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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
240
3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes
3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States
RECRUITINGVA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States
RECRUITINGHunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States
RECRUITINGContrast-associated acute kidney injury
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.
Time frame: 24 and 48 hours time points
6 minute walk distance
At one month follow-up, 6 minute walk test will be used to determine total distance walked in 6 minutes.
Time frame: 1 month
Major adverse kidney events
Persistent renal dysfunction, renal replacement therapy, and death will be assessed at 3 months (90 days) to determine major adverse kidney events (MAKE90).
Time frame: 3 months
Brain Natriuretic Peptide (BNP)
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.
Time frame: 24 and 48 hours time points
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