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临床试验 NCT05179356 (DAPAH) 针对肺动脉高压，慢性血栓栓塞性肺动脉高压目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
Dapagliflozin in Pulmonary Arterial Hypertension (DAPAH)
Effects of DAPAgliflozin on Cardiopulmonary Exercise Capacity and Hemodynamics in Pulmonary Arterial Hypertension: A Double Blind Randomized Trial. (DAPAH-trial)
- DAPAH
- DAPAH16122021
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照Dapagliflozin 10 mg once daily Dapagliflozin 10 mg (Farxiga 10 mg) given once daily for three months | Dapagliflozin 10 MG [Farxiga] Dapagliflozin 10 mg given once daily for three months |
安慰剂对照Matching placebo Placebo given once daily for three months | 安慰剂 Matching placebo |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in VO2 max from baseline to follow up | 3 months |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 | |
Change in central venous pressure | 3 months | |
Change in transpulmonary gradient | 3 months | |
Change in pulmonary arterial compliance | 3 months | |
Change in right ventricular size on 3D echocardiography | 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 NTproBNP | 3 months | |
Change in EQ-5D-5L questionnaire | 3 months | |
Change in metabolomic pattern on central venous blood | 3 months |
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
Mads Ersbøll