Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04982419

Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial

Status
Recruiting
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
240 (estimated)
Sponsor
VA Office of Research and Development · Federal
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

The RICH Trial is a prospective, multicenter, randomized clinical trial to determine the effect of remote ischemic preconditioning on contrast associated acute kidney injury, and to characterize the effect of remote ischemic preconditioning on brain natriuretic peptide, functional capacity at one month, and major adverse kidney events (persistent renal dysfunction, renal replacement therapy, and death) at three months in patients with congestive heart failure with reduced left ventricular ejection fraction undergoing coronary angiography and/or percutaneous coronary intervention.

Conditions

Interventions

TypeNameDescription
DEVICERemote ischemic preconditioning3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes
DEVICESham remote ischemic conditioning3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)

Timeline

Start date
2021-11-01
Primary completion
2028-03-31
Completion
2029-03-31
First posted
2021-07-29
Last updated
2025-12-15

Locations

3 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04982419. Inclusion in this directory is not an endorsement.