NCT04982419 Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial
| NCT ID | NCT04982419 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | VA Office of Research and Development |
| Condition | Acute Kidney Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2021-11-01 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 240 participants in total. It began in 2021-11-01 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Oladipupo Olafiranye, MD MS
PRINCIPAL INVESTIGATOR
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Frequently Asked Questions
Who can join the NCT04982419 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04982419 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04982419 currently recruiting?
Yes, NCT04982419 is actively recruiting participants. Contact the research team at Oladipupo.Olafiranye@va.gov for enrollment information.
Where is the NCT04982419 trial being conducted?
This trial is being conducted at Pittsburgh, United States, Dallas, United States, Richmond, United States.
Who is sponsoring the NCT04982419 clinical trial?
NCT04982419 is sponsored by VA Office of Research and Development. The principal investigator is Oladipupo Olafiranye, MD MS at VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX. The trial plans to enroll 240 participants.
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