NCT01393379

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 22, 2015

Status Verified

June 1, 2015

Enrollment Period

4.1 years

First QC Date

July 12, 2011

Last Update Submit

June 19, 2015

Conditions

COPDPulmonary Emphysema

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with severe emphysema and PH, where ELVR is indicated

You may qualify if:

  • 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
  • +7 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for pulmonary Hypertension, Thoraxclinic Heidelberg

Heidelberg, 69126, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructivePulmonary Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christoph Corvinus, MD

    Center for pulmonary hypertension, Thoraxclinic Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Grünig / PD Dr. Eberhardt

Study Record Dates

First Submitted

July 12, 2011

First Posted

July 13, 2011

Study Start

April 1, 2010

Primary Completion

May 1, 2014

Study Completion

December 1, 2014

Last Updated

June 22, 2015

Record last verified: 2015-06

Locations

DE(1)