Heart Failure Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

240

Study ID:

NCT04982419

Recruitment Status:

Recruiting

Sponsor:

VA Office of Research and Development

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There are 3 Locations for this study

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VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh Pennsylvania, 15240, United States More Info
Ning Feng
Contact
412-360-6191
[email protected]
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas Texas, 75216, United States More Info
Oladipupo Olafiranye, MD MS
Contact
214-857-2923
[email protected]
Oladipupo Olafiranye, MD MS
Principal Investigator
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond Virginia, 23249, United States More Info
Ion Jovin
Contact
804-675-5419
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

240

Study ID:

NCT04982419

Recruitment Status:

Recruiting

Sponsor:


VA Office of Research and Development

How clear is this clinincal trial information?

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