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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02774928
• Other study ID #: Cairo2001
• Status: Recruiting
• Phase: N/A
• First received: May 13, 2016
• Last updated: July 11, 2016
• Start date: June 2016
• Est. completion date: May 2017

Study information

• Verified date: July 2016
• Source: Cairo University
• Contact: Mostafa I Elshazly, MD
• Phone: 00201001272020
• Email: elshazly66[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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 .

Hypotheses for the etiology of this phenotype include greater susceptibility to alveolar hypoxia and/or tobacco smoke , destruction of the capillary vascular bed , inflammatory factors initiating remodeling of the pulmonary vascular bed or the coexistence of idiopathic pulmonary arterial hypertension (IPAH) in patients with lung disease .

Severe PH-lung disease has been arbitrarily defined by a resting mean pulmonary artery pressure (PAP) ≥35 mmHg by RHC . The high and increasing prevalence of chronic lung diseases and the substantial consequences of developing severe PH have generated increasing interest in PH-lung diseases.

Pulmonary vascular research unit at Chest department at Kasr-Alani school of Medicine delivers regional, adult PH service to a population with a chronic lung 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.

Patients diagnosed as chronic lung diseases( COPD,ILD,OSA,Sarcoidosis) will be recruited from out-patient's clinics & inpatients wards of Internal medicine & Chest departments, Kasr Al-ainy hospital (from June 2016 to May 2015) A written informed consent matching with Helsinki declaration will be taken from all patients.

2.2 Study methods:

All the enrolled patients will go through the following basically:

1. Detailed standard Demographic & clinical parameters.

2. Assessment of exercise tolerance (6 MWD & WHO functional capacity)

3. Assessment of pulmonary function by PFTs.

4. ECG: (Right ventricular strain,Right axis deviation,Right bundle branch block,& Left side changes 0

5. Echocardiographic evaluation for PAH: ( Right atrial area ,Right ventricular area ,Tricuspid regurgitant jet velocity (TR) ,Tricuspid annular plane systolic excursion)

6. Radiography: including chest X-ray, HRCT chest, V/Q scan& CT angiography if needed

10. RT sided heart catheterization:

• mPAP

• PCWP

• PVR

• CARDIAC INDEX 11. Statistical analysis: ……..

The subjects will be classified according to RHC into either

• Non PAH groups mPAP ≤ 21mmHG

• PAH mPAP≥ 25 mmHG:

• Severe PH-lung diseases mPAP ≥ 35 mmgh

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. COPD diagnosed according to Gold 2015

2. Interstial lung diseases

3. Obstructive Sleep Apnea

4. sarcoidosis

Exclusion Criteria:

• Bronchogenic carcinoma

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Lung Diseases
• Pulmonary Hypertension

Locations

Country	Name	City	State
Egypt	Kasr Alaini	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of PH		1 year	No