Tests empagliflozin and ranolazine for heart strain from pulmonary hypertension
Tests two heart drugs in adults with pulmonary hypertension and weakened right heart function.
Plain-language title generated from the registry record
Registry title: Feasibility Trial for a Right Ventricular Failure Platform Trial
Key facts
- Where
- Calgary, Edmonton, London, Ottawa, and Vancouver, CanadaSee the 5 sites
- Phase
- Phase 2
Where in Canada
- University Of CalgaryCalgary, CanadaNot yet recruiting
- University of AlbertaEdmonton, CanadaTaking people
- London Health Sciences Centre, University HospitalLondon, CanadaNot yet recruiting
- The Ottawa HospitalOttawa, CanadaNot yet recruiting
- The University of British ColumbiaVancouver, CanadaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Alberta
- Trial code
- NCT06570473
- Record updated
- 15 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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:; 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:; 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.
Exclusion: Concurrent treatment with:; strong inhibitors of Cytochrome P450 3A4 (CYP 3A4), (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, nelfinavir, ritonavir, indinavir, saquinavir and grapefruit juice); class IA antiarrhythmics (e.g., quinidine, procainamide, disopyramide) or class III antiarrhythmics (e.g., sotalol, ibutilide, amiodarone, dronedarone); inducers of CYP 3A4 (e.g., rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort); Severe aortic or mitral valvular disease; Listed for lung, heart or heart/lung transplantation; Myocardial infarction or acute coronary syndrome within 90 days of screening; Planned cardiac or thoracic surgical intervention in the next 6 months; Known hypersensitivity to empagliflozin or ranolazine; Estimated glomerular filtration rate (eGFR) <30 ml/min; LVEF < 50%; Congenital long QT syndrome or a QTc interval >500 ms; Normal RV size and function; Moderate or severe hepatic dysfunction (Child-Pugh Class B or C); Participants requiring augmentation of diuretics or otherwise not meeting definition for clinical stability; Pregnancy or lactation; Unable to provide consent and comply with follow-up visits; Enrolled in another interventional trial.