Screening for Pulmonary Vascular Changes in Patients With Chronic Myeloproliferative Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- pulmonary arterial pressure
研究概览
简要总结
Goal of the study is to assess the frequency of pulmonary hypertension in patients with chronic myeloproliferative diseases. In each patient an echocardiography at rest will be performed. In patients without musculoskeletal disease an exercise test (spiroergometry) will be performed. Patients with elevated SPAP at rest or with reduced exercise capacity (peak VO2 < 65%) a right heart catheterization (RHC) will be recommended. Also patients with advanced NYHA functional class (III or IV) or with typical PH findings in electrocardiogram will be advised to undergo a RHC. Additionally for the evaluation of exercise capacity a 6 MWD will be performed.
This work- up of patients allows clinical and hemodynamic evaluation.
详细描述
Previous small studies and clinical cases have suggested a possible association between pulmonary hypertension (PH) and chronic myeloproliferative disorders (CMPD). MPD may cause PH through different mechanisms as: high cardiac output, asplenia, direct obstruction of pulmonary arteries by megakaryocytes, chronic thromboembolic endothelial pulmonary hypertension (CTEPH), porto-pulmonary hypertension (POPH). However, the exact prevalence of PH in this group of disorders is not known.
This study is designed to identify the pulmonary vascular changes and describe the prevalence of pulmonary hypertension (defined in this study as mean pulmonary arterial hypertension (mPAP) ≥25mmHg as assessed by right-heart catheterization (RHC) or systolic pulmonary arterial pressure (sPAP) ≥37mmHg (2.9 m/s) assessed by echocardiography.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with myeloproliferative disorders
- •Written informed consent
排除标准
- •Manifest pulmonary hypertension
- •Significant pulmonary disease
- •Left-sided heart failure or diastolic compliance dysfunction
- •Hemodynamic relevant valvular disease
- •Systemic arterial hypertension (at rest systolic >150 mmHg, diastolic > 90 mmHg, during exercise > 220 mmHg)
- •Severe anemia
- •Uncontrolled supraventricular and ventricular arrhythmias
- •Myocardial infarction (within the last 12 months)
- •Pulmonary embolism (within the last 12 months)
- •Recent therapy changes (within the last 12 months)
- •Recent major surgeries (within the last 12 months)
- •For exercise tests: musculoskeletal diseases which may unable the exercise tests
结局指标
主要结局
pulmonary arterial pressure
时间窗: at baseline
次要结局
- change of pulmonary arterial pressure(between baseline and after 6 months)