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

Phase 2

Active, not recruiting

• Conditions: End stage renal diseaseHemodialysisVascular stiffnessCardiac ischemia; End stage renal disease; Enhanced External Counter Pulsation (EECP); Hemodialysis; Arterial stiffness; Pulse wave velocity

• Registration Number: TCTR20220202008
• Lead Sponsor: Ratchadaphiseksompot reseach budget, faculty of medicine, Chulalongkorn university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-02
• Study Completion: 2022-06-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 18

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arterial stiffness 6 and 12 weeks Pulse wave velocity

Secondary Outcome Measures

Name	Time	Method
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