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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Mostafa I Elshazly, MD contact

00201001272020

elshazly66@hotmail.com

Ahmed M Abd El-Fattah, MSc contact

00201003655626

a.house2012@yahoo.com

Egypt1 site, 1 recruiting
  • Kasr Alaini School of Medicine

    Cairo, 14211

    Mostafa I Elshazly, MD, 00201001272020, elshazly66@hotmail.com

    Mostafa Elshazly, MD

    Recruiting

Other trials in Egypt

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.

  1. full history taking.
  2. full clinical examination.
  3. plain chest x ray.
  4. an electrocardiogram, High resolution computed tomography of the chest.
  5. Pulmonary function tests and ABG.
  6. 6-minute walk test.
  7. 2-D echocardiography at rest
  8. Right heart catheterization (RHC)
  9. Fiberoptic bronchoscopy with application of silver nitrate or histoacryl. The patients will be followed up every month by
  10. 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.

  1. change in mean Pulmonary artery pressure after ELVR

    Right heart cathetrization

    Measured: 3months, 6monthes

Secondary outcomes (1)
  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.

  1. First posted20 May 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionMay 2017 (estimated)
  4. Study completionMay 2017 (estimated)

Resources

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)
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

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.

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