Actively Recruiting
Feasibility Trial for the Canadian Right Ventricular AdaptiVE (CRAVE) Platform for Therapies Targeting Right Ventricular Failure
Led by University of Alberta · Updated on 2025-09-18
30
Participants Needed
5
Research Sites
17 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
Researchers are evaluating the feasibility of a larger platform trial called CRAVE to test multiple treatments aimed at improving right ventricular function in people with pulmonary hypertension and right heart failure. This phase 2, randomized, open-label trial will include 30 participants to compare the effects of empagliflozin, ranolazine, both added to standard care, against standard care alone. The study seeks to determine whether a larger trial can be successfully conducted by assessing recruitment, consent, and data collection processes. Participants will be randomly assigned to one of three groups: empagliflozin 10 mg once daily plus standard care, ranolazine starting at 500 mg twice daily then increasing to 1000 mg twice daily after two weeks (or 500 mg twice daily if taking certain other medications) plus standard care, or standard care alone. The treatment period lasts 16 weeks, during which participants will be monitored and their outcomes recorded. During the 16-week study, participants will undergo various assessments including medical record review to track right ventricular function, exercise capacity (both virtual and in-person), biomarker levels, hemodynamics, and quality of life using several questionnaires. Researchers will also monitor enrollment rates, loss to follow-up, and ability to gather comprehensive data. This thorough monitoring aims to inform the design of a larger future trial. Participation involves regular follow-up and data collection but no blinding or placebo control.
CONDITIONS
Brief Title
Feasibility Trial for a Right Ventricular Failure Platform Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able to provide informed consent
- Able to comply with all study procedures
- History of right ventricular dysfunction or right heart failure due to pulmonary hypertension groups 1, 2, 3, or 4
- Symptomatic with NYHA 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 (eGFR) less than 30 ml/min
- Left ventricular ejection fraction (LVEF) less than 50%
- Normal right ventricular size and function
- Severe aortic or mitral valvular disease
- Moderate or severe hepatic dysfunction (Child-Pugh Class B or C)
- Need for increased diuretics or clinical instability
- Pregnancy or lactation
- Unable to provide consent or comply with follow-up
- Listed for lung, heart, or heart/lung transplant
- Recent myocardial infarction or acute coronary syndrome within 90 days
- Enrolled in another interventional trial
- Planned cardiac or thoracic surgery in next 6 months
- Known allergy to empagliflozin or ranolazine
- Concurrent treatment with strong CYP 3A4 inhibitors, certain antiarrhythmics, or CYP 3A4 inducers
- Congenital long QT syndrome or QTc interval over 500 ms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive empagliflozin, ranolazine, or standard of care to improve right ventricular function.
Visits occur as per standard care and study requirements during the 16-week treatment period
Duration - Up to 16 weeks after randomization
Participants are followed for outcomes and safety monitoring after treatment.
Data collection through medical record reviews and possible follow-up assessments
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
C
Courtney Gubbels, BA
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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