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.
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 platform trial for testing multiple interventions in various domains to improve right ventricular function. In this feasibility trial, 30 participants with pulmonary hypertension and right heart failure with be randomized 1:1:1 to empagliflozin 10 mg daily + standard of care, ranolazine twice daily + standard of care, or standard of care alone. Participant outcomes (medical records review) will be followed for 16 weeks after randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Tablet
Tablet
University of Calgary
Calgary, Alberta, Canada
NOT_YET_RECRUITINGUniversity of Alberta
Edmonton, Alberta, Canada
RECRUITINGThe University of British Columbia
Vancouver, British Columbia, Canada
NOT_YET_RECRUITINGThe proportion of eligible participants approached that consent
(target ≥30%)
Time frame: 16 weeks
The proportion of participants who consent that are randomized
(target ≥90%)
Time frame: 16 weeks
Average enrolment rate of participants per centre per month
(target ≥1 participant per centre/month)
Time frame: 16 weeks
Loss of follow up or death
Loss of follow up (target at 16 weeks ≤5%)
Time frame: 16 weeks
Ability to capture data for secondary outcomes
(target ≥90% completion)
Time frame: 16 weeks
RV function
assessed using echocardiogram
Time frame: 16 weeks
Natriuretic peptides
(N-terminal pro-B-type natriuretic peptide \[NT-proBNP\])
Time frame: 16 weeks
Hemodynamics
assessed using right heart catheterization (RHC)
Time frame: 16 weeks
Exercise capacity measured virtually
6-minute walk distance (6MWD) assessed using the novel Walk.Talk.Track. mobile app
Time frame: 16 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
London Health Sciences Centre - University Hospital
London, Ontario, Canada
NOT_YET_RECRUITINGThe Ottawa Hospital
Ottawa, Ontario, Canada
NOT_YET_RECRUITINGExercise capacity measured in-person
assessed using in-person 6-minute walk distance (6MWD)
Time frame: 16 weeks
NYHA functional class
(New York Heart Association Functional Classification for heart failure)
Time frame: 16 weeks
EmPHasis-10
questionnaire used during clinical assessments to determine how pulmonary hypertension affects someone's life
Time frame: 16 weeks
KCCQ-12
questionnaire for assessing health-related quality of life in chronic heart failure
Time frame: 16 weeks
EQ-5D-5L
questionnaire provides a simple descriptive profile of a respondent's health state
Time frame: 16 weeks
Clinical event outcomes
number of clinical events that occur
Time frame: 16 weeks