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NCT Number: NCT04982419

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

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Key information

Conditions

Acute Kidney Injury Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Contrast Induced Nephropathy Coronary Angiography Coronary Artery Disease Coronary Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Kidney Diseases Male Urogenital Diseases Myocardial Ischemia Percutaneous Coronary Intervention Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: RIPC

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)

Other names: Sham-RIPC

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Oladipupo Olafiranye, MD MS

CONTACT

[email protected]

(214) 857-2923

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: RICH

Important dates

Study start
2021
Primary completion
2028
Study completion
2029
First posted
Jul 29, 2021
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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