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

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT04982419

Collaborator

(none)

240

Enrollment

Locations

Arms

70.9

Anticipated Duration (Months)

120

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Heart Failure Contrast Induced Nephropathy Coronary Angiography Percutaneous Coronary Intervention	Device: Remote ischemic preconditioning Device: Sham remote ischemic conditioning	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Eligible patients will be randomized to RIPC or sham-RIPC.Eligible patients will be randomized to RIPC or sham-RIPC.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Sep 30, 2026

Anticipated Study Completion Date :

Sep 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Remote ischemic preconditioning 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 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes Other Names: RIPC
Sham Comparator: Sham remote ischemic preconditioning 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 3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control) Other Names: Sham-RIPC

Arm

Intervention/Treatment

Active Comparator: Remote ischemic preconditioning

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

3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes

Other Names:

RIPC

Sham Comparator: Sham remote ischemic preconditioning

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

3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)

Other Names:

Sham-RIPC

Outcome Measures

Primary Outcome Measures

Contrast-associated acute kidney injury [24 and 48 hours time points]
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 Outcome Measures

6 minute walk distance [1 month]
At one month follow-up, 6 minute walk test will be used to determine total distance walked in 6 minutes.
Major adverse kidney events [3 months]
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) [24 and 48 hours time points]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania	United States	15240
2	Hunter Holmes McGuire VA Medical Center, Richmond, VA	Richmond	Virginia	United States	23249