The purpose of this study is to investigate the effects of dapagliflozin on exercise capacity and hemodynamics in patients with pulmonary arterial hypertension
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
Dapagliflozin 10 mg given once daily for three months
Matching placebo
Rigshospitalet
Copenhagen, Denmark
Change in VO2 max from baseline to follow up
Time frame: 3 months
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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