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

Heart Failure Clinical Trial

— RICH  

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

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

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