Feasibility Trial for a Right Ventricular Failure Platform Trial
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
| Condition(s) | Pulmonary Hypertension, Right Ventricular Dysfunction, Right Heart Failure |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Age ≥ 18 years. 2. Able to provide informed consent. 3. Able to comply with all study procedures. 4. History of RV dysfunction or RHF secondary to any of: a. Group 1 PH, pulmonary arterial hypertension b. Group 2 PH, left heart disease with normal left ventricular ejection fraction (LVEF) \> 50% and a previous RHC demonstrating combined pre and post-capillary PH, defined as: i. mPAP \>20 mmHg ii. PAWP \> 15 mmHg iii. PVR\> 2 WU c. Group 3 PH d. Group 4 PH, chronic thromboembolic PH that is either persistent after pulmonary endarterectomy or inoperable due to distal disease. 5. Symptomatic with current NYHA Functional Class II-IV 6. Biomarker and 2D echocardiogram evidence of RV dysfunction within 3 months: 1. NT-proBNP \>300 ng/L and qualitative evidence of at least |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Alberta |
| Locations | Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; London, Ontario, Canada; Ottawa, Ontario, Canada |
| Start date | 2025-07-15 |
| NCT ID | NCT06570473 |
| Official listing | https://clinicaltrials.gov/study/NCT06570473 |