ELVR in PH Patients With Severe Emphysema

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

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 Overview

• Status: Completed
• Conditions: Pulmonary Emphysema; COPD

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: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69126
    • Center for pulmonary Hypertension, Thoraxclinic Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with severe emphysema and PH, where ELVR is indicated

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: Heidelberg University
• Investigators: Principal Investigator: Christoph Corvinus, MD, Center for pulmonary Hypertension, Thoraxclinic Heidelberg

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 12, 2011
• First Submitted That Met QC Criteria: July 12, 2011
• First Posted (Estimate): July 13, 2011

Study Record Updates

• Last Update Posted (Estimate): June 22, 2015
• Last Update Submitted That Met QC Criteria: June 19, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: S445/2009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No