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

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

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220202008
Enrollment
18
Registered
2022-02-02
Start date
2020-08-12
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End stage renal disease Hemodialysis Vascular stiffness Cardiac ischemia End stage renal disease Hemodialysis Enhanced External Counter Pulsation (EECP) Arterial stiffness Pulse wave velocity

Interventions

Standard hemodialysis therapy for 3 times per week accompanied by Enhanced External Counter Pulsation application for 1 hour per session in every hemodialysis session, within the first 3 hours of hemo
Experimental Device,No Intervention No treatment
Enhanced External Counter Pulsation (EECP) therapy,Control

Sponsors

Ratchadaphiseksompot reseach budget, faculty of medicine, Chulalongkorn university
Lead Sponsor
The kidney foundation of Thailand
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years old or older 2. Patients received hemodialysis at King Chulalongkorn Memorial Hospital for at least 3 months 3. 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 4. Patients achieving proper dry weight, as determined by clinical assessment or by body composition monitoring (Fresineus company)

Exclusion criteria

Exclusion criteria: 1. Patients with severe or unstable disease required emergent specific treatment such as severe infection or hemodynamic instability 2. Patients with acute coronary syndrome within 1 month 3. Patients received coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty within 3 months 4. Patients with significant valvular heart disease and hypertrophic obstructive cardiomyopathy known before inclusion or detected by pre- allocation (within 12 months) echocardiographic assessment 5. Patients with cardiac arrhythmia including atrial fibrillation or atrial flutter known before inclusion or detected by pre -allocation (within 12 months) 12 leads electrocardiography 6. Patients with known or suspected deep vein thrombosis or peripheral arterial disease 7. 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 8. Patients with bleeding diathesis other than uremic bleeding, including anticoagulants use, but antiplatelets or local thrombolytics for vascular access stenosis/thrombosis are not included 9. Patients with uncontrolled hypertension, defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg 10. Patients with severe pulmonary hypertension known before inclusion or detected by pre -allocation (within 12 months) echocardiographic assessment 11. Pregnant patients 12. Patients who not willing to give a consent

Design outcomes

Primary

MeasureTime frame
Arterial stiffness 6 and 12 weeks Pulse wave velocity

Secondary

MeasureTime frame
Central aortic pressure 6 and 12 weeks Noninvasive pulse wave analysis,Cardiac index 1 weeks Dilutional methods via the vascular access,Vascular and cardiac biomarkers 3 months Serum troponin I, nitric oxide, endothelin 1

Countries

Thailand

Contacts

Public ContactThana Thongsricome

Faculty of Medicine, Chulalongkorn University

thana.t@chula.ac.th0813422854

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026