Pulmonary HypertensionNCT02774928
Clinical Profile of Patients With Pulmonary Hypertension Due to Lung Diseases ( Single Center Experience)
An observational study of Pulmonary Hypertension, run by Cairo University at 1 site in Egypt.
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2016to May 2017
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with chronic lung diseases COPD ILD OSA sarcodosis
Who may be able to join
- COPD diagnosed according to Gold 2015
- Interstial lung diseases
- Obstructive Sleep Apnea
- sarcoidosis
Who cannot join
- Bronchogenic carcinoma
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alaini
Cairo, 12411
Mostafa I Elshazly, MD, 00201001272020, elshazly66@hotmail.com
Hebatallah H Assel, MD
About this study
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.
Read the detailed 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:
- Detailed standard Demographic \& clinical parameters.
- Assessment of exercise tolerance (6 MWD \& WHO functional capacity)
- Assessment of pulmonary function by PFTs.
- ECG: (Right ventricular strain,Right axis deviation,Right bundle branch block,\& Left side changes 0
- Echocardiographic evaluation for PAH: ( Right atrial area ,Right ventricular area ,Tricuspid regurgitant jet velocity (TR) ,Tricuspid annular plane systolic excursion)
- Radiography: including chest X-ray, HRCT chest, V/Q scan\& CT angiography if needed
- 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
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, COPD, ILD, OSA
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of PH
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Elshazly, Cairo University
- Investigators
- Mostafa I Elshazly, MD, Principal investigator, Kasr Alaini school of MedicineYusif Amin, MD, Study director, Kasr Alaini school of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774928
- Sponsor's protocol ID
- Cairo2001
- Status last verified
- Jul 2016
- First submitted
- 13 May 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: publication at international journal
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Profile of Patients With Pulmonary Hypertension Due to Lung Diseases ( Single Center Experience)
- ClinicalTrials.gov ID
- NCT02774928
- Acronym / sponsor ID
- Cairo2001
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, COPD, ILD, OSA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Detailed standard Demographic \& clinical parameters.
- Assessment of exercise tolerance (6 MWD \& WHO functional capacity)
- Assessment of pulmonary function by PFTs.
- ECG: (Right ventricular strain,Right axis deviation,Right bundle branch block,\& Left side changes 0
- Echocardiographic evaluation for PAH: ( Right atrial area ,Right ventricular area ,Tricuspid regurgitant jet velocity (TR) ,Tricuspid annular plane systolic excursion)
- Radiography: including chest X-ray, HRCT chest, V/Q scan\& CT angiography if needed
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic lung diseases COPD ILD OSA sarcodosis
Key inclusion criteria (4 listed)
- COPD diagnosed according to Gold 2015
- Interstial lung diseases
- Obstructive Sleep Apnea
- sarcoidosis
Key exclusion criteria (1 listed)
- Bronchogenic carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of PH
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Individual participant dataSharing planned: Yes. publication at international journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa I Elshazly, MD principal investigator
Kasr Alaini school of Medicine
Yusif Amin, MD study director
Kasr Alaini school of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa I Elshazly, MD (00201001272020, elshazly66@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of PH (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.