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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Kidney Injury, Heart Failure, Contrast Induced Nephropathy, Coronary Angiography, Percutaneous Coronary Intervention

Intervention / Treatment
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* Device: Remote ischemic preconditioning
* Device: Sham remote ischemic conditioning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients will be randomized to RIPC or sham-RIPC.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remote ischemic preconditioning<br>3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes | Device: Remote ischemic preconditioning<br>* 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes<br>* Other names: RIPC;|
| Sham Comparator: Sham remote ischemic preconditioning<br>3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control) | Device: Sham remote ischemic conditioning<br>* 3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)<br>* Other names: Sham-RIPC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 and 48 hours time points | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk distance | At one month follow-up, 6 minute walk test will be used to determine total distance walked in 6 minutes. | 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). | 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. | 24 and 48 hours time points | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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