Dapagliflozin in Pulmonary Arterial Hypertension

NCT05179356 | Completed Phase 2 DMC

• 1 other identifier: DAPAH16122021
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Arterial Hypertension; Chronic Thromboembolic Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in VO2 max from baseline to follow up

  3 months

Secondary Outcomes (14)

• Change in 6 minutes walking distance

  3 months

• Change in VE/VCO2

  3 months

• Change in pulmonary vascular resistance

  3 months

• Change in mean pulmonary artery pressure

  3 months

• Change in Cardiac index

  3 months

Study Arms (2)

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

Placebo DRUG

Matching placebo

Matching placebo

Dapagliflozin 10 MG [Farxiga] DRUG

Dapagliflozin 10 mg given once daily for three months

Dapagliflozin 10 mg once daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mads Ersbøll: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 5, 2022
• Study Start: January 1, 2023
• Primary Completion: January 13, 2026
• Study Completion: January 13, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)