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

Description

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Acute Kidney Injury
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA, Pittsburgh, Pennsylvania, United States, 15240

Dallas

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX, Dallas, Texas, United States, 75216-7167

Richmond

Hunter Holmes McGuire VA Medical Center, Richmond, VA, Richmond, Virginia, United States, 23249-0001

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

Oladipupo Olafiranye, MD MS, PRINCIPAL_INVESTIGATOR, VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Study Record Dates

2028-09-30