Clinical Trials

Dapagliflozin in Pulmonary Arterial Hypertension

Study Purpose

The purpose of this study is to investigate the effects of dapagliflozin on exercise capacity and hemodynamics in patients with pulmonary arterial hypertension

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05179356
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mads Ersbøll
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Denmark
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension

Additional Details

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

Arms

Active Comparator: Dapagliflozin 10 mg once daily

Dapagliflozin 10 mg (Farxiga 10 mg) given once daily for three months

Placebo Comparator: Matching placebo

Placebo given once daily for three months

Interventions

Drug: - Dapagliflozin 10 MG [Farxiga]

Dapagliflozin 10 mg given once daily for three months

Drug: - Placebo

Matching placebo

Contact a Trial Team

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