurements obtained at the study visit. Additional assessments will include office blood pressure during follow-up, 24-hour ambulatory blood pressure monitoring, erectile function, vascular function, hemodynamic measures, quality of life, and adverse events.
Participants will be assessed at baseline, after 20 treatment sessions, at the end of treatment, and at 1, 3, and 6 months after treatment.
Detailed description
This is a two-center, participant-masked, randomized, sham-controlled clinical trial designed to evaluate the efficacy and safety of enhanced external counterpulsation (EECP) in older men with hypertension and erectile dysfunction.
Hypertension and erectile dysfunction may share vascular endothelial dysfunction as an underlying pathophysiological mechanism. EECP is a noninvasive external counterpulsation treatment that may improve systemic blood flow, tissue perfusion, and vascular endothelial function. This study will primarily evaluate the effect of EECP on blood pressure and will also explore its effects on erectile function and vascular function.
A total of 106 male participants aged 60 to 75 years will be enrolled. Eligible participants must have hypertension and erectile dysfunction, defined as a 5-item International Index of Erectile Function (IIEF-5) score of 21 or lower with a duration of at least 3 months.
Participants will be randomly assigned in a 1:1 ratio to the active EECP group or the sham EECP group. Stratified block randomization will be used, with study center as the stratification factor and a block size of 4. Participants will be masked to treatment assignment. Both groups will continue their usual antihypertensive treatment, and antihypertensive medication regimens will be kept stable whenever clinically feasible during the study.
Participants assigned to the active EECP group will receive electrocardiogram-triggered sequential cuff inflation at a pressure of 250 to 275 mmHg. Treatment will be administered for 1 hour per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks.
Participants assigned to the sham EECP group will undergo the same treatment procedures using the same device and treatment schedule, but the cuff pressure will be set at 70 mmHg. This pressure is intended to preserve a treatment experience similar to active EECP without producing effective counterpulsation.
The primary objective is to compare the change from baseline to the end of the treatment period in average office blood pressure between the active EECP and sham EECP groups. Average office blood pressure will be calculated from three consecutive blood pressure measurements obtained at the study visit.
Secondary and exploratory assessments will include immediate changes in blood pressure and heart rate before, during, and after individual treatment sessions; changes in office blood pressure after 20 treatment sessions and during follow-up; and parameters obtained from 24-hour ambulatory blood pressure monitoring.
Erectile function will be assessed using the IIEF-5, Sexual Encounter Profile questions 2 and 3, the Global Assessment Question, the Self-Esteem and Relationship questionnaire, and the Erectile Hardness Score.
Other assessments will include serum nitric oxide and vascular endothelial growth factor levels; vascular endothelial function; penile arterial blood-flow parameters; systemic hemodynamic parameters; pulse wave velocity; heart rate variability; psychological status; sleep quality; quality of life; and nocturia.
Safety will be evaluated by recording the occurrence, severity, and relationship to treatment of adverse events, including skin injury, arrhythmia, and priapism.
Study assessments will be conducted at baseline, after 20 EECP sessions, at completion of treatment, and at 1, 3, and 6 months after treatment. The study hypothesis is that active EECP will produce a greater improvement in blood pressure than sham EECP and may also improve erectile function, potentially through beneficial effects on vascular endothelial function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active EECP | Experimental | Device: Enhanced External CounterpulsationParticipants will continue their usual antihypertensive treatment and receive active enhanced external counterpulsation (EECP). Active EECP will be delivered using an electrocardiogram-triggered EECP device with sequential cuff inflation at a pressure of 250 to 275 mmHg. Treatment will be administered for 1 hour per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks. |
| Sham EECP | Sham comparator | Device: Sham Enhanced External CounterpulsationParticipants will continue their usual antihypertensive treatment and receive sham enhanced external counterpulsation using the same device, cuff placement, procedures, and treatment schedule as the active intervention. The cuff pressure will be set at 70 mmHg, which is not expected to produce effective counterpulsation. Treatment will be administered for 1 hour per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male participants aged 60 to 75 years with a stable sexual partner.
- Diagnosis of hypertension, defined as one of the following: office blood pressure ≥140/90 mmHg measured on three separate days without antihypertensive treatment; mean home blood pressure ≥135/85 mmHg measured over 5 to 7 consecutive days; or 24-hour ambulatory blood pressure ≥130/80 mmHg, daytime blood pressure ≥135/85 mmHg, or nighttime blood pressure ≥120/70 mmHg. Participants with a previous diagnosis of hypertension who are currently receiving antihypertensive treatment remain eligible even if their current blood pressure is below these thresholds.
- Diagnosis of erectile dysfunction, defined as a 5-item International Index of Erectile Function (IIEF-5) score ≤21 with a duration of at least 3 months.
- Stable lifestyle, a stable female sexual partner, and willingness to attempt sexual intercourse with that partner during the study.
- No treatment with phosphodiesterase type 5 inhibitors, hormones, health supplements, or other treatments intended to improve erectile function, including traditional Chinese medicines, within 3 months before enrollment.
Key exclusion criteria (12 listed)
- Severe cardiac disease, including New York Heart Association class IV heart failure, left ventricular ejection fraction <30%, malignant arrhythmia, or other clinically significant cardiac conditions.
- Uncontrolled hypertension (>180/110 mmHg) or secondary hypertension.
- Diabetes mellitus.
- Current use of other medications that may significantly affect blood pressure, such as glucocorticoids.
- A condition associated with an increased risk of priapism, such as sickle cell anemia or leukemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced External CounterpulsationAlso: EECP, P-ECP/TIActive enhanced external counterpulsation (EECP) will be delivered using an electrocardiogram-triggered EECP system (model P-ECP/TI). Pneumatic cuffs placed around the calves, thighs, and buttocks will inflate sequentially during cardiac diastole and deflate before systole. The cuff pressure will be set at 250 to 275 mmHg. Treatment will be administered for 60 minutes per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks. Participants will continue their usual antihypertensive treatment, which will be kept stable whenever clinically feasible during the study. | Device | Active EECP |
| Sham Enhanced External CounterpulsationAlso: Sham EECPSham enhanced external counterpulsation will be administered using the same EECP device, cuff placement, electrocardiogram triggering, procedures, session duration, frequency, and treatment period as active EECP. The cuff pressure will be set at 70 mmHg, which is intended to provide a treatment experience similar to active EECP without producing effective counterpulsation. Treatment will be administered for 60 minutes per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks. Participants will continue their usual antihypertensive treatment, which will be kept stable whenever clinically feasible during the study. | Device | Sham EECP |
Primary outcome
Change From Baseline in Mean Office Systolic Blood Pressure at the End of Treatment
Time frame: Baseline and Day 35 (end of the 5-week treatment period)
Office systolic blood pressure will be measured three consecutive times at the study visit according to the standardized blood pressure measurement procedure. The arithmetic mean of the three measurements will be used as the mean office systolic blood pressure. The outcome will be calculated as the mean office systolic blood pressure at the end of the 5-week treatment period minus the corresponding baseline value and will be reported in mmHg.
47 secondary outcomes
Change From Baseline in Mean Office Diastolic Blood Pressure at the End of Treatment
Time frame: Baseline and Week 5 (end of the treatment period)
Mean Within-Session Change in Supine Systolic Blood Pressure
Time frame: At each treatment session from Day 1 through Week 5: 3 minutes before treatment, 30 minutes after treatment initiation, and 3 minutes after treatment
Mean Within-Session Change in Supine Diastolic Blood Pressure
Time frame: At each treatment session from Day 1 through Week 5: 3 minutes before treatment, 30 minutes after treatment initiation, and 3 minutes after treatment
Mean Within-Session Change in Supine Heart Rate
Time frame: At each treatment session from Day 1 through Week 5: 3 minutes before treatment, 30 minutes after treatment initiation, and 3 minutes after treatment
Change From Baseline in Mean Office Systolic Blood Pressure at Follow-up Assessments
Time frame: Baseline; Week 3 (after 20 treatment sessions); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Mean Office Diastolic Blood Pressure at Follow-up Assessments
Time frame: Baseline; Week 3 (after 20 treatment sessions); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in 24-Hour Mean Systolic Blood Pressure
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in 24-Hour Mean Diastolic Blood Pressure
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in the 5-Item International Index of Erectile Function Total Score
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Percentage of Participants Answering Yes to Sexual Encounter Profile Question 2
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Percentage of Participants Answering Yes to Sexual Encounter Profile Question 3
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Percentage of Participants Answering Yes to the Global Assessment Question
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in the Self-Esteem and Relationship Questionnaire Score
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Erectile Hardness Score
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Serum Nitric Oxide Level
Time frame: Baseline; Week 5 (end of the treatment period); and Month 3 after the end of treatment
Change From Baseline in Serum Vascular Endothelial Growth Factor Level
Time frame: Baseline; Week 5 (end of the treatment period); and Month 3 after the end of treatment
Change From Baseline in Brachial Artery Flow-Mediated Dilation
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Reactive Hyperemia Index
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Penile Artery Resistance Index
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Penile Artery Peak Systolic Velocity
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Cardiac Index
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Cardiac Output
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Stroke Volume
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Stroke Volume Index
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Mean Arterial Pressure
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in SSVRI
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Left Ventricular Stroke Work Index
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Systemic Vascular Resistance Index
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Ejection Phase Contractility Index
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Inotropic State Index
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Systemic Vascular Resistance
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Total Vascular Resistance
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Mean Heart Rate
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Pulse Wave Velocity
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Hamilton Anxiety Rating Scale Total Score
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in [Full Name of Depression Scale] Total Score
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Pittsburgh Sleep Quality Index Global Score
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in 36-Item Short Form Health Survey Domain Scores
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in the Standard Deviation of Normal-to-Normal Intervals
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in the Root Mean Square of Successive Normal-to-Normal Interval Differences
Time frame: Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with external researchers because the study includes sensitive personal health and sexual-function information and is subject to institutional ethics, privacy, and data-protection requirements. Study results will be reported only in aggregate form through scientific publications and presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced External Counterpulsation in people with Hypertension and Erectile Dysfunction, run by Qilu Hospital of Shandong University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Shen, MD (+8618560082257, slmm321@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mean Office Systolic Blood Pressure at the End of Treatment (time frame: Baseline and Day 35 (end of the 5-week treatment period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.