COPDNCT01393379
ELVR in PH Patients With Severe Emphysema
An observational study of COPD and Pulmonary Emphysema, run by Heidelberg University at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- COPD, Pulmonary Emphysema
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe emphysema and PH, where ELVR is indicated
Who may be able to join
- 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%
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Center for pulmonary Hypertension, Thoraxclinic Heidelberg
Heidelberg, 69126
About this study
Official title: 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
Read the 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
- Conditions
- COPD, Pulmonary Emphysema
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startApr 2010
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Ekkehard Gruenig, Heidelberg University
- Investigators
- Christoph Corvinus, MD, Principal investigator, Center for pulmonary hypertension, Thoraxclinic Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393379
- Sponsor's protocol ID
- S445/2009
- Status last verified
- Jun 2015
- First submitted
- 12 Jul 2011
- Last updated
- 22 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endoscopic Lung Volume Reduction (ELVR) on Pulmonary Hypertension (PH) in Patients With Severe Emphysema and Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT01393379
- Acronym / sponsor ID
- S445/2009
- Conditions
- COPD, Pulmonary Emphysema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe emphysema and PH, where ELVR is indicated
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Corvinus, MD principal investigator
Center for pulmonary hypertension, Thoraxclinic Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Pulmonary Emphysema, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2015.