Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial

Phase 2

Recruiting

• Conditions: Coronary Angiography; Percutaneous Coronary Intervention; Acute Kidney Injury; Heart Failure; Contrast Induced Nephropathy
• Interventions: Device: Remote ischemic preconditioning; Device: Sham remote ischemic conditioning

• Registration Number: NCT04982419
• Lead Sponsor: VA Office of Research and Development

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.

Detailed Description

The RICH Trial is a prospective, multicenter, randomized clinical trial to determine the effect of remote ischemic preconditioning on contrast associated acute kidney injury, and to characterize the effect of remote ischemic preconditioning on brain natriuretic peptide, functional capacity at one month, and major adverse kidney events (persistent renal dysfunction, renal replacement therapy, and death) at three months in patients with congestive heart failure with reduced left ventricular ejection fraction undergoing coronary angiography and/or percutaneous coronary intervention.

Study Timeline

• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-07-29
• Study Start: 2021-11-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-27
• Last Update Posted: 2024-12-30
• Primary Completion: 2028-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote ischemic preconditioning	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 remote ischemic preconditioning	Sham remote ischemic conditioning	3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)

Primary Outcome Measures

Name	Time	Method
Contrast-associated acute kidney injury	24 and 48 hours time points	The investigators define contrast-associated acute kidney injury as a relative increase in serum creatinine of 0.3mg/dl compared with initial creatinine at 48 hours time point after coronary angiography and/or PCI. The will obtain levels of serum creatinine at baseline, then at 24 and 48 hours time points.

Secondary Outcome Measures

Name	Time	Method
Brain Natriuretic Peptide (BNP)	24 and 48 hours time points	BNP is a hormone that is primarily secreted from the ventricular myocardium in response to hemodynamic stimuli such as ventricular volume expansion and pressure overload. The investigators will obtain levels of serum BNP at baseline, then at 24 and 48 hours.
6 minute walk distance	1 month	At one month follow-up, 6 minute walk test will be used to determine total distance walked in 6 minutes.
Major adverse kidney events	3 months	Persistent renal dysfunction, renal replacement therapy, and death will be assessed at 3 months (90 days) to determine major adverse kidney events (MAKE90).

Trial Locations

Locations (3)

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