NCT05179356已完成2 期
Effects of DAPAgliflozin on Cardiopulmonary Exercise Capacity and Hemodynamics in Pulmonary Arterial Hypertension: A Double Blind Randomized Trial. (DAPAH-trial)
Mads Ersbøll1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in VO2 max from baseline to follow up
研究概览
简要总结
The purpose of this study is to investigate the effects of dapagliflozin on exercise capacity and hemodynamics in patients with pulmonary arterial hypertension
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Dapagliflozin 10 mg once daily
Active Comparator
Dapagliflozin 10 mg (Farxiga 10 mg) given once daily for three months
干预措施: Dapagliflozin 10 MG [Farxiga] (Drug)
Matching placebo
Placebo Comparator
Placebo given once daily for three months
干预措施: Placebo (Drug)
结局指标
主要结局
Change in VO2 max from baseline to follow up
时间窗: 3 months
次要结局
- 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 NTproBNP(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 EQ-5D-5L questionnaire(3 months)
研究者
Mads Ersbøll
Medical doctor
Rigshospitalet, Denmark
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Dapagliflozin in Pulmonary Arterial Hypertension (DAPAH)Pulmonary arterial hypertension2024-518551-37-00Rigshospitalet52
招募中
不适用
Effects of Dapagliflozin on Cardiorespiratory Parameters in Heart FailureHeart Failure With Reduced Ejection FractionLeft Ventricle RemodelingSleep ApneaCardiopulmonary Exercise TestHeart FailureNCT05770167Centro Cardiologico Monzino70
招募中
2 期
CAMEO-FONTAN -Dapagliflozin in the Failing Fontan CirculationNCT06762964Mayo Clinic27
已完成
3 期
Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular EventsDiabetes Mellitus, Non-Insulin-DependentHigh Risk for Cardiovascular EventNCT01730534AstraZeneca17,190
已完成
2 期
Dapagliflozin (DAPA) Effects in HFpEFHeart Failure With Preserved Ejection FractionNCT04730947Mayo Clinic38