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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
RICH Trial 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.Check my eligibility
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.See study design
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.
RICH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am referred for a procedure to check or unblock my heart's arteries.
Select...
I am 18 years old or older.
Select...
My heart's pumping ability is reduced (LVEF <50%).
RICH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Contrast-associated acute kidney injury
Secondary outcome measures
6 minute walk distance
Brain Natriuretic Peptide (BNP)
Major adverse kidney events
RICH 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
1,611 Previous Clinical Trials
3,305,044 Total Patients Enrolled
38 Trials studying Heart Failure
62,948 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I require dialysis for my kidney condition.You have a high risk of developing acute kidney injury according to the SCAI score.I have had a kidney transplant.Your blood pressure is very high (over 200) or very low (under 80) when you join the study.I am unable to understand and agree to the study's details.I have been exposed to contrast dye within the last 3 days before my heart imaging test.I am referred for a procedure to check or unblock my heart's arteries.I may have stable heart disease or a recent heart problem.I have poor blood flow in my arm's arteries.You do not have at least one arm available for a certain type of treatment.I am 18 years old or older.My heart's pumping ability is reduced (LVEF <50%).I am restricted from receiving normal saline IV fluids before a procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Remote ischemic preconditioning
- Group 2: Sham remote ischemic preconditioning
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are taking part in this clinical research?
"The most recent information on clinicaltrials.gov says that this trial is still recruiting patients. The posting date was 11/1/2021, and the last update occurred on 11/2/2022. There are plans to enroll 240 participants at 2 locations."
Answered by AI
Are we currently looking for new participants in this clinical trial?
"This research project is still recruiting test subjects, with the first posting on clinicaltrials.gov being November 1st, 2021 and the most recent update coming on November 2nd, 2022."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
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