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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Remote ischemic preconditioningActive comparator 1 intervention
Group B: Sham remote ischemic preconditioningSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 and 48 hours time points

Secondary outcomes

1

6 minute walk distance

At one month follow-up, 6 minute walk test will be used to determine total distance walked in 6 minutes.

Time frame
1 month
2

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).

Time frame
3 months
3

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.

Time frame
24 and 48 hours time points

Other outcomes

Sponsors and contacts

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