Dapagliflozin in Pulmonary Arterial Hypertension
- Conditions
- Chronic Thromboembolic Pulmonary HypertensionPulmonary Arterial Hypertension
- Interventions
- Drug: Dapagliflozin 10 MG [Farxiga]Drug: Placebo
- Registration Number
- NCT05179356
- Lead Sponsor
- Mads Ersbøll
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 52
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dapagliflozin 10 mg once daily Dapagliflozin 10 MG [Farxiga] Dapagliflozin 10 mg (Farxiga 10 mg) given once daily for three months Matching placebo Placebo Placebo given once daily for three months
- Primary Outcome Measures
Name Time Method Change in VO2 max from baseline to follow up 3 months
- Secondary Outcome Measures
Name Time Method Change in NTproBNP 3 months Change in right ventricular size on 3D echocardiography 3 months Change in 6 minutes walking distance 3 months Change in Cardiac index 3 months Change in right ventricular free wall strain 3 months Change in right ventricular free wall strain-work (free wall strain/ pulmonary artery pressure) 3 months Change in VE/VCO2 3 months Change in pulmonary vascular resistance 3 months Change in metabolomic pattern on central venous blood 3 months Change in mean pulmonary artery pressure 3 months Change in central venous pressure 3 months Change in transpulmonary gradient 3 months Change in pulmonary arterial compliance 3 months Change in EQ-5D-5L questionnaire 3 months
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen, Denmark