Status:
RECRUITING
Feasibility Trial for a Right Ventricular Failure Platform Trial
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Canadian Heart Function Alliance
Accelerating Clinical Trials Consortium
Conditions:
Pulmonary Hypertension
Right Ventricular Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 hyperte...
Detailed Description
This study is an investigator-initiated, open label, prospective, multi-centre, phase 2, randomized control trial. This CRAVE feasibility trial will seek to establish the feasibility of a larger platf...
Eligibility Criteria
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:
- 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.
Exclusion
- Estimated glomerular filtration rate (eGFR) \<30 ml/min.
- LVEF \< 50%
- Normal RV size and function
- Severe aortic or mitral valvular disease
- 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
- Listed for lung, heart or heart/lung transplantation
- Myocardial infarction or acute coronary syndrome within 90 days of screening
- Enrolled in another interventional trial
- Planned cardiac or thoracic surgical intervention in the next 6 months.
- Known hypersensitivity to empagliflozin or ranolazine.
- 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)
- Congenital long QT syndrome or a QTc interval \>500 ms
Key Trial Info
Start Date :
July 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06570473
Start Date
July 15 2025
End Date
December 1 2026
Last Update
September 18 2025
Active Locations (5)
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1
University of Calgary
Calgary, Alberta, Canada, T1Y 6J4
2
University of Alberta
Edmonton, Alberta, Canada, T6G 2G3
3
The University of British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
4
London Health Sciences Centre - University Hospital
London, Ontario, Canada, N6A 5A5