Pulmonary HypertensionNCT02778802
Pulmonary Hemodynamics in Patients With Severe Emphysema Pre and Post BLVR
An observational study of Pulmonary Hypertension and Chronic Obstructive Lung Disease, run by Cairo University at 1 site in Egypt.
Trial summary
This study is designed as a prospective study, with the primary endpoint being changes in pulmonary hemodynamic parameters after ELVR in patients with severe emphysema. Secondary endpoints will be changes in lung function parameters, exercise capacity, and QoL. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Pulmonary Hypertension, Chronic Obstructive Lung Disease
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2016to May 2017
- 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: COPD Patients with predominant emphysema especially with heterogeneous and upper lobe predominance emphysema
Who may be able to join
- COPD patients with predominant emphysema especially with heterogeneous and upper lobe predominance emphysema
Who cannot join
- Airflow limitation with FEV1 < 20%.
- Patients not candidate for FOB.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alaini School of Medicine
Cairo, 14211
Mostafa I Elshazly, MD, 00201001272020, elshazly66@hotmail.com
Mostafa Elshazly, MD
About this study
Official title: Pulmonary Hemodynamics in Patients With Severe Emphysema Pre and Post Bronchoscopic Volume Reduction by Histoacryl or Silver Nitrate (Single Center Experince )
This study is designed as a prospective study, with the primary endpoint being changes in pulmonary hemodynamic parameters after ELVR in patients with severe emphysema.
Secondary endpoints will be changes in lung function parameters, exercise capacity, and QoL.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) continues to be a leading cause of morbidity and is currently the third most common cause of mortality worldwide (1).
In most patients with severe COPD, chronic airflow limitation, lung emphysema with parenchymal destruction and the development of air bullae also occur (2-3) Pulmonary hypertension (PH) is a common consequence of COPD, although the actual overall prevalence of PH in COPD remains unclear (4). Among COPD patients who were to undergo lung-volume-reduction surgery or lung transplantation, mild PH was observed in 50.2%, moderate PH in 9.8%, and severe PH in 3.7%(5). While in most COPD patients who develop PH, pulmonary arterial pressure is only mildly or moderately elevated, (6) PH has an independent prognostic impact on survival. (6,7) The therapeutic options for COPD patients with severe emphysema are limited. Lung volume reduction surgery (LVRS) has been performed as treatment in selected cases, but the referral of patients has been severely influenced by the marked perioperative morbidity and mortality [8]. Less invasive techniques have been developed with the aim of improving patients' pulmonary function, symptoms, and quality of life (QoL) [9]. Among them, the one most commonly used is the endoscopic placement of one way endobronchial valves (EBV) [10-12]. So far patients with severe emphysema and established PH have been excluded from LVRS as well as from endoscopic lung volume reduction (ELVR) therapy.
Whether bronchoscopic lung volume reduction in COPD patients with silver nitrate or histoacryl influences the severity of PH in patients with severe emphysema and PH has yet to be elucidated.
This study is designed as a prospective pilot study, with the primary endpoint being changes in pulmonary hemodynamic parameters after ELVR in patients with severe emphysema.
Secondary endpoints will be changes in lung function parameters, exercise capacity, and QoL.
Materials and Methods This is Prospective descriptive study on 20 COPD Patients with predominant emphysema especially with heterogeneous and upper lobe predominance emphysema admitted in chest department at Kasr al Ainy Hospital. All patients will be on optimal medical treatment for COPD according to Global Initiative for Chronic Obstructive Lung Disease guidelines [13] All patients will be subjected to the following at base line.
- full history taking.
- full clinical examination.
- plain chest x ray.
- an electrocardiogram, High resolution computed tomography of the chest.
- Pulmonary function tests and ABG.
- 6-minute walk test.
- 2-D echocardiography at rest
- Right heart catheterization (RHC)
- Fiberoptic bronchoscopy with application of silver nitrate or histoacryl. The patients will be followed up every month by
- Dyspnea score (using mMRC score) 2. 6-minute walk test. 3. ECG At 3rd Month 2-D echocardiography at rest will be done At 6th Month 2-D echocardiography at rest And RHC will be done .
- Keywords
- Pulmonary Hypertension, Emphysema, COPD
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive, Emphysema
What is being measured
The primary outcome is the main question the study is designed to answer.
change in mean Pulmonary artery pressure after ELVR
Right heart cathetrization
Measured: 3months, 6monthes
Secondary outcomes (1)
Dysnea Score
using modified Medical Research Council (mMRC) criteria, with 0 representing dyspnea with strenuous exercise and 4 representing dyspnea with breathlessness when dressing
Measured: 3 months,6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Elshazly, Cairo University
- Investigators
- Mohamed A Elnady, MD, Study director, Professor of pulmonary Medicine ,Cairo UniversityKarim Mahmoud, MD, Study director, Lecturer of cardiology ,Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778802
- Sponsor's protocol ID
- Cairo2002
- Status last verified
- Jan 2017
- First submitted
- 14 May 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Publication in peer reviewed Journal
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Hemodynamics in Patients With Severe Emphysema Pre and Post Bronchoscopic Volume Reduction by Histoacryl or Silver Nitrate (Single Center Experince )
- ClinicalTrials.gov ID
- NCT02778802
- Acronym / sponsor ID
- Cairo2002
- Keywords
- Pulmonary Hypertension, Emphysema, COPD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 20 May 2016 (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.
This study is designed as a prospective study, with the primary endpoint being changes in pulmonary hemodynamic parameters after ELVR in patients with severe emphysema.
Secondary endpoints will be changes in lung function parameters, exercise capacity, and QoL.
Detailed description
Chronic obstructive pulmonary disease (COPD) continues to be a leading cause of morbidity and is currently the third most common cause of mortality worldwide (1).
In most patients with severe COPD, chronic airflow limitation, lung emphysema with parenchymal destruction and the development of air bullae also occur (2-3) Pulmonary hypertension (PH) is a common consequence of COPD, although the actual overall prevalence of PH in COPD remains unclear (4). Among COPD patients who were to undergo lung-volume-reduction surgery or lung transplantation, mild PH was observed in 50.2%, moderate PH in 9.8%, and severe PH in 3.7%(5). While in most COPD patients who develop PH, pulmonary arterial pressure is only mildly or moderately elevated, (6) PH has an independent prognostic impact on survival. (6,7) The therapeutic options for COPD patients with severe emphysema are limited. Lung volume reduction surgery (LVRS) has been performed as treatment in selected cases, but the referral of patients has been severely influenced by the marked perioperative morbidity and mortality [8]. Less invasive techniques have been developed with the aim of improving patients' pulmonary function, symptoms, and quality of life (QoL) [9]. Among them, the one most commonly used is the endoscopic placement of one way endobronchial valves (EBV) [10-12]. So far patients with severe emphysema and established PH have been excluded from LVRS as well as from endoscopic lung volume reduction (ELVR) therapy.
Whether bronchoscopic lung volume reduction in COPD patients with silver nitrate or histoacryl influences the severity of PH in patients with severe emphysema and PH has yet to be elucidated.
This study is designed as a prospective pilot study, with the primary endpoint being changes in pulmonary hemodynamic parameters after ELVR in patients with severe emphysema.
Secondary endpoints will be changes in lung function parameters, exercise capacity, and QoL.
Materials and Methods This is Prospective descriptive study on 20 COPD Patients with predominant emphysema especially with heterogeneous and upper lobe predominance emphysema admitted in chest department at Kasr al Ainy Hospital. All patients will be on optimal medical treatment for COPD according to Global Initiative for Chronic Obstructive Lung Disease guidelines [13] All patients will be subjected to the following at base line.
- full history taking.
- full clinical examination.
- plain chest x ray.
- an electrocardiogram, High resolution computed tomography of the chest.
- Pulmonary function tests and ABG.
- 6-minute walk test.
- 2-D echocardiography at rest
- Right heart catheterization (RHC)
- Fiberoptic bronchoscopy with application of silver nitrate or histoacryl. The patients will be followed up every month by
- Dyspnea score (using mMRC score) 2. 6-minute walk test. 3. ECG At 3rd Month 2-D echocardiography at rest will be done At 6th Month 2-D echocardiography at rest And RHC will be done .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD Patients with predominant emphysema especially with heterogeneous and upper lobe predominance emphysema
Key inclusion criteria (1 listed)
- COPD patients with predominant emphysema especially with heterogeneous and upper lobe predominance emphysema
Key exclusion criteria (2 listed)
- Airflow limitation with FEV1 < 20%.
- Patients not candidate for FOB.
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
change in mean Pulmonary artery pressure after ELVR
Time frame: 3months, 6monthes
Right heart cathetrization
1 secondary outcome
Dysnea Score
Time frame: 3 months,6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Individual participant dataSharing planned: Yes. Publication in peer reviewed Journal
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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.
Mohamed A Elnady, MD study director
Professor of pulmonary Medicine ,Cairo University
Karim Mahmoud, MD study director
Lecturer of cardiology ,Cairo University
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 Pulmonary Hypertension and Chronic Obstructive Lung Disease, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Jan 2017. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa I Elshazly, MD (00201001272020, elshazly66@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in mean Pulmonary artery pressure after ELVR (time frame: 3months, 6monthes). It is what the study was designed to measure, not a finding.
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 4 Jan 2017.