Effect of Endoscopic Lung Volume Reduction (ELVR) on Pulmonary Hypertension (PH) in Patients With Severe Emphysema and Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to investigate the effect of endoscopic valve implantation in patients with COPD and PH on hemodynamics, symptoms, exercise tolerance and quality of life in 10 patients in a prospective study. An improvement of objective parameters may also have a prognostic significance
详细描述
So far there is no treatment of COPD in addition to the established treatment of concomitant PH. Administration of PH-specific medication outside of clinical trials is not recommended in new guidelines for PH of the ERS/ESC. The influence of endobronchial valve implantation on the PH has not been studied in detail. The purpose of this study is to investigate the effect of endoscopic valve implantation in patients with COPD and PH on hemodynamics, symptoms, exercise tolerance and quality of life in 10 patients in a prospective study. An improvement of objective parameters may also have a prognostic significance
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed patient consent form
- •men and women >30 years
- •Clinically indicated endoscopic lung volume reduction
- •Pulmonary hypertension according to Group 3.1 of the Dana Point classification
- •Severe pulmonary emphysema
- •FEV1 <45%
- •RV> 150%
- •TLC> 100%
- •Maximum of medical therapy according to GOLD
- •heterogeneous emphysema
- •Detected in the HR-CT
- •Confirmation of the heterogeneity of emphysema by computer-assisted quantification (YACTA ®)
- •stable COPD
- •No exacerbation in the last 8 weeks
- •Cortisone dose <20 mg prednisolone equivalent
- •Non-or ex-smoker
- •Nicotine abstinence> 4 months
- •Actual CoHb <2.5%
- •Diagnosis of pulmonary hypertension (PH), invasively diagnosed by right heart catheterization:
- •Mean pulmonary arterial pressure (mPAP)> 25 mmHg
- •Pulmonary capillary wedge pressure (PCWP) <15 mmHg
- •Pulmonary vascular resistance (PVR)> 320 dyne * sec * cm-5
排除标准
- •PH of Group 1, 2, 4, 5 of the Dana Point Classification
- •Previous operations
- •s/p Lung resection (lobectomy / pneumonectomy)
- •s/p endoscopic lung volume resection
- •significant bronchiectasis
- •Sputum volume> 4 tablespoons / day
- •Severe cardiac comorbidities:
- •s/p myocardial infarction in the last 6 weeks
- •Congestive heart failure
- •Cardiomyopathy with highly impaired LVF
- •Clopidogrel in long-term medication
- •Respiratory insufficiency: PaCO2 mmHg at rest> 55
- •current pregnancy
研究者
Prof. Dr. med. Ekkehard Gruenig
Prof. Grünig / PD Dr. Eberhardt
Heidelberg University