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Effects of DAPAgliflozin on cardiopulmonary exercise capacity and hemodynamics in Pulmonary Arterial Hypertension: A double blind randomized trial. (DAPAH-trial)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518551-37-00
Enrollment
52
Registered
2024-10-23
Start date
2023-01-01
Completion date
2026-01-13
Last updated
2024-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic thromboembolic pulmonary hypertension, Pulmonary arterial hypertension

Brief summary

Change in maximum oxygen consumption (VO2 max) measured by cardiopulmonary exercise testing from baseline to follow up after ninety days between dapagliflozin and placebo

Detailed description

Change in 6-minute walking distance (6MWD) from baseline to follow up after three months, Change in VE/VCO2 from baseline to follow up after ninety days, Change in mean pulmonary artery pressure (meanPAP) from baseline to follow up after ninety days, Change in cardiac index (CI) and pulmonary vascular resistance (PVR) from baseline to follow up after ninety days, Change in central venous pressure (CVP) from baseline to follow up after ninety days, Change in transpulmonary gradient from baseline to follow up after ninety days, Change in pulmonary arterial compliance (sysPAP/strokevolume) from baseline to follow up after ninety days, Change in right ventricular (RV) size as assessed by 3D echocardiography from baseline to follow up after ninety days, Change in right ventricular (RV) free wall strain from baseline to follow up after three months, Change in right ventricular (RV) free wall strain-work (RV-LS / meanPAP) from baseline to follow up after ninety days, Change in plasma NT-proBNP from baseline to follow up after ninety days, Change in EQ-5D-5L questionnaire from baseline to follow up after ninety days, Change in metabolomic and proteomic patterns from baseline to follow up after three months, Changes in selected biomarkers, se section on biomarkers from baseline to follow up after ninety days

Interventions

DRUGPLACEBO
DRUGForxiga 10 mg film-coated tablets

Sponsors

Rigshospitalet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in maximum oxygen consumption (VO2 max) measured by cardiopulmonary exercise testing from baseline to follow up after ninety days between dapagliflozin and placebo

Secondary

MeasureTime frame
Change in 6-minute walking distance (6MWD) from baseline to follow up after three months, Change in VE/VCO2 from baseline to follow up after ninety days, Change in mean pulmonary artery pressure (meanPAP) from baseline to follow up after ninety days, Change in cardiac index (CI) and pulmonary vascular resistance (PVR) from baseline to follow up after ninety days, Change in central venous pressure (CVP) from baseline to follow up after ninety days, Change in transpulmonary gradient from baseline to follow up after ninety days, Change in pulmonary arterial compliance (sysPAP/strokevolume) from baseline to follow up after ninety days, Change in right ventricular (RV) size as assessed by 3D echocardiography from baseline to follow up after ninety days, Change in right ventricular (RV) free wall strain from baseline to follow up after three months, Change in right ventricular (RV) free wall strain-work (RV-LS / meanPAP) from baseline to follow up after ninety days, Change in plasma NT-proBN

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026