Feasibility Trial for a Right Ventricular Failure Platform Trial

Sponsor
University of Alberta
Study ID
NCT06570473
Phase
PHASE2
Status
Recruiting
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Conditions

  • Pulmonary Hypertension
  • Right Heart Failure
  • Right Ventricular Dysfunction

Eligibility Criteria

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

Interventions

Study Details

The primary objective of the CRAVE feasibility trial is to assess the feasibility of conducting a larger CRAVE platform trial by performing a randomized trial of 30 participants with pulmonary hypertension and right ventricular dysfunction, comparing empagliflozin or ranolazine plus standard of care to standard of care alone.

Key Dates

Start date
Jul 15, 2025
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin
    Participants in the empagliflozin arm will receive 10 mg by mouth once daily and standard of care.
  • Experimental: Ranolazine
    Participants in the ranolazine arm will receive ranolazine 500 mg by mouth twice daily, which will be increased to 1000 mg twice daily after 2 weeks (unless concurrently using moderate CYP 3A4 inhibitors, then dose is limited to 500 mg twice daily) and will receive standard of care.
  • No Intervention: Standard of Care
    Participants in this group will receive standard of care.

Primary Outcome Measure

The proportion of eligible participants approached that consent [ Time Frame: 16 weeks ]

Central Contacts

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