Using remote ischemic preconditioning to protect kidneys and heart in heart failure patients
Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial
This study is testing if a special treatment called remote ischemic preconditioning can help protect the kidneys and heart of heart failure patients during cardiac procedures.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 3 sites (Pittsburgh, Pennsylvania and 2 other locations) |
| Trial ID | NCT04982419 on ClinicalTrials.gov |
What this trial studies
The RICH Trial is a multicenter, randomized clinical trial designed to evaluate the effects of remote ischemic preconditioning on patients with congestive heart failure undergoing cardiac procedures. This study aims to assess its impact on contrast-associated acute kidney injury, functional capacity, and major adverse kidney events. Participants will be randomly assigned to receive either the remote ischemic preconditioning treatment or a sham procedure, with outcomes measured at one and three months post-procedure. The trial focuses on patients with reduced left ventricular ejection fraction and aims to provide insights into improving kidney and heart health during cardiac interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with heart failure and reduced left ventricular ejection fraction who are scheduled for coronary angiography or percutaneous coronary intervention.
Not a fit: Patients with unstable blood pressure, severe renal disease requiring dialysis, or those who cannot provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of acute kidney injury and improve overall outcomes for heart failure patients undergoing cardiac procedures.
How similar studies have performed: Previous studies on remote ischemic preconditioning have shown promising results, suggesting potential benefits in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pittsburgh, Pennsylvania and 2 other locations
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania, United States (Recruiting)
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States (Recruiting)
- Hunter Holmes McGuire VA Medical Center, Richmond, VA — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Oladipupo Olafiranye, MD MS — VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
- Study coordinator: Oladipupo Olafiranye, MD MS
- Email: Oladipupo.Olafiranye@va.gov
- Phone: (214) 857-2923
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.