Feasibility Trial for a Right Ventricular Failure Platform Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years.
Able to provide informed consent.
Able to comply with all study procedures.
Symptomatic with current NYHA Functional Class II-IV
Disqualifiers
Estimated glomerular filtration rate (eGFR) <30 ml/min.
LVEF < 50%
Normal RV size and function
Severe aortic or mitral valvular disease
Trial design
Treatments tested in this trial
- Empagliflozin
- Ranolazine
Treatment groups
30 Participants
are divided into 3 treatment groupsLocations
5University of CalgaryT1Y 6J4, CalgaryAlberta, Canada
University of AlbertaT6G 2G3, EdmontonAlberta, Canada
The University of British ColumbiaV5Z 1M9, VancouverBritish Columbia, Canada
London Health Sciences Centre - University HospitalN6A 5A5, LondonOntario, Canada
Sponsors and collaborators
University of Alberta
Lead sponsor
Canadian Heart Function Alliance
Collaborator
Accelerating Clinical Trials Consortium
Collaborator
Ottawa Heart Institute Research Corporation
Collaborator
Team PHenomenal Hope
Collaborator
Source ClinicalTrials.gov