Clinical trial NCT04982419: Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial
Official title: Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Acute Kidney Injury
Heart Failure
Contrast Induced Nephropathy
Coronary Angiography
Percutaneous Coronary Intervention
Keywords: Contrast-induced acute kidney injury
Congestive heart failure
Contrast induced nephropathy
Coronary angiography
Percutaneous coronary intervention
Coronary artery disease
Remote ischemic conditioning
acute coronary syndrome
Acute kidney injury
Major adverse kidney events
Ischemic preconditioning
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-07-29
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomized to RIPC or sham-RIPC.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Contrast-associated acute kidney injury
timeFrame: 24 and 48 hours time points
Secondary outcomes:
measure: 6 minute walk distance
timeFrame: 1 month
measure: Major adverse kidney events
timeFrame: 3 months
measure: Brain Natriuretic Peptide (BNP)
timeFrame: 24 and 48 hours time points
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
city: Dallas
country: United States
facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
state: Texas
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center, Richmond, VA
state: Virginia
Study officials:
affiliation: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
name: Oladipupo Olafiranye, MD MS
role: PRINCIPAL_INVESTIGATOR
References: