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

December 9, 2025 updated by: VA Office of Research and Development
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • Recruiting
        • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75216-7167
        • Recruiting
        • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
        • Contact:
        • Principal Investigator:
          • Oladipupo Olafiranye, MD MS
    • Virginia
      • Richmond, Virginia, United States, 23249-0001
        • Recruiting
        • Hunter Holmes McGuire VA Medical Center, Richmond, VA
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Remote ischemic preconditioning
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
3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes
Other Names:
  • RIPC
Sham Comparator: Sham remote ischemic preconditioning
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
3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)
Other Names:
  • Sham-RIPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contrast-associated acute kidney injury
Time Frame: 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.
24 and 48 hours time points

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 minute walk distance
Time Frame: 1 month
At one month follow-up, 6 minute walk test will be used to determine total distance walked in 6 minutes.
1 month
Major adverse kidney events
Time Frame: 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).
3 months
Brain Natriuretic Peptide (BNP)
Time Frame: 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.
24 and 48 hours time points

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Oladipupo Olafiranye, MD MS, VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (Actual)

July 29, 2021

Study Record Updates

Last Update Posted (Estimated)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEPH-019-20S
  • 1I01CX002045-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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