Pulmonary Arterial HypertensionPhase 2DAPAHNCT05179356
Dapagliflozin in Pulmonary Arterial Hypertension
A Phase 2 study testing Dapagliflozin 10 MG [Farxiga] in people with Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension, run by Mads Ersbøll at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the effects of dapagliflozin on exercise capacity and hemodynamics in patients with pulmonary arterial hypertension Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Dapagliflozin 10 MG [Farxiga]
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2023to 13 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of DAPAgliflozin on Cardiopulmonary Exercise Capacity and Hemodynamics in Pulmonary Arterial Hypertension: A Double Blind Randomized Trial. (DAPAH-trial)
The purpose of this study is to investigate the effects of dapagliflozin on exercise capacity and hemodynamics in patients with pulmonary arterial hypertension
Read the detailed description
The objective of this study is to evaluate the effects of oral dapagliflozin (Forxiga®) treatment versus placebo in clinically stable patients with pulmonary arterial hypertension or CTEPH on background vasodilator combination therapy on cardio-pulmonary exercise capacity, pulmonary vascular hemodynamics, RV function and metabolomic profile of the pulmonary vascular endothelium.
- Being tested
- Dapagliflozin 10 MG [Farxiga], Placebo
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 MG [Farxiga]Drug
Dapagliflozin 10 mg given once daily for three months
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 10 mg once daily | Active comparator | Dapagliflozin 10 mg (Farxiga 10 mg) given once daily for three months Receives: Drug: Dapagliflozin 10 MG [Farxiga] |
| Matching placebo | Placebo comparator | Placebo given once daily for three months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VO2 max from baseline to follow up
Measured: 3 months
Secondary outcomes (14)
Change in 6 minutes walking distance
Measured: 3 months
Change in VE/VCO2
Measured: 3 months
Change in pulmonary vascular resistance
Measured: 3 months
Change in mean pulmonary artery pressure
Measured: 3 months
Change in Cardiac index
Measured: 3 months
Change in central venous pressure
Measured: 3 months
Change in transpulmonary gradient
Measured: 3 months
Change in pulmonary arterial compliance
Measured: 3 months
Change in right ventricular size on 3D echocardiography
Measured: 3 months
Change in right ventricular free wall strain
Measured: 3 months
Change in right ventricular free wall strain-work (free wall strain/ pulmonary artery pressure)
Measured: 3 months
Change in NTproBNP
Measured: 3 months
Change in EQ-5D-5L questionnaire
Measured: 3 months
Change in metabolomic pattern on central venous blood
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Jan 2023
- Primary completion13 Jan 2026
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mads Ersbøll
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mads Ersbøll, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179356
- Sponsor's protocol ID
- DAPAH16122021
- Acronym
- DAPAH
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2021
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ersboll MK, Kjaergaard J, Waidtlow K, Kober L, Gustafsson F, Kiely DG, Montani D, Carlsen J, Rossing K. Dapagliflozin in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension: The DAPAH randomized controlled trial. J Heart Lung Transplant. 2026 Aug 31:S1053-2498(26)01987-X. doi: 10.1016/j.healun.2026.07.008. Online ahead of print.
PubMed 42671364
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of DAPAgliflozin on Cardiopulmonary Exercise Capacity and Hemodynamics in Pulmonary Arterial Hypertension: A Double Blind Randomized Trial. (DAPAH-trial)
- ClinicalTrials.gov ID
- NCT05179356
- Acronym / sponsor ID
- DAPAH / DAPAH16122021
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Mads ErsbøllUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effects of dapagliflozin on exercise capacity and hemodynamics in patients with pulmonary arterial hypertension
Detailed description
The objective of this study is to evaluate the effects of oral dapagliflozin (Forxiga®) treatment versus placebo in clinically stable patients with pulmonary arterial hypertension or CTEPH on background vasodilator combination therapy on cardio-pulmonary exercise capacity, pulmonary vascular hemodynamics, RV function and metabolomic profile of the pulmonary vascular endothelium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 10 mg once daily | Active comparator | Drug: Dapagliflozin 10 MG [Farxiga]Dapagliflozin 10 mg (Farxiga 10 mg) given once daily for three months |
| Matching placebo | Placebo comparator | Drug: PlaceboPlacebo given once daily for three months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- A diagnosis of PAH group 4 or group 1 in any of the following subtypes:
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10 MG [Farxiga]Dapagliflozin 10 mg given once daily for three months | Drug | Dapagliflozin 10 mg once daily |
| PlaceboMatching placebo | Drug | Matching placebo |
Primary outcome
Change in VO2 max from baseline to follow up
Time frame: 3 months
14 secondary outcomes
Change in 6 minutes walking distance
Time frame: 3 months
Change in VE/VCO2
Time frame: 3 months
Change in pulmonary vascular resistance
Time frame: 3 months
Change in mean pulmonary artery pressure
Time frame: 3 months
Change in Cardiac index
Time frame: 3 months
Change in central venous pressure
Time frame: 3 months
Change in transpulmonary gradient
Time frame: 3 months
Change in pulmonary arterial compliance
Time frame: 3 months
Change in right ventricular size on 3D echocardiography
Time frame: 3 months
Change in right ventricular free wall strain
Time frame: 3 months
Change in right ventricular free wall strain-work (free wall strain/ pulmonary artery pressure)
Time frame: 3 months
Change in NTproBNP
Time frame: 3 months
Change in EQ-5D-5L questionnaire
Time frame: 3 months
Change in metabolomic pattern on central venous blood
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Derived from this study: PubMed 42671364Ersboll MK, Kjaergaard J, Waidtlow K, Kober L, Gustafsson F, Kiely DG, Montani D, Carlsen J, Rossing K. Dapagliflozin in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension: The DAPAH randomized controlled trial. J Heart Lung Transplant. 2026 Aug 31:S1053-2498(26)01987-X. doi: 10.1016/j.healun.2026.07.008. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin 10 MG [Farxiga] in people with Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension, run by Mads Ersbøll at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VO2 max from baseline to follow up (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05179356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.