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

NCT04982419 | Recruiting Phase 2 DMC FDA Device

• 2 other identifiers: NEPH-019-20S1I01CX002045-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Contrast-induced acute kidney injury; Congestive heart failure; Contrast induced nephropathy; Coronary angiography; Percutaneous coronary intervention; Coronary artery disease; Remote ischemic conditioning; acute coronary syndrome; Acute kidney injury; Major adverse kidney events; Ischemic preconditioning

Outcome Measures

Primary Outcomes (1)

• Contrast-associated acute kidney injury

  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.

  24 and 48 hours time points

Secondary Outcomes (3)

• 6 minute walk distance

  1 month

• Major adverse kidney events

  3 months

• Brain Natriuretic Peptide (BNP)

  24 and 48 hours time points

Study Arms (2)

Remote ischemic preconditioning

ACTIVE COMPARATOR

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

Device: Remote ischemic preconditioning

Sham remote ischemic preconditioning

SHAM COMPARATOR

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

Device: Sham remote ischemic conditioning

Interventions

Remote ischemic preconditioning DEVICE

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

Also known as: RIPC

Remote ischemic preconditioning

Sham remote ischemic conditioning DEVICE

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

Also known as: Sham-RIPC

Sham remote ischemic preconditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

RECRUITING

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216-7167, United States

RECRUITING

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249-0001, United States

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Heart Failure; Coronary Artery Disease; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Oladipupo Olafiranye, MD MS

  VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oladipupo Olafiranye, MD MS

CONTACT

(214) 857-2923; Oladipupo.Olafiranye@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Eligible patients will be randomized to RIPC or sham-RIPC.

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: July 29, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)