Could a common diabetes pill help people with rare lung disease breathe easier?
NCT ID NCT05179356
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested the drug dapagliflozin (used for diabetes and heart failure) in 52 adults with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension. The goal was to see if it improves exercise capacity and heart function. Participants took the drug or a placebo for a period, then had tests like exercise stress and heart catheterization. The study is complete, and results will show if this drug can help manage the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
52 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Jan 2026
- 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
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * A diagnosis of PAH group 4 or group 1 in any of the following subtypes: * Idiopathic PAH (iPAH) * Heritable PAH (hPAH) * Connective tissue disease associated PAH (aPAH) * Associated with congenital heart disease (aPAH) * In case of PH in group 4, no further invasive treatment including pulmonary endarterectomy or pulmonary balloon angioplasty must be planned at time of inclusion. * Symptomatic PAH in WHO functional class II-III as assessed by the screening clinician. * Clinically stable patients on pulmonary vasodilator treatment with PDE5i, ERA, PA/IPA alone or in combination without considerations from the treating physician team towards treatment escalation and a treatment duration of at least four weeks. Clinical stability defined as stable symptoms without progression as assessed by treating clinician and without the need for unplanned hospital admissions due to worsening PAH within three months of screening. * Fertile women (\< 50 years of age) must use safe contraceptives (Intra uterine device or hormonal contraception) for the duration of the study and have a negative pregnancy test * Able to understand the written patient information in Danish and give informed consent. * Age ≥ 18 years * Ability to perform cardio pulmonary exercise test Exclusion Criteria: * Known allergy to the study medication * Treatment with an SGLT2i within 6 months prior to baseline * Type 1 or type 2 diabetes * Impaired renal function with an eGFR \< 30 mL/min/m2 within four weeks of screening * Severe liver dysfunction (Child-Pugh class c) * Listed for lung transplantation at the time of screening * Planned initiation of iv prostacyclin therapy/ IPA or current dose escalation planned * Planned pulmonary endarterectomy or pulmonary balloon angioplasty. * LVEF \< 50% * Diagnosis of PAH group 2, 3 or 5
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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.
Contacts and locations
Locations
-
Rigshospitalet
Copenhagen, 2100, Denmark
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Other studies related to the condition(s) this trial covers.
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