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

VA Office of Research and Development

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Coronary Angiography; Percutaneous Coronary Intervention; Acute Kidney Injury; Contrast Induced Nephropathy; Heart Failure

Treatments: Device: Remote ischemic preconditioning; Device: Sham remote ischemic conditioning

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04982419

NEPH-019-20S

1I01CX002045-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Remote ischemic preconditioning

Active Comparator group

Description:

3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes

Treatment:

Device: Remote ischemic preconditioning

Sham remote ischemic preconditioning

Sham Comparator group

Description:

3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)

Treatment:

Device: Sham remote ischemic conditioning