About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Remote ischemic preconditioning
Device3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes
Sham remote ischemic conditioning
Device3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)
Treatment groups
Trial outcomes
Primary outcomes
Contrast-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.
Secondary outcomes
6 minute walk distance
At one month follow-up, 6 minute walk test will be used to determine total distance walked in 6 minutes.
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).
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.
Sponsors and contacts
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