Pulmonary Hemodynamics in Patients With Severe Emphysema Pre and Post BLVR

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Hypertension; Chronic Obstructive Lung Disease

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 .

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Ahmed M Abd El-Fattah, MSc; Phone Number: 00201003655626; Email: a.house2012@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt, 14211
    • Recruiting
    • Kasr Alaini School of Medicine
    • Principal Investigator: Mostafa Elshazly, MD
    • Sub-Investigator: Mohamed Alnady, MD
    • Sub-Investigator: Karim Mahmoud, MD
    • Sub-Investigator: Ahmed Amer, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COPD Patients with predominant emphysema especially with heterogeneous and upper lobe predominance emphysema

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in mean Pulmonary artery pressure after ELVR	Right heart cathetrization	3months, 6monthes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Mohamed A Elnady, MD, Professor of pulmonary Medicine ,Cairo University; Study Director: Karim Mahmoud, MD, Lecturer of cardiology ,Cairo University

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: May 14, 2016
• First Submitted That Met QC Criteria: May 19, 2016
• First Posted (Estimate): May 20, 2016

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: January 1, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: COPD; Pulmonary Hypertension; Emphysema
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Hypertension; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema; Hypertension, Pulmonary
• Other Study ID Numbers: Cairo2002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publication in peer reviewed Journal