Pulmonary Hemodynamics in Patients With Severe Emphysema Pre and Post BLVR

Pulmonary Hypertension Clinical Trial

Official title:

Pulmonary Hemodynamics in Patients With Severe Emphysema Pre and Post Bronchoscopic Volume Reduction by Histoacryl or Silver Nitrate (Single Center Experince )

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02778802
• Other study ID #: Cairo2002
• Status: Recruiting
• Phase: N/A
• First received: May 14, 2016
• Last updated: January 1, 2017
• Start date: June 2016
• Est. completion date: May 2017

Study information

• Verified date: January 2017
• Source: Cairo University
• Contact: Mostafa I Elshazly, MD
• Phone: 00201001272020
• Email: elshazly66[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational

Clinical 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.

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

1. 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• COPD patients with predominant emphysema especially with heterogeneous and upper lobe predominance emphysema

Exclusion Criteria:

1. Airflow limitation with FEV1 < 20%.

2. Patients not candidate for FOB.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Lung Disease
• Emphysema
• Hypertension
• Hypertension, Pulmonary
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema
• Pulmonary Hypertension

Locations

Country	Name	City	State
Egypt	Kasr Alaini School of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in mean Pulmonary artery pressure after ELVR	Right heart cathetrization	3months, 6monthes	No
Secondary	Dysnea Score	using modified Medical Research Council (mMRC) criteria, with 0 representing dyspnea with strenuous exercise and 4 representing dyspnea with breathlessness when dressing	3 months,6months	No