Recruiting
Phase 2
Phase 3

Remote Ischemic Preconditioning

Sponsor:

VA Office of Research and Development

Code:

NCT04982419

Conditions

Acute Kidney Injury

Heart Failure

Contrast Induced Nephropathy

Coronary Angiography

Percutaneous Coronary Intervention

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Remote ischemic preconditioning

Sham remote ischemic conditioning

Study Details

Brief 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.

Conditions

Acute Kidney Injury

Heart Failure

Contrast Induced Nephropathy

Coronary Angiography

Percutaneous Coronary Intervention

Study ID

NCT04982419

Start date

Nov 1, 2021

Status verified date

Dec, 2025

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: 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 comparator: Sham remote ischemic preconditioning

3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)

Interventions

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)

Primary outcome measure

  • Contrast-associated acute kidney injury [ Time Frame: 24 and 48 hours time points ]

Central Contacts and Locations

Central contacts

Oladipupo Olafiranye, MD MS

(214) 857-2923Oladipupo.Olafiranye@va.gov

Locations

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Recruiting

Pittsburgh, Pennsylvania, United States, 15240

Contacts

Ning Feng

412-360-6191ning.feng@va.gov

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Recruiting

Dallas, Texas, United States, 75216-7167

Contacts

Oladipupo Olafiranye, MD MS

(214) 857-2923Oladipupo.Olafiranye@va.gov

Principal Investigator:

Oladipupo Olafiranye, MD MS

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Recruiting

Richmond, Virginia, United States, 23249-0001

Contacts

Ion Jovin

804-675-5419ion.jovin@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Keywords

  • Contrast-induced acute kidney injury
  • Congestive heart failure
  • Contrast induced nephropathy
  • Coronary angiography
  • Percutaneous coronary intervention
  • Coronary artery disease
  • Remote ischemic conditioning
  • acute coronary syndrome
  • Acute kidney injury
  • Major adverse kidney events
  • Ischemic preconditioning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-12-15.