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New treatment option for Acute Kidney Injury
Official title Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial
ClinicalTrials.gov ID: NCT04982419
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
- Dallas, Texas, United States
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States; Dallas, Texas, United States; Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.