Remote Ischemic Preconditioning for Heart Failure
(RICH Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byOladipupo Olafiranye, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Unstable BP, Kidney transplant, Pregnancy, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Remote Ischemic Preconditioning for Heart Failure?
Research shows that Remote Ischemic Preconditioning (RIPC) can reduce markers of heart damage during surgery, but its impact on overall health outcomes is still uncertain. While it is considered safe, studies have not yet proven significant clinical benefits for heart surgery patients.
12345How is the treatment Remote Ischemic Preconditioning (RIPC) unique for heart failure?
Remote Ischemic Preconditioning (RIPC) is unique because it involves applying brief periods of reduced blood flow to a part of the body away from the heart, which can help protect the heart from damage. Unlike traditional treatments that directly target the heart, RIPC uses this indirect method to potentially improve heart function and outcomes.
14678Eligibility Criteria
The RICH trial is for adults over 18 with heart failure (LVEF <50%) and suspected coronary artery disease, who are referred for a coronary angiogram or PCI. They should have a risk of kidney injury from the procedure and not be on certain pre-procedure fluids. Excluded are those unable to consent, with extreme blood pressure, on dialysis, pregnant, prisoners, with arm arterial disease or recent contrast media exposure.Inclusion Criteria
You have a high risk of developing acute kidney injury according to the SCAI score.
I am referred for a procedure to check or unblock my heart's arteries.
I may have stable heart disease or a recent heart problem.
+3 more
Exclusion Criteria
I require dialysis for my kidney condition.
I have had a kidney transplant.
Your blood pressure is very high (over 200) or very low (under 80) when you join the study.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo remote ischemic preconditioning or sham procedure during cardiac catheterization and/or percutaneous coronary intervention
Immediate (during procedure)
1 visit (in-person)
Initial Follow-up
Participants are monitored for contrast-associated acute kidney injury with serum creatinine levels measured at 24 and 48 hours post-procedure
48 hours
2 visits (in-person)
Secondary Follow-up
Participants' functional capacity assessed with a 6-minute walk test at one month
1 month
1 visit (in-person)
Long-term Follow-up
Participants are monitored for major adverse kidney events at 3 months
3 months
1 visit (in-person)
Participant Groups
This study tests whether remote ischemic preconditioning can protect kidneys and heart in patients with congestive heart failure undergoing cardiac procedures. Participants will be randomly assigned to receive either the actual preconditioning technique or a sham (fake) intervention without knowing which one they get.
2Treatment groups
Active Control
Placebo Group
Group I: Remote ischemic preconditioningActive Control1 Intervention
3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes
Group II: Sham remote ischemic preconditioningPlacebo Group1 Intervention
3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)
Remote ischemic preconditioning is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Remote ischemic preconditioning for:
- Cardiac protection in children undergoing open-heart surgery
- Renal protection in patients undergoing cardiac catheterization and/or percutaneous coronary intervention
🇺🇸 Approved in United States as Remote ischemic preconditioning for:
- Cardiac protection in patients undergoing open-heart surgery
- Renal protection in patients undergoing cardiac catheterization and/or percutaneous coronary intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PAPittsburgh, PA
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TXDallas, TX
Hunter Holmes McGuire VA Medical Center, Richmond, VARichmond, VA
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Remote preconditioning and cardiac surgery: regrouping after Remote Ischemic Preconditioning for Heart Surgery (RIPHeart) and Effect of Remote Ischemic Preconditioning on Clinical Outcomes in Patients Undergoing Coronary Artery Bypass Surgery (ERICCA). [2020]Remote ischaemic preconditioning (RIPC) is an attractive cardioprotective strategy. Although results from animal studies and phase II study on humans are convincing, it cannot have a role in clinical practice until benefits in clinical outcomes are proven in phase III study. Two phase III studies were recently published [Remote Ischemic Preconditioning for Heart Surgery (RIPHeart) and Effect of Remote Ischemic Preconditioning on Clinical Outcomes in Patients Undergoing Coronary Artery Bypass Surgery (ERICCA)] and this article discusses their design, results and implications.
A Multicenter Trial of Remote Ischemic Preconditioning for Heart Surgery. [2022]Remote ischemic preconditioning (RIPC) is reported to reduce biomarkers of ischemic and reperfusion injury in patients undergoing cardiac surgery, but uncertainty about clinical outcomes remains.
Remote ischaemic preconditioning does not alter perioperative cytokine production in high-risk cardiac surgery. [2020]Remote ischaemic preconditioning (RIPC) is a novel cardioprotective strategy that uses brief intermittent limb ischaemia to protect the myocardium and other organs from perioperative ischaemic damage. The precise mechanism through which this protective effect occurs is unknown, but potentially could be related to changes in blood-borne mediators such as cytokines.
The effects of remote ischaemic preconditioning on coronary artery function in patients with stable coronary artery disease. [2021]Remote ischaemic preconditioning (RIPC) is a cardioprotective intervention invoking intermittent periods of ischaemia in a tissue or organ remote from the heart. The mechanisms of this effect are incompletely understood. We hypothesised that RIPC might enhance coronary vasodilatation by an endothelium-dependent mechanism.
Remote ischemic preconditioning is a safe adjuvant technique to myocardial protection but adds no clinical benefit after on-pump coronary artery bypass grafting. [2022]To evaluate the impact of remote ischemic preconditioning (RIPC) on clinical outcome, biological markers of myocardial injury, and its safety in patients undergoing on-pump coronary artery bypass grafting (CABG).
Circulating nitrite contributes to cardioprotection by remote ischemic preconditioning. [2022]Remote ischemic preconditioning (rIPC) with short episodes of ischemia/reperfusion (I/R) of an organ remote from the heart is a powerful approach to protect against myocardial I/R injury. The signal transduction pathways for the cross talk between the remote site and the heart remain unclear in detail.
Remote ischaemic pre-conditioning does not attenuate ischaemic left ventricular dysfunction in humans. [2016]Remote ischaemic pre-conditioning (RIPC) reduces distant tissue ischaemia reperfusion injury. We tested the hypothesis that RIPC would protect the left ventricle (LV) from ischaemic dysfunction and stunning.
Effect of remote ischaemic preconditioning on walking in people with multiple sclerosis: double-blind randomised controlled trial. [2022]Remote ischaemic preconditioning (RIPC) is the exposure of body parts to brief periods of circulatory occlusion and reperfusion. Recent studies have also shown that RIPC can improve exercise performance in healthy individuals.