Balloon Pulmonary anGiOplasty Versus Pulmonary Endarterectomy in Patients With Chronic ThromboEmbolic Pulmonary Hypertension: a Non-inferiority Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Change in pulmonary vascular resistance
研究概览
简要总结
Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare and potentially life-threatening progressive disease that evolves from unresolved pulmonary embolism. Gold standard treatment for CTEPH is pulmonary endarterectomy (PEA) performed by skilled cardio-thoracic surgeons.
Some patients may not be surgical candidates due to co-morbidities or because the vascular lesions are too distal making them technically inoperable. In these patients, balloon pulmonary angioplasty (BPA) has emerged as an effective treatment. In a subgroup of patients, the distribution of vascular lesions makes it possible to perform either BPA or PEA. There has never been a head-to head comparison of BPA with PEA. The aim of this study is therefore, to evaluate if BPA is non-inferior to PEA in patients with (CTEPH) who are eligible for both treatments.
详细描述
An investigator-initiated multicenter, prospective, randomized, controlled, open label, non-inferiority trial. The study will randomize (1:1) 152 patients with CTEPH who are eligible for both PEA and BPA. Patients will be screened for study inclusion at the local CTEPH multidisciplinary team conference and eligibility for both PEA and BPA will be confirmed by a central adjudication committee.
PEA or BPA will be completed within 6 months from randomization. Follow-up visit with right heart catheterization will be completed at 4 months and 12 months after PEA or last BPA session.
Primary end-point is change in pulmonary vascular resistance from baseline to 4 months and 12 months after PEA or the last BPA session.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with chronic thromboembolic pulmonary hypertension according to current European society of cardiology/European Respiratory Society guidelines and eligible for both pulmonary endarterectomy and ballon pulmonary angioplasty by decision at the local multidisciplinary team conference and central adjudication committee
- •Written informed consent from the patient
- •Patient age >17 and <80 years
- •Able to understand and follow instructions and to participate in the entire study period
排除标准
- •Life expectancy <12 months
- •Co morbidities evaluated at the multidisciplinary team conference, that contributes significantly to the patients pulmonary hypertension
- •Not possible to perform balloon pulmonary angioplasty or pulmonary endarterectomy within 4 months after randomization.
- •Evaluated at multidisciplinary team conference that changes in pulmonary artery hypertension targeted therapy between baseline and 4 months follow-up is inevitable*
- •Known pregnancy or positive urine Human chorionic gonadotropin screening test in fertile women
- •Previous balloon pulmonary angioplasty or pulmonary endarterectomy
结局指标
主要结局
Change in pulmonary vascular resistance
时间窗: 4 months and 12 months
Change in pulmonary vascular resistance from baseline to 4-months and 12-months after the procedure(s). Patients on medical treatments at baseline will remain on medical treatments until the assessment of the primary endpoint, and be taken off if hemodynamics permit
次要结局
- Six minutes walking distance(4 months and 12 months)
- Cardiac index(4 months and 12 months)
- Mean right atrial pressure(4 months and 12 months)
- Time to clinical worsening(4 months and 12 months)
- Quality of life evaluated by the "Living with pulmonary hypertension questionnaire"(4 months and 12 months)
- Mean pulmonary artery pressure(4 months and 12 months)
- N-terminal pro B-type natriuretic peptide(4 months and 12 months)