Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial
Who is this study for? Patients with Acute Kidney Injury, Heart Failure
What treatments are being studied? Remote Ischemic Preconditioning
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age 18 years
• Diagnosis of heart failure with reduced LVEF \<50%
• Pre-procedure intravenous normal saline fluid restriction status
• Society for Cardiovascular Angiography and Interventions (SCAI) AKI risk score (\>1%)
• Referral for coronary angiogram and/or PCI
• Suspected stable coronary artery disease or acute coronary syndrome
Locations
United States
Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
RECRUITING
Pittsburgh
Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
RECRUITING
Dallas
Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA
RECRUITING
Richmond
Contact Information
Primary
Oladipupo Olafiranye, MD MS
Oladipupo.Olafiranye@va.gov
(214) 857-2923
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 240
Treatments
Active_comparator: Remote ischemic preconditioning
3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes
Sham_comparator: Sham remote ischemic preconditioning
3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)
Authors
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development