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

RECRUITINGPhase 2/3Sponsored by VA Office of Research and Development
Actively Recruiting
PhasePhase 2/3
SponsorVA Office of Research and Development
Started2021-11-01
Est. completion2028-03-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites
View on ClinicalTrials.gov →

NCT04982419

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions6

Acute Kidney InjuryContrast-induced NephropathyCoronary AngiographyHeart DiseaseHeart FailurePercutaneous Coronary Intervention

Locations3 sites

Pennsylvania

1 site
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
Ning Feng412-360-6191ning.feng@va.gov

Texas

1 site
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
Oladipupo Olafiranye, MD MS(214) 857-2923Oladipupo.Olafiranye@va.gov

Virginia

1 site
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001
Ion Jovin804-675-5419ion.jovin@va.gov

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