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

This study is currently recruiting participants.

Verified July 2012 by University of Heidelberg

Sponsor:

Information provided by (Responsible Party):

Prof. Dr. med. Ekkehard Gruenig, University of Heidelberg

ClinicalTrials.gov Identifier:

NCT01393379

First received: July 12, 2011

Last updated: July 2, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 12, 2011

Last Updated Date

July 2, 2012

Start Date ^ICMJE

April 2010

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01393379 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Patients with severe emphysema and PH, where ELVR is indicated

Condition ^ICMJE

COPD
Pulmonary Emphysema

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ralf Eberhardt, MD	+49 (0) 6221 396 8076	ralf.eberhardt@thoraxklinik-heidelberg.de
Contact: Christoph Corvinus, MD	+49 (0)6221 396 8086	christoph.corvinus@thoraxklinik-heidelberg.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01393379

Other Study ID Numbers ^ICMJE

S445/2009

Has Data Monitoring Committee

Responsible Party

Prof. Dr. med. Ekkehard Gruenig, University of Heidelberg

Study Sponsor ^ICMJE

University of Heidelberg

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Christoph Corvinus, MD

Center for pulmonary hypertension, Thoraxclinic Heidelberg

Information Provided By

University of Heidelberg

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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