NCT02774928

Brief Summary

Development of pulmonary hypertension (PH) in chronic lung diseases has both functional and prognostic implications . PH in Lung diseases is usually mild to moderate with preserved cardiac output, and evolves slowly alongside the progression of lung disease and hypoxemia . However, a minority of patients develop severe PH with elevations in pulmonary artery pressure that have been described as ''out of proportion'' to the underlying disease . The aim of this study is to compare the characteristics and outcomes of consecutive patients with PH-due to lung diseases diagnosed at our specialist referral center over a 1-year period.

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
150

participants targeted

Target at P50-P75 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 13, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
15 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

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

11 months

First QC Date

May 13, 2016

Last Update Submit

July 11, 2016

Conditions

Keywords

Pulmonary HypertensionCOPDILDOSA

Outcome Measures

Primary Outcomes (1)

  • prevalence of PH

    1 year

Study Arms (3)

Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality throughout the world.COPD, a common preventable and treatable disease, is characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. Exacerbations and comorbidities contribute to the overall severity in individual patients.Spirometry is required to make a clinical diagnosis of COPD; the presence of a post-bronchodilator FEV1/FVC \< 0.70 confirms the presence of persistent airflow limitation and thus of COPD .

Interstitial lung diseases

Interstitial lung disease is a general category that includes many different lung conditions. All interstitial lung diseases affect the interstitium, a part of the lungs' anatomic structure.

Obstructive sleep apnea (OSA)

Obstructive sleep apnea (OSA) is a sleep disorder that involves cessation or significant decrease in airflow in the presence of breathing effort. It is the most common type of sleep-disordered breathing and is characterized by recurrent episodes of upper airway collapse during sleep. These episodes are associated with recurrent oxyhemoglobin desaturations and arousals from sleep. OSA that is associated with excessive daytime sleepiness is commonly called obstructive sleep apnea syndrome-also referred to as obstructive sleep apnea-hypopnea syndrome.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with chronic lung diseases COPD ILD OSA sarcodosis

You may qualify if:

  • COPD diagnosed according to Gold 2015
  • Interstial lung diseases
  • Obstructive Sleep Apnea
  • sarcoidosis

You may not qualify if:

  • Bronchogenic carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alaini

Cairo, 12411, Egypt

RECRUITING

MeSH Terms

Conditions

Hypertension, PulmonaryPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mostafa I Elshazly, MD

    Kasr Alaini school of Medicine

    PRINCIPAL INVESTIGATOR
  • Yusif Amin, MD

    Kasr Alaini school of Medicine

    STUDY DIRECTOR

Central Study Contacts

Mostafa I Elshazly, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 13, 2016

First Posted

May 17, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

July 12, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

publication at international journal

Locations