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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
VA Office of Research and Development
Study ID
NCT04982419
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Remote ischemic preconditioning — DEVICE
    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 — DEVICE
    3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)

Study Details

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.

Key Dates

Start date
Nov 1, 2021
Status verified
Dec 2025
Primary completion
Mar 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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)

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PAPittsburghPennsylvania15240
Ning Feng
[email protected]
412-360-6191
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TXDallasTexas75216-7167
Oladipupo Olafiranye, MD MS
[email protected]
(214) 857-2923
Oladipupo Olafiranye, MD MS (PRINCIPAL_INVESTIGATOR)
Hunter Holmes McGuire VA Medical Center, Richmond, VARichmondVirginia23249-0001
Ion Jovin
[email protected]
804-675-5419

Find similar trials in Pittsburgh, PA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA· Pittsburgh, PAVA North Texas Health Care System Dallas VA Medical Center, Dallas, TX· Dallas, TXHunter Holmes McGuire VA Medical Center, Richmond, VA· Richmond, VA

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