Could a diabetes pill strengthen the right heart in lung hypertension?
NCT ID NCT06992440
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 6 times
Summary
This study tests whether empagliflozin, a diabetes medicine, can improve right heart function in 78 adults with pulmonary arterial hypertension (PAH). Participants continue their usual PAH treatments and receive either empagliflozin or a placebo. The main goal is to see if the drug increases the heart's pumping ability, measured by MRI.
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 78 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Sep 2030
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: * In order to be eligible to participate in this study, an individual must meet all the following criteria: 1. Provision of signed and dated informed consent form 2. Ability and stated willingness to comply with all study procedures and availability for the duration of the study 3. Ability to read and write in English 4. Male or female, aged 18 years or older, with group 1 PAH, idiopathic, heritable, associated with drugs and toxins, associated with connective tissue disease and with congenital heart disease (simple repaired or unrepaired defects) according to the current guidelines and adjudicated by the local PI 5. PAH confirmed by right heart catheterization in the last 5 years 6. RV dysfunction defined as FAC ≤ 40.0% on echocardiography performed during the screening visit. In PVDOMICS, FAC has a strong correlation with CMR RV ejection fraction; group 1 PAH patients with an FAC ≤ 40% (mean 27.0 ± 8.0%) had a mean RV ejection fraction of 35.5 ± 11.3% CMR RV ejection fraction ≤ 54% classifies PAH as intermediate (37-54%) or high (\<37%) risk under current guidelines. However, to ensure we recruit patients with significantly impaired RV function, patients with RV FAC between 35.0-40.0% on the screening echocardiogram will have to meet at least one of the following additional criteria: a) TAPSE/sPAP ratio \< 0.31 mm/mmHg; b) elevated right atrial pressure defined as inferior vena cava (IVC) \> 2.1 cm in diameter and the IVC does not collapse with sniff/respiration; c) RV enlargement defined as RV basal diameter ≥ 4.1 cm; d) RV free wall longitudinal strain ≥ -22%; e) Interventricular septal flattening; and f) RV outflow tract mid or late systolic notching. 7. On FDA-approved PAH-targeted therapy (any combination including infused prostacyclin analogues and sotatercept) with stable doses for at least 8 weeks or 24 weeks for sotatercept prior to the screening visit and no clinical plans to change this therapy. 8. Diuretic doses stable for at least 4 weeks prior to screening. After screening, diuretic doses may be changed as directed by the site PIs and/or the treating physician. 9. Ability to take oral medication and willingness to adhere to the study drug regimen. 10. For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 2 weeks after the end of study drug administration 11. Able to have baseline and week 24 CMR according to Imaging Core criteria, as adjudicated by the Site PI Exclusion Criteria: * An individual who meets any of the following criteria will be excluded from participation in this study: 1. Current use of insulin, insulin secretagogues (sulfonylureas and meglitinides), lithium or an SGLT2 inhibitor 2. Use of an SGLT2 inhibitor within the past 3 months prior to screening 3. Prior documented inability to tolerate an SGLT2 inhibitor 4. Volume depletion, as ascertained by the site PI, at screening or baseline 5. History of diabetic ketoacidosis or type 1 diabetes mellitus 6. Chronic alcohol or drug abuse 7. More than one bacterial or yeast genitourinary tract infection in the year prior to enrollment 8. Estimated glomerular filtration rate under 30 mL/minute/1.73m2 or on renal replacement therapy 9. Pregnancy or lactation 10. Known allergy or hypersensitivity to empagliflozin or another SGLT-2 inhibitor 11. Currently taking or has taken another investigational drug within the past 4 weeks 12. Enrollment in another randomized intervention trial. (Participants participating in observational trials will not be excluded). 13. Decompensated right heart failure, as adjudicated by the site PI. 14. Screening HbA1c \>10% with symptoms such as polyuria and polydipsia
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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
3 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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Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195, United States
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The Johns Hopkins Hospital
RECRUITINGBaltimore, Maryland, 21287, United States
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37232, United States
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