HemodialysisEECP in HDNCT06608953
A Prospective Randomized Controlled Trial of Effect of Enhanced External Counter Pulsation to Arterial Stiffness in Chronic Hemodialysis Patient
A study testing Enhanced external counterpulsation in people with Hemodialysis, run by Thana Thongsricome, MD at 1 site in Thailand.
Trial summary
The objectives of this study are; To study effect of Enhanced External Counter Pulsation on arterial stiffness, as measured by pulse wave velocity, compared to standard hemodialysis treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Enhanced external counterpulsation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteThailand
- Study dates
- 13 Feb 2020to 31 Mar 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years old or older
- Patients received hemodialysis at King Chulalongkorn Memorial Hospital for at least 3 months
- Patients received hemodialysis frequency for at least 3 times/week with adequate hemodialysis, named single pool Kt/V of 1.2 or more, as calculated by Chula urea kinetic model
- Patients achieving proper dry weight, as determined by clinical assessment or by body composition monitoring (Fresineus company)
Who cannot join
- Patients with severe or unstable disease required emergent specific treatment such as severe infection or hemodynamic instability
- Patients with acute coronary syndrome within 1 month
- Patients received coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty within 3 months
- Patients with severe valvular heart disease and hypertrophic obstructive cardiomyopathy known before inclusion or detected by pre - allocation (within 12 months) echocardiographic assessment
- Patients with cardiac arrhythmia including atrial fibrillation or atrial flutter known before inclusion or detected by pre - allocation (within 12 months) 12 - lead electrocardiography
- Patients with known or suspected deep vein thrombosis or peripheral arterial disease
Show all 12Show fewer
- Patients with thoracic aortic aneurysm detected pre - allocation (within 12 months) echocardiography or abdominal aortic aneurysm detected by pre - allocation (within 12 months) abdominal ultrasonography
- Patients with bleeding diathesis other than uremic bleeding, including anticoagulants use, but antiplatelets or local thrombolytics for vascular access stenosis/thrombosis are not included
- Patients with uncontrolled hypertension, defined as systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg
- Patients with severe pulmonary hypertension known before inclusion or detected by pre - allocation (within 12 months) echocardiographic assessment
- Pregnant patients
- Patients who not willing to give a consent or who cannot legally give a consent
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Chulalongkorn University
Bangkok, Bangkok, 10330
About this study
The objectives of this study are;
- To study effect of Enhanced External Counter Pulsation on arterial stiffness, as measured by pulse wave velocity, compared to standard hemodialysis treatment.
- To study effect of Enhanced External Counter Pulsation on central aortic blood pressure compared to standard hemodialysis treatment.
- To study effect of Enhanced External Counter Pulsation on cardiac index decline during hemodialysis compared to standard hemodialysis treatment.
- To study effect of Enhanced External Counter Pulsation on intradialytic hypotension events compared to standard hemodialysis treatment.
- To study effect of Enhanced External Counter Pulsation on blood biomarkers for endothelial dysfunction and vascular inflammation compared to standard hemodialysis treatment.
- To identify any adverse events from utilizing Enhanced External Counter Pulsation, such as pain or uncomfortable feeling, or even uncontrol hypertension.
- Conditions
- Hemodialysis
- Being tested
- Enhanced external counterpulsation
- Keywords
- Enhanced external counterpulsation, Hemodialysis, Arterial stiffness, Pulse wave velocity, Central aortic blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced external counterpulsationDevice
A device applying external pneumatic cuff pressure to the lower limbs, thighs, and buttock sequentially in the diastolic phase synchronouslty with electrocardiography to assist the cardiac function via diastolic augmentation mechanism.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced external counterpulsation (intervention) group | Experimental | Recieving enhanced external counterpulsation application during hemodialysis Receives: Device: Enhanced external counterpulsation |
| Controlled group | No intervention | Recieve standard hemodialysis with optimal medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse wave velocity
Pulse wave velocity is a well-proven marker of arterial stiffness.
Measured: Baseline, 1.5 months, and 3 months of research
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start13 Feb 2020
- Primary completion13 Feb 2025 (estimated)
- Study completion31 Mar 2025 (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 HemodialysisStudies 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
- Model description
- Non sham-controlled, randomized study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thana Thongsricome, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thana Thongsricome, MD, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608953
- Sponsor's protocol ID
- 246/62
- Other IDs
- TCTR20220202008
- Acronym
- EECP in HD
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Thongsricome T, Kositanurit W, Siwamogsatham S, Tiranathanagul K. Enhanced external counterpulsation, focusing on its effect on kidney function, and utilization in patients with kidney diseases: a systematic review. Asian Biomed (Res Rev News). 2023 Oct 26;17(5):208-221. doi: 10.2478/abm-2023-0062. eCollection 2023 Oct.
PubMed 37899762
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Effect of Enhanced External Counter Pulsation to Arterial Stiffness in Chronic Hemodialysis Patient
- ClinicalTrials.gov ID
- NCT06608953
- Acronym / sponsor ID
- EECP in HD / 246/62
- Conditions
- Hemodialysis
- Keywords
- Enhanced external counterpulsation, Hemodialysis, Arterial stiffness, Pulse wave velocity, Central aortic blood pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Thana Thongsricome, MDUniversity, hospital or other
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 13 Feb 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 23 Sep 2024 (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.
The objectives of this study are;
- To study effect of Enhanced External Counter Pulsation on arterial stiffness, as measured by pulse wave velocity, compared to standard hemodialysis treatment.
- To study effect of Enhanced External Counter Pulsation on central aortic blood pressure compared to standard hemodialysis treatment.
- To study effect of Enhanced External Counter Pulsation on cardiac index decline during hemodialysis compared to standard hemodialysis treatment.
- To study effect of Enhanced External Counter Pulsation on intradialytic hypotension events compared to standard hemodialysis treatment.
- To study effect of Enhanced External Counter Pulsation on blood biomarkers for endothelial dysfunction and vascular inflammation compared to standard hemodialysis treatment.
- To identify any adverse events from utilizing Enhanced External Counter Pulsation, such as pain or uncomfortable feeling, or even uncontrol hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Non sham-controlled, randomized study
| Arm | Type | Receives |
|---|---|---|
| Enhanced external counterpulsation (intervention) group | Experimental | Device: Enhanced external counterpulsationRecieving enhanced external counterpulsation application during hemodialysis |
| Controlled group | No intervention | –Recieve standard hemodialysis with optimal medical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years old or older
- Patients received hemodialysis at King Chulalongkorn Memorial Hospital for at least 3 months
- Patients received hemodialysis frequency for at least 3 times/week with adequate hemodialysis, named single pool Kt/V of 1.2 or more, as calculated by Chula urea kinetic model
- Patients achieving proper dry weight, as determined by clinical assessment or by body composition monitoring (Fresineus company)
Key exclusion criteria (12 listed)
- Patients with severe or unstable disease required emergent specific treatment such as severe infection or hemodynamic instability
- Patients with acute coronary syndrome within 1 month
- Patients received coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty within 3 months
- Patients with severe valvular heart disease and hypertrophic obstructive cardiomyopathy known before inclusion or detected by pre - allocation (within 12 months) echocardiographic assessment
- Patients with cardiac arrhythmia including atrial fibrillation or atrial flutter known before inclusion or detected by pre - allocation (within 12 months) 12 - lead electrocardiography
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 counterpulsationA device applying external pneumatic cuff pressure to the lower limbs, thighs, and buttock sequentially in the diastolic phase synchronouslty with electrocardiography to assist the cardiac function via diastolic augmentation mechanism. | Device | Enhanced external counterpulsation (intervention) group |
Primary outcome
Pulse wave velocity
Time frame: Baseline, 1.5 months, and 3 months of research
Pulse wave velocity is a well-proven marker of arterial stiffness.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Background: PubMed 37899762Thongsricome T, Kositanurit W, Siwamogsatham S, Tiranathanagul K. Enhanced external counterpulsation, focusing on its effect on kidney function, and utilization in patients with kidney diseases: a systematic review. Asian Biomed (Res Rev News). 2023 Oct 26;17(5):208-221. doi: 10.2478/abm-2023-0062. eCollection 2023 Oct.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Hemodialysis, run by Thana Thongsricome, MD at 1 site in Thailand.
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 4 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: status not confirmed, as of the sponsor's last update on 23 Sep 2024. 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 Thailand. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse wave velocity (time frame: Baseline, 1.5 months, and 3 months of research). 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 NCT06608953, 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 23 Sep 2024.