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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04982419
Other study ID # NEPH-019-20S
Secondary ID 1I01CX002045-01
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date November 1, 2021
Est. completion date September 30, 2028

Study information

Verified date December 2023
Source VA Office of Research and Development
Contact Oladipupo Olafiranye, MD MS
Phone (214) 857-2923
Email Oladipupo.Olafiranye@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date September 30, 2028
Est. primary completion date September 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
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)

Locations

Country Name City State
United States VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX Dallas Texas
United States VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Pittsburgh Pennsylvania
United States Hunter Holmes McGuire VA Medical Center, Richmond, VA Richmond Virginia

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Contrast-associated acute kidney injury 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. 24 and 48 hours time points
Secondary 6 minute walk distance At one month follow-up, 6 minute walk test will be used to determine total distance walked in 6 minutes. 1 month
Secondary Major adverse kidney events Persistent renal dysfunction, renal replacement therapy, and death will be assessed at 3 months (90 days) to determine major adverse kidney events (MAKE90). 3 months
Secondary Brain Natriuretic Peptide (BNP) 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. 24 and 48 hours time points
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