A Prospective Randomized Controlled Trial of Effect of Enhanced External Counter Pulsation to Arterial Stiffness in Chronic Hemodialysis Patient

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.

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Key information

Conditions

Hemodialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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
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

Treatment and study plan

Enhanced External Counterpulsation

Device

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Thana Thongsricome, MD

Other

Registry information

Acronym: EECP in HD

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2025
First posted: Sep 23, 2024
Registry last updated: Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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