Primary HypertensionPhase 3NCT02817204
Effect of Aerobic EXercise on MiCroVAscular RarefacTION in Chinese Mild HyperteNsive Patients（EXCAVATION-CHN1）
A Phase 3 study testing Aerobic Exercise and Health Education in people with Primary Hypertension, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The purpose of this study is to determine the effect of aerobic exercise training on microcirculation rarefaction in Chinese young male primary hypertensive patients stage 1. Hypertension is one of the most common world-wide chronic diseases, and it is showing a growing younger trend, which with mild blood pressure… Read more about this study
- Who is it for?
- Ages 25 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Hypertension
- What is being tested?
- Aerobic Exercise and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- May 2016to 30 Jul 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 25 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects range from 18 to 40 years old.
- male
- Blood pressure is primary hypertension stage I(systolic blood pressure 140 to 159 mmHg and/or diastolic blood pressure 90 to 99 mmHg).
- Able to participate in exercise
- No regular physically active in the last 4 months
- Provide informed consent and willingness to cooperate with the study protocol
Who cannot join
- Less than 18 years old or above 40 years old
- Secondary hypertension.
- Females
- Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases
- Medical history of cardiovascular disease: acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular blockade, peripheral vascular disease or cerebrovascular accident
- Patients who are unfavorable of long-term follow-up or poor compliance
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 510000
Jun Tao, PhD, +8613922191609, taojungz123@163.com
Jianwen Liang, PhD
About this study
The purpose of this study is to determine the effect of aerobic exercise training on microcirculation rarefaction in Chinese young male primary hypertensive patients stage 1. Hypertension is one of the most common world-wide chronic diseases, and it is showing a growing younger trend, which with mild blood pressure elevated would not be diagnose in time until blood pressure raises up or symptoms show up (Mild blood pressure indicates blood pressures ranging from 140 to 159 mmHg systolic and/or 90 to 99 mmHg diastolic). However, cumulative evidences prove that microvascular rarefaction exist in hypertensive patients with even primary hypertension stage 1. Exercise prescription is gathering great importance in preventive health. Aerobic exercise, especially, has the potential to diminish blood pressure values, and aerobic exercise can promote angiogenesis in coronary heart disease. Notch signaling plays an important role in vascular formation and maintenance. However, there is no prospective, randomized, controlled, clinic trial to investigate the effect of exercise on microcirculation rarefaction in hypertension. In summary, investigators propose a hypothesis that aerobic exercise might not only have a blood pressure lowing effect but also improve microcirculation rarefaction in Chinese male adults with primary mild hypertension. For that, subjects will be enrolled for one pre-intervention cardiopulmonary exercise test (CPET) and then randomized in aerobic exercise intervention group and control group (only health education), the intervention will be carried out by Cycle Ergometer, the protocol consists of 3 sessions a day: 3 minutes Warm up, 45 minutes Resistance Exercise at 75% of HRmax; 10 minutes Recovery. Thus 58 minutes a day and 5 days a week (about 2000kcal) and 12 weeks in total. Prior and after all intervention sessions (12 weeks), nail fold capillary microscopy and retinal capillary Optical Coherence Tomography(OCT) angiography will be assessed, as well as 24h blood pressure monitoring, echocardiography, forearm blood flow and reactive hyperemia by venous occlusion plethysmography (FMD), PWV, central arterial pressure, RHI with Endopat, also the quantification of endothelial progenistor cells(EPCs) separated from peripheral blood.
Read the detailed description
Hypertension is one of the most common world-wide chronic diseases, and it is showing a growing younger trend, which with mild blood pressure elevated would not be diagnose in time until blood pressure raises up or symptoms show up (Mild blood pressure indicates blood pressures ranging from 140 to 159 mmHg systolic and/or 90 to 99 mmHg diastolic). However, cumulative evidences prove that microvascular rarefaction exist in hypertensive patients with even primary hypertension stage 1. Exercise prescription is gathering great importance in preventive health. Aerobic exercise, especially, has the potential to diminish blood pressure values, and aerobic exercise can promote angiogenesis in coronary heart disease. Notch signaling plays an important role in vascular formation and maintenance. However, there is no prospective, randomized, controlled, clinic trial to investigate the effect of exercise on microcirculation rarefaction in hypertension. In summary, investigators propose a hypothesis that aerobic exercise might not only have a blood pressure lowing effect but also improve microcirculation rarefaction in Chinese male adults with primary mild hypertension. For that, subjects will be enrolled for one pre-intervention cardiopulmonary exercise test (CPET) and then randomized in aerobic exercise intervention group and control group (only health education), the intervention will be carried out by Cycle Ergometer, the protocol consists of 3 sessions a day: 3 minutes Warm up, 45 minutes Resistance Exercise at 75% of HRmax; 10 minutes Recovery. Thus 58 minutes a day and 5 days a week (about 2000kcal) and 12 weeks in total. Prior and after all intervention sessions (12 weeks), nail fold capillary microscopy and retinal capillary Optical Coherence Tomography(OCT) angiography will be assessed, as well as 24h blood pressure monitoring, echocardiography, forearm blood Flow Mediated Diastolic function(FMD), Plus Wave Velocity(PWV), Reactive Hyperemia Index(RHI) with Endopat, also the quantification of endothelial progenistor cells(EPCs) separated from peripheral blood.
- Conditions
- Primary Hypertension
- Being tested
- Aerobic Exercise, Health Education
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Cycle ergometer exercise for 3 sessions a day (3 minutes Warm up,45 minutes Resistance Exercise at 75% of HRmax;10 minutes Recovery). 5 days a week(about 2000kcal) and continues 12 weeks
Health EducationBehavioural
Lower salt,fat and calorie diet,Recommendation of regular exercise,No smoking and alcohol
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise group | Experimental | Cardio Pulmonary Exercise Test(CPET) Cycle ergometer exercise for 3 sessions a day (3 minutes Warm up,45 minutes Resistance Exercise at 75% of HRmax;10 minutes Recovery). 5 days a week(about 2000kcal) and continues 12 weeks Receives: Behavioral: Aerobic Exercise; Behavioral: Health Education |
| Health Education Group | Other | Lower salt,fat and calorie diet,Recommendation of regular exercise,No smoking and alcohol Cardio Pulmonary Exercise Test(CPET) No Cycle ergometer exercise Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal capillary density with Quantitative Optical Coherence Tomography(OCT) angiography(OCT))
Measured: Change from Baseline retinal capillary density at 12 weeks
Nail fold capillary numbers per square millimeter( /mm²)
Measured: Change from Baseline nail fold capillary density at 12 weeks
Secondary outcomes (5)
24 hours ambulatory blood pressure (ABP) in millimeters of mercury(mmHg)
Measured: Change from Baseline Systolic Blood Pressure and Diastolic Blood Pressure at 12 weeks
Flow-mediated Dilation(FMD) in %
The percentage change in brachial artery diameter from baseline
Measured: Change from Baseline percentage at 12 weeks
Reactive Hyperemia Index(RHI) in the ratio of the average amplitude of the PAT signal
RHI was measured using the RH-PAT system (EndoPAT):A blood pressure cuff was placed on 1 upper arm with the contralateral arm serving as a control. A PAT probe was placed on 1 finger of each hand. After a 5-minute equilibration period, the cuff was inflated to 60 mm Hg above the systolic pressure or to 200 mm Hg for 5 minutes, then deflated to induce reactive hyperemia.
Measured: Change from Baseline ratio at 12 weeks
Abilities of tube formation of endothelial progenistor cells(EPCs) in tube numbers
Tube formation ability of EPCs was evaluated by counting tube numbers. Images of tube morphology were taken under the inverted phase contrast microscope.
Measured: Change from Baseline tube numbers at 12 weeks
Left Ventricular End-diastolic Volume (LVEDV) in milliliter(ml)
Measured: Change from Baseline volume at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startMay 2016
- Primary completion30 Jul 2017 (estimated)
- Study completion30 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary HypertensionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Tao, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Haipeng Xiao, PhD, Study chair, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817204
- Sponsor's protocol ID
- HVD001
- Status last verified
- Apr 2017
- First submitted
- 22 Jun 2016
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Liang J, Li Y, Chen L, Xia W, Wu G, Tong X, Su C, He J, Lin X, Tao J. Systemic microvascular rarefaction is correlated with dysfunction of late endothelial progenitor cells in mild hypertension: a substudy of EXCAVATION-CHN1. J Transl Med. 2019 Nov 12;17(1):368. doi: 10.1186/s12967-019-2108-8.
PubMed 31718666
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic EXercise on MiCroVAscular RarefacTION in Chinese Mild HyperteNsive Patients（EXCAVATION-CHN1）
- ClinicalTrials.gov ID
- NCT02817204
- Acronym / sponsor ID
- HVD001
- Conditions
- Primary Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 30 Jul 2017 (estimated)
- Study completion
- 30 Jul 2017 (estimated)
- First posted
- 29 Jun 2016 (estimated)
- 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.
The purpose of this study is to determine the effect of aerobic exercise training on microcirculation rarefaction in Chinese young male primary hypertensive patients stage 1. Hypertension is one of the most common world-wide chronic diseases, and it is showing a growing younger trend, which with mild blood pressure elevated would not be diagnose in time until blood pressure raises up or symptoms show up (Mild blood pressure indicates blood pressures ranging from 140 to 159 mmHg systolic and/or 90 to 99 mmHg diastolic). However, cumulative evidences prove that microvascular rarefaction exist in hypertensive patients with even primary hypertension stage 1. Exercise prescription is gathering great importance in preventive health. Aerobic exercise, especially, has the potential to diminish blood pressure values, and aerobic exercise can promote angiogenesis in coronary heart disease. Notch signaling plays an important role in vascular formation and maintenance. However, there is no prospective, randomized, controlled, clinic trial to investigate the effect of exercise on microcirculation rarefaction in hypertension. In summary, investigators propose a hypothesis that aerobic exercise might not only have a blood pressure lowing effect but also improve microcirculation rarefaction in Chinese male adults with primary mild hypertension. For that, subjects will be enrolled for one pre-intervention cardiopulmonary exercise test (CPET) and then randomized in aerobic exercise intervention group and control group (only health education), the intervention will be carried out by Cycle Ergometer, the protocol consists of 3 sessions a day: 3 minutes Warm up, 45 minutes Resistance Exercise at 75% of HRmax; 10 minutes Recovery. Thus 58 minutes a day and 5 days a week (about 2000kcal) and 12 weeks in total. Prior and after all intervention sessions (12 weeks), nail fold capillary microscopy and retinal capillary Optical Coherence Tomography(OCT) angiography will be assessed, as well as 24h blood pressure monitoring, echocardiography, forearm blood flow and reactive hyperemia by venous occlusion plethysmography (FMD), PWV, central arterial pressure, RHI with Endopat, also the quantification of endothelial progenistor cells(EPCs) separated from peripheral blood.
Detailed description
Hypertension is one of the most common world-wide chronic diseases, and it is showing a growing younger trend, which with mild blood pressure elevated would not be diagnose in time until blood pressure raises up or symptoms show up (Mild blood pressure indicates blood pressures ranging from 140 to 159 mmHg systolic and/or 90 to 99 mmHg diastolic). However, cumulative evidences prove that microvascular rarefaction exist in hypertensive patients with even primary hypertension stage 1. Exercise prescription is gathering great importance in preventive health. Aerobic exercise, especially, has the potential to diminish blood pressure values, and aerobic exercise can promote angiogenesis in coronary heart disease. Notch signaling plays an important role in vascular formation and maintenance. However, there is no prospective, randomized, controlled, clinic trial to investigate the effect of exercise on microcirculation rarefaction in hypertension. In summary, investigators propose a hypothesis that aerobic exercise might not only have a blood pressure lowing effect but also improve microcirculation rarefaction in Chinese male adults with primary mild hypertension. For that, subjects will be enrolled for one pre-intervention cardiopulmonary exercise test (CPET) and then randomized in aerobic exercise intervention group and control group (only health education), the intervention will be carried out by Cycle Ergometer, the protocol consists of 3 sessions a day: 3 minutes Warm up, 45 minutes Resistance Exercise at 75% of HRmax; 10 minutes Recovery. Thus 58 minutes a day and 5 days a week (about 2000kcal) and 12 weeks in total. Prior and after all intervention sessions (12 weeks), nail fold capillary microscopy and retinal capillary Optical Coherence Tomography(OCT) angiography will be assessed, as well as 24h blood pressure monitoring, echocardiography, forearm blood Flow Mediated Diastolic function(FMD), Plus Wave Velocity(PWV), Reactive Hyperemia Index(RHI) with Endopat, also the quantification of endothelial progenistor cells(EPCs) separated from peripheral blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise group | Experimental | Behavioral: Aerobic Exercise, Behavioral: Health EducationCardio Pulmonary Exercise Test(CPET) Cycle ergometer exercise for 3 sessions a day (3 minutes Warm up,45 minutes Resistance Exercise at 75% of HRmax;10 minutes Recovery). 5 days a week(about 2000kcal) and continues 12 weeks |
| Health Education Group | Other | Behavioral: Health EducationLower salt,fat and calorie diet,Recommendation of regular exercise,No smoking and alcohol Cardio Pulmonary Exercise Test(CPET) No Cycle ergometer exercise |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects range from 18 to 40 years old.
- male
- Blood pressure is primary hypertension stage I(systolic blood pressure 140 to 159 mmHg and/or diastolic blood pressure 90 to 99 mmHg).
- Able to participate in exercise
- No regular physically active in the last 4 months
Key exclusion criteria (6 listed)
- Less than 18 years old or above 40 years old
- Secondary hypertension.
- Females
- Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases
- Medical history of cardiovascular disease: acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular blockade, peripheral vascular disease or cerebrovascular accident
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 |
|---|---|---|
| Aerobic ExerciseCycle ergometer exercise for 3 sessions a day (3 minutes Warm up,45 minutes Resistance Exercise at 75% of HRmax;10 minutes Recovery). 5 days a week(about 2000kcal) and continues 12 weeks | Behavioural | Aerobic Exercise group |
| Health EducationLower salt,fat and calorie diet,Recommendation of regular exercise,No smoking and alcohol | Behavioural | Aerobic Exercise group, Health Education Group |
Primary outcome
Retinal capillary density with Quantitative Optical Coherence Tomography(OCT) angiography(OCT))
Time frame: Change from Baseline retinal capillary density at 12 weeks
Nail fold capillary numbers per square millimeter( /mm²)
Time frame: Change from Baseline nail fold capillary density at 12 weeks
5 secondary outcomes
24 hours ambulatory blood pressure (ABP) in millimeters of mercury(mmHg)
Time frame: Change from Baseline Systolic Blood Pressure and Diastolic Blood Pressure at 12 weeks
Flow-mediated Dilation(FMD) in %
Time frame: Change from Baseline percentage at 12 weeks
Reactive Hyperemia Index(RHI) in the ratio of the average amplitude of the PAT signal
Time frame: Change from Baseline ratio at 12 weeks
Abilities of tube formation of endothelial progenistor cells(EPCs) in tube numbers
Time frame: Change from Baseline tube numbers at 12 weeks
Left Ventricular End-diastolic Volume (LVEDV) in milliliter(ml)
Time frame: Change from Baseline volume at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Derived from this study: PubMed 31718666Liang J, Li Y, Chen L, Xia W, Wu G, Tong X, Su C, He J, Lin X, Tao J. Systemic microvascular rarefaction is correlated with dysfunction of late endothelial progenitor cells in mild hypertension: a substudy of EXCAVATION-CHN1. J Transl Med. 2019 Nov 12;17(1):368. doi: 10.1186/s12967-019-2108-8.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Haipeng Xiao, PhD study chair
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aerobic Exercise and Health Education in people with Primary Hypertension, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site 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 6 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: status not confirmed, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Tao, PhD (+8613922191609, taojungz123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal capillary density with Quantitative Optical Coherence Tomography(OCT) angiography(OCT)) (time frame: Change from Baseline retinal capillary density at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02817204, which also lists 1 linked publication.
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 25 Apr 2017.