NCT06570473 Feasibility Trial for a Right Ventricular Failure Platform Trial
| NCT ID | NCT06570473 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Alberta |
| Condition | Pulmonary Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-07-15 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-07-15 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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). 7. Receiving loop diuretics or mineralocorticoid receptor antagonists for at least 4 weeks. 8. Access to an iOS or android smart phone or tablet. Exclusion Criteria: 1. Estimated glomerular filtration rate (eGFR) \<30 ml/min. 2. LVEF \< 50% 3. Normal RV size and function 4. Severe aortic or mitral valvular disease 5. Moderate or severe hepatic dysfunction (Child-Pugh Class B or C) 6. Participants requiring augmentation of diuretics or otherwise not meeting definition for clinical stability 7. Pregnancy or lactation 8. Unable to provide consent and comply with follow-up visits 9. Listed for lung, heart or heart/lung transplantation 10. Myocardial infarction or acute coronary syndrome within 90 days of screening 11. Enrolled in another interventional trial 12. Planned cardiac or thoracic surgical intervention in the next 6 months. 13. Known hypersensitivity to empagliflozin or ranolazine. 14. 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) 15. Congenital long QT syndrome or a QTc interval \>500 ms
Contact & Investigator
Jason Weatherald, MD,MSc,FRCPC
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT06570473 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06570473 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06570473 currently recruiting?
Yes, NCT06570473 is actively recruiting participants. Contact the research team at weathera@ualberta.ca for enrollment information.
Where is the NCT06570473 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada, Vancouver, Canada, London, Canada and 1 additional location.
Who is sponsoring the NCT06570473 clinical trial?
NCT06570473 is sponsored by University of Alberta. The principal investigator is Jason Weatherald, MD,MSc,FRCPC at University of Alberta. The trial plans to enroll 30 participants.