A Phase 2 interventional study of Empagliflozin and Ranolazine in Pulmonary Hypertension, Right Ventricular Dysfunction and Right Heart Failure, sponsored by University of Alberta. Recruiting at 5 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by University of Alberta · Phase 2, Interventional, and Treatment
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.
1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.
This study's planned enrollment of 30 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
History of RV dysfunction or RHF secondary to any of:
a. Group 1 PH, pulmonary arterial hypertension b. Group 2 PH, left heart disease with normal (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.
Biomarker and 2D echocardiogram evidence of RV dysfunction within 3 months:
i. TAPSE ≤18 mm ii. RV dilatation (RV diameter > 42 mm at the base).
Exclusion Criteria:
Concurrent treatment with:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the empagliflozin arm will receive 10 mg by mouth once daily and standard of care.
Drug: Empagliflozin
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.
Drug: Ranolazine
Participants in this group will receive standard of care.
Tablet
Also known as: Jardiance
Tablet
Also known as: Corzyna
The 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
Exercise 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
Plan to share: No — There is no plan to share individual participant data.
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Mar 2027, 20 months after the start.
Of 50 phase 2 interventional studies under Hypertension, Pulmonary, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 71. This study's planned 20 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 15, 2026: primary completion Aug 2026 → Mar 2027 and completion Dec 2026 → Jun 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Empagliflozin · Ranolazine