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

NCT ID: NCT04982419

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2029-03-31

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.

Conditions

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

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible patients will be randomized to RIPC or sham-RIPC.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Remote ischemic preconditioning

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

Group Type ACTIVE_COMPARATOR

Remote ischemic preconditioning

Intervention Type DEVICE

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

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)

Group Type SHAM_COMPARATOR

Sham remote ischemic conditioning

Intervention Type DEVICE

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

Interventions

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Remote ischemic preconditioning

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

Intervention Type 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)

Intervention Type DEVICE

Other Intervention Names

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RIPC Sham-RIPC

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oladipupo Olafiranye, MD MS

Role: PRINCIPAL_INVESTIGATOR

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Locations

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VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, United States

Site Status RECRUITING

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Oladipupo Olafiranye, MD MS

Role: CONTACT

Phone: (214) 857-2923

Email: [email protected]

Facility Contacts

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Ning Feng

Role: primary

Oladipupo Olafiranye, MD MS

Role: primary

Ion Jovin

Role: primary

Other Identifiers

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1I01CX002045-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NEPH-019-20S

Identifier Type: -

Identifier Source: org_study_id