Optimised Management After Balloon Pulmonary Angioplasty in Patients With Chronic Thromboembolic Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 54
- 主要终点
- Difference of endurance time on cycloergometer
研究概览
简要总结
Balloon pulmonary angioplasty (BPA) is a new method of treatment for inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent CTEPH after surgery. BPA improves or even normalises hemodynamic parameters measured during a right heart catheterization. Nevertheless, the vast majority of patients retain dyspnea and impaired exercise capacity despite considerable hemodynamic improvements.
Pulmonary rehabilitation (RHB) can improve symptoms, quality of life and exercise capacity in patients with CTEPH. Unfortunately, access to RHB remains a concern in many countries. Tele-rehabilitation (tRHB) has been shown feasible and effective some cardiac or pulmonary diseases.
This randomized controlled study aims at comparing the effects of tRHB with the effects of simple advices regarding exercising in CTEPH patients with normalized or near-normalized pulmonary hemodynamics after BPA treatment.
详细描述
Chronic thromboembolic pulmonary hypertension (CTEPH) is a complication of pulmonary embolism leading to dyspnea, effort limitation and sometimes right heart failure and death. Balloon pulmonary angioplasty (BPA) is a new method of treatment for inoperable CTEPH or persistent CTEPH after surgery. BPA restores blood flow in the treated areas and improves or even normalises hemodynamic parameters measured during a right heart catheterization. Nevertheless, the vast majority of patients retain dyspnea and impaired exercise capacity after angioplasty procedures.
Exercise training has been demonstrated to alleviate exercise dyspnea and to improve exercise capacity in many chronic cardiopulmonary conditions. Pulmonary rehabilitation (RHB) can improve symptoms, quality of life and exercise capacity in patients with pulmonary vascular disease of different etiologies including CTEPH. Furthermore, RHB does not present any particular risk for CTEPH patients with normalized or near-normalized pulmonary hemodynamics. Unfortunately, access to RHB remains a concern in many countries. Tele-rehabilitation (tRHB) has been shown feasible and effective some cardiac or pulmonary diseases. Our hypothesis is that tRHB may also be effective in CTEPH patients with normalized or near-normalized pulmonary hemodynamics after BPA treatment.
This randomized controlled study aims at comparing the effects of tRHB with the effects of simple advices regarding exercising in CTEPH patients with normalized or near-normalized pulmonary hemodynamics after BPA treatment.
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
- None
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
- •Age > 18 years old
- •Patients who have undergone pulmonary angioplasty for CTEPH (group 4 of the international classification)
- •Patients with a mean pulmonary artery pressure <= 30 mmHg and cardiac output > 2.5 L/min/m2 at the last angioplasty session
- •Patients who had completed an incremental cardiopulmonary exercise test
- •Patients affiliated to the French social security system
- •Patients with signed informed consent
排除标准
- •Patients unable to complete an incremental cardiopulmonary exercise test
- •Patients unable to complete a 6-minutes walking test, 3-minutes chair raising test and a rehabilitation
- •Patient unable, for technical or any other reason, to connect via the Internet for remote monitoring and/or telerehabilitation
- •Patient for whom a refusal to participate in a rehabilitation programme is anticipated
- •Patient who has participated in a rehabilitation programme in the 6 months prior to the date of inclusion
- •Patients referred to in Articles L1121-5 to L1121-8 of the CSP (pregnant women, parturients, nursing mothers, persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care and adults subject to a legal protection measure or unable to express their consent).
结局指标
主要结局
Difference of endurance time on cycloergometer
时间窗: At inclusion and after 3 months
Expressed in seconds and calculated as follow: endurance time after 3 months - endurance time at inclusion The two tests are performed at 80% of the maximum power reached during a maximum incremental effort test (performed before inclusion)
次要结局
- Dyspnea (NYHA scale)(At inclusion, at Month 1, Month 2 and Month 3)
- 3-minutes chair rise test (3-CRT)(At inclusion and at Month 3)
- 6-minutes walking test (6MWT)(At inclusion and at Month 3)
- St George Respiratory Questionnaire (SGRQ)(At inclusion and at Month 3)
- Telerehabilitation(Through study completion, an average of 3 months)
- SF-36(At inclusion and at Month 3)
- Dyspnea (mMRC score)(At inclusion, at Month 1, Month 2 and Month 3)