Dapagliflozin in Pulmonary Arterial Hypertension | NCT05179356

Studies
Dapagliflozin in Pulmonary Arterial Hypertension

NCT05179356

Sponsor

Mads Ersbøll

Status

Completed

Last Update Posted

Jan 21, 2026Actual

Enrollment

52Actual

Phase

Phase 2

Conditions

Pulmonary Arterial Hypertension
Chronic Thromboembolic Pulmonary Hypertension

Interventions

Dapagliflozin 10 MG [Farxiga]
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jan 13, 2026Actual

Completion Date

Jan 13, 2026Actual

First Submitted Date

Dec 16, 2021

First Submission Date that Met QC Criteria

Dec 16, 2021

First Posted Date

Jan 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2026

Last Update Posted Date

Jan 21, 2026Actual

Description Module

Brief Summary

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dapagliflozin 10 mg once daily	Active Comparator	Dapagliflozin 10 mg (Farxiga 10 mg) given once daily for three months	Drug: Dapagliflozin 10 MG [Farxiga]
Matching placebo	Placebo Comparator	Placebo given once daily for three months	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dapagliflozin 10 MG [Farxiga]	Drug	Dapagliflozin 10 mg given once daily for three months	Dapagliflozin 10 mg once daily

Measure	Description	Time Frame
Change in VO2 max from baseline to follow up		3 months

Measure	Description	Time Frame
Change in 6 minutes walking distance		3 months
Change in VE/VCO2		3 months
Change in pulmonary vascular resistance

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases