ELVR in PH Patients With Severe Emphysema

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Pulmonary Emphysema Respiratory Tract Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for pulmonary Hypertension, Thoraxclinic Heidelberg

Heidelberg, 69126, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Jul 13, 2011
Registry last updated: Jun 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed