NCT02778802

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

May 14, 2016

Last Update Submit

January 1, 2017

Conditions

Pulmonary HypertensionChronic Obstructive Lung Disease

Keywords

Pulmonary HypertensionEmphysemaCOPD

Outcome Measures

Primary Outcomes (1)

  • change in mean Pulmonary artery pressure after ELVR

    Right heart cathetrization

    3months, 6monthes

Secondary Outcomes (1)

  • Dysnea Score

    3 months,6months

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Airflow limitation with FEV1 \< 20%.
  • Patients not candidate for FOB.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alaini School of Medicine

Cairo, 14211, Egypt

RECRUITING

MeSH Terms

Conditions

Hypertension, PulmonaryPulmonary Disease, Chronic ObstructiveEmphysema

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed A Elnady, MD

    Professor of pulmonary Medicine ,Cairo University

    STUDY DIRECTOR

  • Karim Mahmoud, MD

    Lecturer of cardiology ,Cairo University

    STUDY DIRECTOR

Central Study Contacts

Mostafa I Elshazly, MD

CONTACT

00201001272020elshazly66@hotmail.com

Ahmed M Abd El-Fattah, MSc

CONTACT

00201003655626a.house2012@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of pulmonary Medicine

Study Record Dates

First Submitted

May 14, 2016

First Posted

May 20, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

January 4, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

Publication in peer reviewed Journal

Locations

EG(1)