NCT06608953Enrolling By InvitationNot Applicable
A Prospective Randomized Controlled Trial of Effect of Enhanced External Counter Pulsation to Arterial Stiffness in Chronic Hemodialysis Patient
Thana Thongsricome, MD2 sites in 1 country14 target enrollmentStarted: February 13, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Pulse wave velocity
Study Overview
Brief 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.
- 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Dana analysis personnels are blinded to the reaserch arms. The subjects are not blinded to the treatment (not sham-controlled).
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Thana Thongsricome, MD
Principal investigator
Chulalongkorn University
Study Sites (2)
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