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Clinical Profile of Patients With Pulmonary Hypertension Due to Lung Diseases ( Single Center Experience)

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ClinicalTrials.gov Identifier: NCT02774928
Recruitment Status : Recruiting
First Posted : May 17, 2016
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Mostafa Elshazly, Cairo University

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.


Condition or disease
Pulmonary Hypertension

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Clinical Profile of Patients With Pulmonary Hypertension Due to Lung Diseases ( Single Center Experience)
Study Start Date : June 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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.




Primary Outcome Measures :
  1. prevalence of PH [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with chronic lung diseases COPD ILD OSA sarcodosis
Criteria

Inclusion Criteria:

  1. COPD diagnosed according to Gold 2015
  2. Interstial lung diseases
  3. Obstructive Sleep Apnea
  4. sarcoidosis

Exclusion Criteria:

  • Bronchogenic carcinoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774928


Contacts
Contact: Mostafa I Elshazly, MD 00201001272020 elshazly66@hotmail.com

Locations
Egypt
Kasr Alaini Recruiting
Cairo, Egypt, 12411
Contact: Mostafa I Elshazly, MD    00201001272020    elshazly66@hotmail.com   
Sub-Investigator: Hebatallah H Assel, MD         
Sub-Investigator: Amira I Alameldin, MD         
Sub-Investigator: Reem Elkorashy, MD         
Sub-Investigator: Eman Kamal, MD         
Sub-Investigator: Naglaa Bakry, MD         
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Mostafa I Elshazly, MD Kasr Alaini school of Medicine
Study Director: Yusif Amin, MD Kasr Alaini school of Medicine

Responsible Party: Mostafa Elshazly, Professor of pulmonary Medicine, Cairo University
ClinicalTrials.gov Identifier: NCT02774928     History of Changes
Other Study ID Numbers: Cairo2001
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: publication at international journal

Keywords provided by Mostafa Elshazly, Cairo University:
Pulmonary Hypertension
COPD
ILD
OSA

Additional relevant MeSH terms:
Hypertension
Lung Diseases
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases