Feasibility Trial for a Right Ventricular Failure Platform Trial
Trial Parameters
Brief 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.
Eligibility Criteria
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 'mild' RV dysfunction on echocardiography OR NT-proBNP\<300 ng/L and qualitative evidence of at least moderate RV dysfunction and/or dilatation on 2D echocardiogram AND 2. A quantitative 2D echocardio