Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial
Recruiting · NCT04982419 · Interventional (participants receive a specific treatment) · Lead sponsor: VA Office of Research and Development
View the official record on ClinicalTrials.gov →Interventions studied
Remote ischemic preconditioningSham remote ischemic conditioning
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- Inability to give informed consent
- Unstable BP (SBP \> 200 or \<80 mmHg) at the time of enrolment
- Upper limb peripheral arterial disease
- Unavailability of at least one arm for RIPC/Sham-RIPC application
- Kidney transplant
- Renal disease requiring dialysis
- Prior exposure to contrast media within 72hrs preceding coronary angiography
- Pregnancy
- Prisoner
Where it is running
3 locations listed across 3 US states.
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA - Pittsburgh, Pennsylvania, United States
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX - Dallas, Texas, United States
- Hunter Holmes McGuire VA Medical Center, Richmond, VA - Richmond, Virginia, United States