Feasibility Trial for the Canadian Right Ventricular AdaptiVE (CRAVE) Platform for Therapies Targeting Right Ventricular Failure
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.
• Age ≥ 18 years.
• Able to provide informed consent.
• Able to comply with all study procedures.
• 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.
• Symptomatic with current NYHA Functional Class II-IV
• Biomarker and 2D echocardiogram evidence of RV dysfunction within 3 months:
‣ 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
⁃ A quantitative 2D echocardiogram with evidence of RV dysfunction defined as having both of the following:
• i. TAPSE ≤18 mm ii. RV dilatation (RV diameter \> 42 mm at the base).
• Receiving loop diuretics or mineralocorticoid receptor antagonists for at least 4 weeks.
• Access to an iOS or android smart phone or tablet.