Trials / Recruiting
RecruitingNCT06570473
Feasibility Trial for a Right Ventricular Failure Platform Trial
Feasibility Trial for the Canadian Right Ventricular AdaptiVE (CRAVE) Platform for Therapies Targeting Right Ventricular Failure
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- University of Alberta · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This study is an investigator-initiated, open label, prospective, multi-centre, phase 2, randomized control trial. This CRAVE feasibility trial will seek to establish the feasibility of a larger platform trial for testing multiple interventions in various domains to improve right ventricular function. In this feasibility trial, 30 participants with pulmonary hypertension and right heart failure with be randomized 1:1:1 to empagliflozin 10 mg daily + standard of care, ranolazine twice daily + standard of care, or standard of care alone. Participant outcomes (medical records review) will be followed for 16 weeks after randomization.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Empagliflozin | Tablet |
| DRUG | Ranolazine | Tablet |
Timeline
- Start date
- 2025-07-15
- Primary completion
- 2026-08-01
- Completion
- 2026-12-01
- First posted
- 2024-08-26
- Last updated
- 2025-09-18
Locations
5 sites across 1 country: Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06570473. Inclusion in this directory is not an endorsement.