TrEatment Approach in the Multimodal Era Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 25
- 主要终点
- 3-year survival
研究概览
简要总结
The goal of this observational patient registry is to learn how expert centers treat patients with chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH is a condition in which blood clots block the blood vessels in the lungs. There are currently three treatment options for patients with CTEPH:
- surgery to remove blood clots from large vessels in the lungs (pulmonary endarterectomy (PEA))
- the use of a small balloon to unblock smaller blood vessels (balloon pulmonary angioplasty (BPA))
- drugs
Patients can also receive a combination of these treatments.
The main question this registry aims to answer are:
- How many patients receive a given kind of treatment?
- How do expert centers combine the different treatments?
- Are patients doing better after they receive a given kind of treatment?
- How many patients are alive 1, 3 and 5 years after they receive a given kind of treatment?
Participants will receive the same treatments that they would receive if they did not participate in the study. During the study, patients will visit their doctors as they would do normally. The doctors will collect information on the patients' health and enter it into the study database. The follow-up time will be at least 3 years for all patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Newly referred patient with CTEPH or chronic thromboembolic pulmonary disease (CTEPD) without PH according to the following criteria:
- •Mean pulmonary arterial pressure (mPAP) > 20 mmHg at rest with pulmonary vascular resistance (PVR) > 2 Wood units (WU); or if mPAP ≤ 20 mmHg or PVR ≤ 2 WU at rest, have exercise limitations from CTEPD without PH
- •Abnormal ventilation perfusion scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming CTEPD as recommended by standard guidelines
- •Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH or CTEPD without PH
- •Naïve to interventional treatment (both PEA and BPA)
- •Pre-treatment with PH-specific medication for ≤ 12 months, or no medical pre-treatment, at enrollment
- •Willing and able to provide informed consent in order to participate in the study (informed consent signed)
- •Age ≥ 18 years
- •CTEPH-specific treatment must be modified or initiated at the participating site
排除标准
- •Main cause of PH other than CTEPH
- •Participating in an interventional clinical trial at enrollment
结局指标
主要结局
3-year survival
时间窗: 3 years after last intervention
Proportion of patients alive 3 years after the last intervention recorded in the registry, or after start of medical treatment for patients not undergoing any interventional treatment
Utilization and combination of treatment modalities
时间窗: Min. 3 years
Proportion of patients undergoing a certain type of treatment modality, or a certain combination of modalities
次要结局
- Reason why PEA was not performed(Min. 3 years)
- 1-year survival(1 year after last intervention)
- Changes in PH-specific medication(Min. 3 years)
- Reason why BPA was not performed(Min. 3 years)
- Complications of treatment interventions (per patient)(Min. 3 years)
- Complications of treatment interventions (per BPA session)(Min. 3 years)
- 5-year survival(5 year after last intervention)