ELVR in PH Patients With Severe Emphysema

COPD Clinical Trial

Official title:

Effect of Endoscopic Lung Volume Reduction (ELVR) on Pulmonary Hypertension (PH) in Patients With Severe Emphysema and Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01393379
• Other study ID #: S445/2009
• Status: Completed
• Phase: N/A
• First received: July 12, 2011
• Last updated: June 19, 2015
• Start date: April 2010
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD
• Emphysema
• Pulmonary Emphysema

Locations

Country	Name	City	State
Germany	Center for pulmonary Hypertension, Thoraxclinic Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany,