Clinical trial NCT01393379: ELVR in PH Patients With Severe Emphysema
Official title: Effect of Endoscopic Lung Volume Reduction (ELVR) on Pulmonary Hypertension (PH) in Patients With Severe Emphysema and Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Pulmonary Emphysema
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe emphysema and PH, where ELVR is indicated

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

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Center for pulmonary Hypertension, Thoraxclinic Heidelberg
Study officials:
affiliation: Center for pulmonary hypertension, Thoraxclinic Heidelberg
name: Christoph Corvinus, MD
role: PRINCIPAL_INVESTIGATOR
References: