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 Criteria:
-
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.
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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.
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Access to an iOS or android smart phone or tablet.
Exclusion Criteria:
-
Estimated glomerular filtration rate (eGFR) <30 ml/min.
-
LVEF < 50%
-
Normal RV size and function
-
Severe aortic or mitral valvular disease
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Moderate or severe hepatic dysfunction (Child-Pugh Class B or C)
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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
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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.
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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