Impact of Lung Hyperinflation on the Response to Pulmonary Vasodilator Therapy in Patients with Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Response to treatment
研究概览
简要总结
The goal of this retrospective observational study is to evaluate if lung distension disorders can be a predictive factor of bad response to vasodilator therapy in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD).
The study will include all patients from the hospital, followed for pulmonary hypertension associated with COPD under vasodilator therapy between 2015 and 2021.
详细描述
The goal of this retrospective observational study is to evaluate if lung distension disorders can be a predictive factor of bad response to vasodilator therapy in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD).
The study will include all patients from the hospital, followed for PH associated with COPD under vasodilator therapy between 2015 and 2021.
It will evaluate patients' lung hyperinflation according to the RV/TLC ratio and their response to treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Patients with COPD regardless of severity defined as a FEV1/FVC ratio less than 0.70 and the presence of a risk factor (smoke exposure with at least a 10 pack-year history, or professional exposition) diagnosed with PH according to ESC/ERS 2022 classification and in whom vasodilator therapy has been initiated
排除标准
- •other known concomitant lung disease (interstitial lung disease, cystic lung disease, mucoviscidosis...)
- •thoracic pathology such as kyphoscoliosis
- •pleural effusion (unless part of pulmonary veno-occlusive disease)
- •a large tumor lung mass
- •EFR missing or uninterpretable because difficult to perform
- •initiation of calcium channel blockers
- •surgical treatment in chronic thrombo-embolic pulmonary hypertension
- •no follow-up evaluation (lost to follow-up or died before reassessment)
结局指标
主要结局
Response to treatment
时间窗: 3 - 12 months
Response to treatment is defined as an improvement of at least 30 meters in the 6-minute walk test or one NYHA functional class at the first re-evaluation performed at least 3 months after the initiation of vasodilator therapy. These criteria will be compared according to the severity of chest distension.
次要结局
未报告次要终点