Clinical trial NCT02778802: Pulmonary Hemodynamics in Patients With Severe Emphysema Pre and Post BLVR
Official title: Pulmonary Hemodynamics in Patients With Severe Emphysema Pre and Post Bronchoscopic Volume Reduction by Histoacryl or Silver Nitrate (Single Center Experince )
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Hypertension
Chronic Obstructive Lung Disease
Keywords: Pulmonary Hypertension
Emphysema
COPD
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD Patients with predominant emphysema especially with heterogeneous and upper lobe predominance emphysema

Brief 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.

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

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: change in mean Pulmonary artery pressure after ELVR
timeFrame: 3months, 6monthes
Secondary outcomes:
measure: Dysnea Score
timeFrame: 3 months,6months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alaini School of Medicine
Study officials:
affiliation: Professor of pulmonary Medicine ,Cairo University
name: Mohamed A Elnady, MD
role: STUDY_DIRECTOR
affiliation: Lecturer of cardiology ,Cairo University
name: Karim Mahmoud, MD
role: STUDY_DIRECTOR
References: