ELVR in PH Patients With Severe Emphysema

Completed

• Conditions: COPD; Pulmonary Emphysema

• Registration Number: NCT01393379
• Lead Sponsor: Heidelberg University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2011-07-12
• Study First Posted: 2011-07-13
• Primary Completion: 2014-05
• Study Completion: 2014-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-19
• Last Update Posted: 2015-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Center for pulmonary Hypertension, Thoraxclinic Heidelberg; 🇩🇪 Heidelberg, Germany