Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial
NCT04982419 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2025-12-15
Summary
This is a prospective, double-blind, sham-controlled, multicenter, randomized clinical trial is to study the effects of remote ischemic preconditioning on contrast-associated acute kidney injury, functional capacity, and major adverse kidney events in in patients with congestive heart failure undergoing cardiac catheterization and/or percutaneous coronary intervention.
Conditions
- Acute Kidney Injury
- Heart Failure
- Contrast Induced Nephropathy
- Coronary Angiography
- Percutaneous Coronary Intervention
Interventions
- DEVICE
-
Sham remote ischemic conditioning
3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)
- DEVICE
-
Remote ischemic preconditioning
3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes
Sponsors & Collaborators
-
VA Office of Research and Development
lead FED
Principal Investigators
-
Oladipupo Olafiranye, MD MS · VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-01
- Primary Completion
- 2028-03-31
- Completion
- 2029-03-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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