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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
  Purpose

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


Condition
COPD
Pulmonary Emphysema

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effect of Endoscopic Lung Volume Reduction (ELVR) on Pulmonary Hypertension (PH) in Patients With Severe Emphysema and Pulmonary Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Estimated Enrollment: 10
Study Start Date: April 2010
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

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with severe emphysema and PH, where ELVR is indicated

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393379

Contacts
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

Locations
Germany
Center for pulmonary Hypertension, Thoraxclinic Heidelberg Recruiting
Heidelberg, Germany, 69126
Contact: Christoph Corvinus, MD     +49 (0)6221 396 8086     christoph.corvinus@thoraxklinik-heidelberg.de    
Principal Investigator: Christoph Corvinus, MD            
Sponsors and Collaborators
University of Heidelberg
Investigators
Principal Investigator: Christoph Corvinus, MD Center for pulmonary hypertension, Thoraxclinic Heidelberg
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Ekkehard Gruenig, Prof. Grünig / PD Dr. Eberhardt, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01393379     History of Changes
Other Study ID Numbers: S445/2009
Study First Received: July 12, 2011
Last Updated: July 2, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Hypertension
Hypertension, Pulmonary
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013