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Dapagliflozin in Pulmonary Arterial Hypertension (DAPAH)
EU CTIS ID: 2024-518551-37-00
What this study is testing
The objective of this study is to evaluate the effects of oral dapagliflozin (Forxiga®) treatment versus placebo in clinically stable patients with PAH on background vasodilator combination therapy on cardiopulmonary exercise capacity, pulmonary vascular hemodynamics, RV function and metabolomic profile of the pulmonary vascular endothelium.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- A diagnosis of PAH group 4 or group 1 in any of the following subtypes: 1) Idiopathic PAH (iPAH), 2) Heritable PAH (hPAH), 3) Connective tissue disease associated PAH (aPAH). In case of PAH 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
You likely can't join if
- Known allergy to the study medication
- Diagnosis of PAH group 2, 3 or 5
- 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)
See the full eligibility criteria
- A diagnosis of PAH group 4 or group 1 in any of the following subtypes: 1) Idiopathic PAH (iPAH), 2) Heritable PAH (hPAH), 3) Connective tissue disease associated PAH (aPAH). In case of PAH 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
- Known allergy to the study medication
- Diagnosis of PAH group 2, 3 or 5
- 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%
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.