Can diabetes and heart drugs help failing right hearts? new trial launches
NCT ID NCT06570473
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 2 trial is testing whether two existing drugs, empagliflozin (used for diabetes) and ranolazine (used for chest pain), can improve right heart function in 30 people with pulmonary hypertension and right heart failure. Participants will receive one of the drugs plus standard care, or standard care alone. The main goal is to see if a larger study is feasible, not yet to prove the drugs work.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Empagliflozin (Jardiance) and Ranolazine (Corzyna)
- What this could lead to
- If successful, this could point toward new treatment options for right heart failure in people with pulmonary hypertension.
- What could go wrong
- This is a small, early feasibility trial with only 30 people, so results may not apply to everyone. The main goal is to see if a larger trial is possible, not to prove the drugs work.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years. 2. Able to provide informed consent. 3. Able to comply with all study procedures. 4. 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 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. 5. Symptomatic with current NYHA Functional Class II-IV 6. Biomarker and 2D echocardiogram evidence of RV dysfunction within 3 months: 1. 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 2. A quantitative 2D echocardiogram with evidence of RV dysfunction defined as having both of the following: i. TAPSE ≤18 mm ii. RV dilatation (RV diameter \> 42 mm at the base). 7. Receiving loop diuretics or mineralocorticoid receptor antagonists for at least 4 weeks. 8. Access to an iOS or android smart phone or tablet. Exclusion Criteria: 1. Estimated glomerular filtration rate (eGFR) \<30 ml/min. 2. LVEF \< 50% 3. Normal RV size and function 4. Severe aortic or mitral valvular disease 5. Moderate or severe hepatic dysfunction (Child-Pugh Class B or C) 6. Participants requiring augmentation of diuretics or otherwise not meeting definition for clinical stability 7. Pregnancy or lactation 8. Unable to provide consent and comply with follow-up visits 9. Listed for lung, heart or heart/lung transplantation 10. Myocardial infarction or acute coronary syndrome within 90 days of screening 11. Enrolled in another interventional trial 12. Planned cardiac or thoracic surgical intervention in the next 6 months. 13. Known hypersensitivity to empagliflozin or ranolazine. 14. 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) 15. Congenital long QT syndrome or a QTc interval \>500 ms
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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London Health Sciences Centre - University Hospital
NOT_YET_RECRUITINGLondon, Ontario, N6A 5A5, Canada
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The Ottawa Hospital
NOT_YET_RECRUITINGOttawa, Ontario, K1Y 4E9, Canada
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The University of British Columbia
NOT_YET_RECRUITINGVancouver, British Columbia, V5Z 1M9, Canada
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University of Alberta
RECRUITINGEdmonton, Alberta, T6G 2G3, Canada
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University of Calgary
NOT_YET_RECRUITINGCalgary, Alberta, T1Y 6J4, Canada
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