Pulmonary HypertensionPhase 2CRAVENCT06570473
Feasibility Trial for a Right Ventricular Failure Platform Trial
A Phase 2 study testing Empagliflozin and Ranolazine in people with Pulmonary Hypertension and Right Ventricular Dysfunction, run by University of Alberta at 5 sites in Canada.
Trial 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 hypertension and right ventricular dysfunction, comparing empagliflozin or ranolazine plus standard of care to standard of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Right Ventricular Dysfunction, Right Heart Failure
- What is being tested?
- Empagliflozin and Ranolazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesCanada
- Study dates
- 15 Jul 2025to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- Symptomatic with current NYHA Functional Class II-IV
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- 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:
- 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.
- Access to an iOS or android smart phone or tablet.
Who cannot join
- Estimated glomerular filtration rate (eGFR) <30 ml/min.
- LVEF < 50%
- Normal RV size and function
- Severe aortic or mitral valvular disease
- Moderate or severe hepatic dysfunction (Child-Pugh Class B or C)
- Participants requiring augmentation of diuretics or otherwise not meeting definition for clinical stability
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- Pregnancy or lactation
- Unable to provide consent and comply with follow-up visits
- Listed for lung, heart or heart/lung transplantation
- 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.
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Not yet recruiting
University of Calgary
Calgary, Alberta, T1Y 6J4
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2G3
- Not yet recruiting
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5
- Not yet recruiting
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
- Not yet recruiting
The University of British Columbia
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Feasibility Trial for the Canadian Right Ventricular AdaptiVE (CRAVE) Platform for Therapies Targeting Right Ventricular Failure
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.
Read the 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 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.
- Being tested
- Empagliflozin, Ranolazine
- Keywords
- Pulmonary Hypertension, Right Ventricular Dysfunction, Right Heart Failure, Empagliflozin, Ranolazine
- Medical subject headings
- Hypertension, Pulmonary, Ventricular Dysfunction, Right, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Also called Jardiance
Tablet
RanolazineDrug
Also called Corzyna
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | Participants in the empagliflozin arm will receive 10 mg by mouth once daily and standard of care. Receives: Drug: Empagliflozin |
| Ranolazine | Experimental | Participants in the ranolazine arm will receive ranolazine 500 mg by mouth twice daily, which will be increased to 1000 mg twice daily after 2 weeks (unless concurrently using moderate CYP 3A4 inhibitors, then dose is limited to 500 mg twice daily) and will receive standard of care. Receives: Drug: Ranolazine |
| Standard of Care | No intervention | Participants in this group will receive standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of eligible participants approached that consent
(target ≥30%)
Measured: 16 weeks
The proportion of participants who consent that are randomized
(target ≥90%)
Measured: 16 weeks
Average enrolment rate of participants per centre per month
(target ≥1 participant per centre/month)
Measured: 16 weeks
Loss of follow up or death
Loss of follow up (target at 16 weeks ≤5%)
Measured: 16 weeks
Ability to capture data for secondary outcomes
(target ≥90% completion)
Measured: 16 weeks
Secondary outcomes (10)
RV function
assessed using echocardiogram
Measured: 16 weeks
Natriuretic peptides
(N-terminal pro-B-type natriuretic peptide [NT-proBNP])
Measured: 16 weeks
Hemodynamics
assessed using right heart catheterization (RHC)
Measured: 16 weeks
Exercise capacity measured virtually
6-minute walk distance (6MWD) assessed using the novel Walk.Talk.Track. mobile app
Measured: 16 weeks
Exercise capacity measured in-person
assessed using in-person 6-minute walk distance (6MWD)
Measured: 16 weeks
NYHA functional class
(New York Heart Association Functional Classification for heart failure)
Measured: 16 weeks
EmPHasis-10
questionnaire used during clinical assessments to determine how pulmonary hypertension affects someone's life
Measured: 16 weeks
KCCQ-12
questionnaire for assessing health-related quality of life in chronic heart failure
Measured: 16 weeks
EQ-5D-5L
questionnaire provides a simple descriptive profile of a respondent's health state
Measured: 16 weeks
Clinical event outcomes
number of clinical events that occur
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start15 Jul 2025
- Primary completion31 Mar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Heart Function Alliance, Accelerating Clinical Trials Consortium, Ottawa Heart Institute Research Corporation, Team PHenomenal Hope
- Responsible party
- Sponsor
- Investigators
- Jason Weatherald, MD,MSc,FRCPC, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570473
- Sponsor's protocol ID
- CRAVE-01
- Acronym
- CRAVE
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial for the Canadian Right Ventricular AdaptiVE (CRAVE) Platform for Therapies Targeting Right Ventricular Failure
- ClinicalTrials.gov ID
- NCT06570473
- Acronym / sponsor ID
- CRAVE / CRAVE-01
- Keywords
- Pulmonary Hypertension, Right Ventricular Dysfunction, Right Heart Failure, Empagliflozin, Ranolazine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Heart Function Alliance, Accelerating Clinical Trials Consortium, Ottawa Heart Institute Research Corporation, Team PHenomenal Hope
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: EmpagliflozinParticipants in the empagliflozin arm will receive 10 mg by mouth once daily and standard of care. |
| Ranolazine | Experimental | Drug: RanolazineParticipants in the ranolazine arm will receive ranolazine 500 mg by mouth twice daily, which will be increased to 1000 mg twice daily after 2 weeks (unless concurrently using moderate CYP 3A4 inhibitors, then dose is limited to 500 mg twice daily) and will receive standard of care. |
| Standard of Care | No intervention | –Participants in this group will receive standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Symptomatic with current NYHA Functional Class II-IV
Key exclusion criteria (18 listed)
- Estimated glomerular filtration rate (eGFR) <30 ml/min.
- LVEF < 50%
- Normal RV size and function
- Severe aortic or mitral valvular disease
- Moderate or severe hepatic dysfunction (Child-Pugh Class B or C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinAlso: JardianceTablet | Drug | Empagliflozin |
| RanolazineAlso: CorzynaTablet | Drug | Ranolazine |
Primary outcome
The proportion of eligible participants approached that consent
Time frame: 16 weeks
(target ≥30%)
The proportion of participants who consent that are randomized
Time frame: 16 weeks
(target ≥90%)
Average enrolment rate of participants per centre per month
Time frame: 16 weeks
(target ≥1 participant per centre/month)
Loss of follow up or death
Time frame: 16 weeks
Loss of follow up (target at 16 weeks ≤5%)
Ability to capture data for secondary outcomes
Time frame: 16 weeks
(target ≥90% completion)
10 secondary outcomes
RV function
Time frame: 16 weeks
Natriuretic peptides
Time frame: 16 weeks
Hemodynamics
Time frame: 16 weeks
Exercise capacity measured virtually
Time frame: 16 weeks
Exercise capacity measured in-person
Time frame: 16 weeks
NYHA functional class
Time frame: 16 weeks
EmPHasis-10
Time frame: 16 weeks
KCCQ-12
Time frame: 16 weeks
EQ-5D-5L
Time frame: 16 weeks
Clinical event outcomes
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Weatherald, MD,MSc,FRCPC principal investigator
University of Alberta
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empagliflozin and Ranolazine in people with Pulmonary Hypertension and Right Ventricular Dysfunction, run by University of Alberta at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason Weatherald, MD,MSc,FRCPC (780-492-9937, weathera@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of eligible participants approached that consent (time frame: 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.