Hemodynamic Study of the Pulmonary Circulation in Exercise in Patients With Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in total pulmonary resistance (TPR) from rest to exercise
研究概览
简要总结
The study evaluates the rest and exercise hemodynamics of patients presenting either idiopathic fibrotic pulmonary disease or pulmonary fibrosis secondary to connective tissue disease.
详细描述
Patients with fibrotic pulmonary disease of the above origin will undergo detailed assessment of functional status with the following examinations: pulmonary function tests, echocardiogram, 6 minute exercise test, cardiopulmonary exercise test (in the absence of contra-indications) and finally right heart catheterization. Hemodynamic assessment will take place at rest and at exercise following the exercise protocol that was recommended by Herve et al (ERJ 2015) using a cycle ergometer at bedside.
The purposes of the study are:
- to evaluate the response of the hemodynamic parameters at exercise compared to the resting parameters in this patient group.
- to discriminate between precapillary from postcapillary etiology of pulmonary hypertension.
- to correlate non-invasive parameters of functional limitation with invasive hemodynamic parameters.
- to assess the prognostic role of exercise induced pulmonary hypertension in the specific patient group.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of pulmonary fibrosis secondary to connective tissue disease, according to the American College of Rheumatology/European League Against Rheumatism (ACR-EULAR) revised classification criteria , or diagnosis of idiopathic fibrotic diffuse pulmonary disease according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
- •Forced vital capacity (FVC) ≥ 40 %
排除标准
- •Presence of contra-indications to exercise tests, such as acute myocardial infarction, unstable angina, uncontrollable arrythmia or skeletal disease that limits the ability to exercise.
- •History of pulmonary embolism during the year before enrollment
- •Presence of severe valvular disease.
- •Current treatment with vasoactive drugs of the pulmonary circulation
- •Pulmonary wedge pressure (PAWP) at rest > 15 mmHg
结局指标
主要结局
Change in total pulmonary resistance (TPR) from rest to exercise
时间窗: 2nd minute,4th minute, 6th minute, 8th minute
The patient undergoes right heart catheterization and all hemodynamic variables are measured at rest and at exercise. TPR is derived by the following equation : mean pulmonary artery pressure/ cardiac output (mPAP/CO). TPR is measured at rest and at exercise following a specific protocol. The measurements are made at rest, then at the sequential exercise steps of increasing work resistance.
次要结局
未报告次要终点
研究者
EVAGGELIA PANAGIOTIDOU
Phd candidate, Resident of Pulmonary medicine, G.H.G.Papanikolaou, Thessaloniki, Greece
Aristotle University Of Thessaloniki