Actively Recruiting
Feasibility Trial for a Right Ventricular Failure Platform Trial
Led by University of Alberta · Updated on 2025-09-18
30
Participants Needed
5
Research Sites
72 weeks
Total Duration
On this page
Sponsors
U
University of Alberta
Lead Sponsor
C
Canadian Heart Function Alliance
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility Trial for a Right Ventricular Failure Platform Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �318 years.
- Able to provide informed consent.
- Able to comply with all study procedures.
- History of right ventricular dysfunction or right heart failure secondary to pulmonary hypertension groups 1, 2, 3, or 4.
- Symptomatic with New York Heart Association Functional Class II-IV.
- Biomarker and echocardiogram evidence of right ventricular dysfunction within 3 months.
- Receiving loop diuretics or mineralocorticoid receptor antagonists for at least 4 weeks.
- Access to an iOS or Android smartphone or tablet.
You will not qualify if you...
- Estimated glomerular filtration rate less than 30 ml/min.
- Left ventricular ejection fraction less than 50%.
- Normal right ventricular size and function.
- Severe aortic or mitral valvular disease.
- Moderate or severe liver dysfunction (Child-Pugh Class B or C).
- Clinical instability requiring increased diuretics.
- Pregnancy or lactation.
- Unable to provide consent or comply with follow-up visits.
- Listed for lung, heart, or combined heart/lung transplantation.
- Myocardial infarction or acute coronary syndrome within 90 days of screening.
- Enrolled in another interventional trial.
- Planned cardiac or thoracic surgery within the next 6 months.
- Known allergy to empagliflozin or ranolazine.
- Concurrent treatment with certain strong CYP 3A4 inhibitors, class IA or III antiarrhythmics, or CYP 3A4 inducers.
- Congenital long QT syndrome or QTc interval greater than 500 ms.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of Calgary
Calgary, Alberta, Canada, T1Y 6J4
Not Yet Recruiting
2
University of Alberta
Edmonton, Alberta, Canada, T6G 2G3
Actively Recruiting
3
The University of British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Not Yet Recruiting
4
London Health Sciences Centre - University Hospital
London, Ontario, Canada, N6A 5A5
Not Yet Recruiting
5
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Not Yet Recruiting
Research Team
J
Jason Weatherald, MD,MSc,FRCPC
CONTACT
C
Courtney Gubbels, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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