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Procedure

Remote Ischemic Preconditioning for Heart Failure (RICH Trial)

Phase 2 & 3
Recruiting
Led By Oladipupo Olafiranye, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Referral for coronary angiogram and/or PCI
Age 18 years
Must not have
Renal disease requiring dialysis
Kidney transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months

Summary

This trial is studying whether a treatment called remote ischemic preconditioning can reduce contrast-associated acute kidney injury, functional capacity, and major adverse kidney events in patients with congestive heart failure undergoing cardiac catheterization and/or percutaneous coronary intervention.

Who is the study for?
The RICH trial is for adults over 18 with heart failure (LVEF <50%) and suspected coronary artery disease, who are referred for a coronary angiogram or PCI. They should have a risk of kidney injury from the procedure and not be on certain pre-procedure fluids. Excluded are those unable to consent, with extreme blood pressure, on dialysis, pregnant, prisoners, with arm arterial disease or recent contrast media exposure.
What is being tested?
This study tests whether remote ischemic preconditioning can protect kidneys and heart in patients with congestive heart failure undergoing cardiac procedures. Participants will be randomly assigned to receive either the actual preconditioning technique or a sham (fake) intervention without knowing which one they get.
What are the potential side effects?
While specific side effects aren't detailed here, remote ischemic preconditioning generally involves brief interruptions of blood flow which could cause discomfort or bruising where the cuff is applied on the arm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am referred for a procedure to check or unblock my heart's arteries.
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I am 18 years old or older.
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My heart's pumping ability is reduced (LVEF <50%).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I require dialysis for my kidney condition.
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I have had a kidney transplant.
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I am unable to understand and agree to the study's details.
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I have poor blood flow in my arm's arteries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Contrast-associated acute kidney injury
Secondary study objectives
6 minute walk distance
Brain Natriuretic Peptide (BNP)
Major adverse kidney events

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Remote ischemic preconditioningActive Control1 Intervention
3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes
Group II: Sham remote ischemic preconditioningPlacebo Group1 Intervention
3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,663 Previous Clinical Trials
3,765,535 Total Patients Enrolled
39 Trials studying Heart Failure
63,107 Patients Enrolled for Heart Failure
Oladipupo Olafiranye, MDPrincipal InvestigatorVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
1 Previous Clinical Trials
110 Total Patients Enrolled
Oladipupo Olafiranye, MD MSPrincipal InvestigatorVA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Media Library

Remote ischemic preconditioning (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04982419 — Phase 2 & 3
Heart Failure Research Study Groups: Remote ischemic preconditioning, Sham remote ischemic preconditioning
Heart Failure Clinical Trial 2023: Remote ischemic preconditioning Highlights & Side Effects. Trial Name: NCT04982419 — Phase 2 & 3
Remote ischemic preconditioning (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04982419 — Phase 2 & 3
~117 spots leftby Sep 2027
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