ELVR in PH Patients With Severe Emphysema | NCT01393379

Studies
ELVR in PH Patients With Severe Emphysema

NCT01393379

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

Jun 22, 2015Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

COPD
Pulmonary Emphysema

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

May 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jul 12, 2011

First Submission Date that Met QC Criteria

Jul 12, 2011

First Posted Date

Jul 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2015

Last Update Posted Date

Jun 22, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with severe emphysema and PH, where ELVR is indicated

Sampling Method

Probability Sample

Name	Affiliation	Role
Christoph Corvinus, MD	Center for pulmonary hypertension, Thoraxclinic Heidelberg	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Center for pulmonary Hypertension, Thoraxclinic Heidelberg		Heidelberg		69126	Germany

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D011656	Pulmonary Emphysema

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

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