Effects of dapagliflozin on pulmonary arterial hypertension
Effects of DAPAgliflozin on Cardiopulmonary Exercise Capacity and Hemodynamics in Pulmonary Arterial Hypertension: A Double Blind Randomized Trial. (DAPAH-trial)
This study is testing if the medication dapagliflozin can improve exercise ability and heart function in people with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05179356 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of dapagliflozin, an oral medication, on exercise capacity and hemodynamics in patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH). Participants will receive either dapagliflozin or a placebo while on stable background vasodilator therapy. The study aims to assess changes in cardio-pulmonary exercise capacity, pulmonary vascular hemodynamics, right ventricular function, and the metabolomic profile of the pulmonary vascular endothelium. It targets clinically stable patients with specific subtypes of PAH.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with PAH or CTEPH who are clinically stable and on background vasodilator therapy.
Not a fit: Patients who are not clinically stable or those requiring immediate invasive treatments for their condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve exercise capacity and overall cardiovascular health in patients with pulmonary arterial hypertension.
How similar studies have performed: While there is ongoing research in this area, the specific use of dapagliflozin for PAH is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Mads Ersbøll, MD, PhD
- Email: mads.kristian.ersboell.02@regionh.dk
- Phone: +45 35453580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.