Patients With Pulmonary HypertensionNCT05207683
Pulmonary Hypertension in Patients Attending Sohag University Hospital: A Focus on The Etiology
An observational study of Patients With Pulmonary Hypertension, run by Sohag University at 1 site in Egypt.
Trial summary
Assessment of pulmonary hypertension in patients attending Sohag university hospital ( in out patient clinic or in patient) focusing on the etiology of pulmonary hypertension Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Pulmonary Hypertension
- What is being tested?
- echocardiography
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to Sep 2022
- 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: pulmonary hypertension patients attending Sohag university hospital (either admitted in the hospital or attending the out patient clinics)
Who may be able to join
- patients who are 18 years old or more
- patients with pulmonary hypertension diagnosed with echocardiography
Who cannot join
- patient who are less than 18 years old
Trial locations and contacts
1 site in 1 country.
kamal a ata, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Osama R ElSherif, professor
About this study
Assessment of pulmonary hypertension in patients attending Sohag university hospital ( in out patient clinic or in patient) focusing on the etiology of pulmonary hypertension
- Conditions
- Patients With Pulmonary Hypertension
- Being tested
- echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyOther
Also called electrocardiogram, chest X ray, high resolution Ct chest, spirometry
All the patients will be subjected to thorough medical history and clinical examination and the results of the previous investigations will be collected aiming for reaching the diagnosis of the etiology of pulmonary hypertension. ct pulmonary angiography and then right heart catheterization will be done in case of undiagnosed etiology.
| Study group | Role | What they receive |
|---|---|---|
| patients with pulmonary hypertension | patients who are more than 18 years old , diagnosed with pulmonary hypertension by echocardiography Receives: Other: echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of the causes of pulmonary hypertension in patients attending Sohag university hospital
We will diagnose the cause of pulmonary hypertension in each participant. This will be done by following the diagnostic algorithm of European Society of Cardiology/ European Respiratory Society (ESC/ERS) 2015 guidelines (e.g. we will exclude that pulmonary hypertension is secondary to pulmonary disease by performing adequate assessment of the patient medical history and clinical examination, performing chest x-ray and or high resolution CT chest, spirometry...), so we will know the pattern of pulmonary hypertension etiology in patients attending of Sohag university hospital
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Oct 2021
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patients With Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Abdo Saad, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207683
- Sponsor's protocol ID
- Soh-Med-21-12-20
- Status last verified
- Jan 2022
- First submitted
- 29 Dec 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prins KW, Thenappan T. World Health Organization Group I Pulmonary Hypertension: Epidemiology and Pathophysiology. Cardiol Clin. 2016 Aug;34(3):363-74. doi: 10.1016/j.ccl.2016.04.001.
PubMed 27443134Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Respir J. 2015 Oct;46(4):903-75. doi: 10.1183/13993003.01032-2015. Epub 2015 Aug 29.
PubMed 26318161Simonneau G, Montani D, Celermajer DS, Denton CP, Gatzoulis MA, Krowka M, Williams PG, Souza R. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019 Jan 24;53(1):1801913. doi: 10.1183/13993003.01913-2018. Print 2019 Jan.
PubMed 30545968
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Hypertension in Patients Attending Sohag University Hospital: A Focus on The Etiology
- ClinicalTrials.gov ID
- NCT05207683
- Acronym / sponsor ID
- Soh-Med-21-12-20
- Conditions
- Patients With Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 26 Jan 2022 (actual)
- 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.
Assessment of pulmonary hypertension in patients attending Sohag university hospital ( in out patient clinic or in patient) focusing on the etiology of pulmonary hypertension
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with pulmonary hypertension | – | Other: echocardiographypatients who are more than 18 years old , diagnosed with pulmonary hypertension by echocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pulmonary hypertension patients attending Sohag university hospital (either admitted in the hospital or attending the out patient clinics)
Key inclusion criteria (2 listed)
- patients who are 18 years old or more
- patients with pulmonary hypertension diagnosed with echocardiography
Key exclusion criteria (1 listed)
- patient who are less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echocardiographyAlso: electrocardiogram, chest X ray, high resolution Ct chest, spirometryAll the patients will be subjected to thorough medical history and clinical examination and the results of the previous investigations will be collected aiming for reaching the diagnosis of the etiology of pulmonary hypertension. ct pulmonary angiography and then right heart catheterization will be done in case of undiagnosed etiology. | Other | patients with pulmonary hypertension |
Primary outcome
Detection of the causes of pulmonary hypertension in patients attending Sohag university hospital
Time frame: one year
We will diagnose the cause of pulmonary hypertension in each participant. This will be done by following the diagnostic algorithm of European Society of Cardiology/ European Respiratory Society (ESC/ERS) 2015 guidelines (e.g. we will exclude that pulmonary hypertension is secondary to pulmonary disease by performing adequate assessment of the patient medical history and clinical examination, performing chest x-ray and or high resolution CT chest, spirometry...), so we will know the pattern of pulmonary hypertension etiology in patients attending of Sohag university hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Background: PubMed 27443134Prins KW, Thenappan T. World Health Organization Group I Pulmonary Hypertension: Epidemiology and Pathophysiology. Cardiol Clin. 2016 Aug;34(3):363-74. doi: 10.1016/j.ccl.2016.04.001.
- Background: PubMed 26318161Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Respir J. 2015 Oct;46(4):903-75. doi: 10.1183/13993003.01032-2015. Epub 2015 Aug 29.
- Background: PubMed 30545968Simonneau G, Montani D, Celermajer DS, Denton CP, Gatzoulis MA, Krowka M, Williams PG, Souza R. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019 Jan 24;53(1):1801913. doi: 10.1183/13993003.01913-2018. Print 2019 Jan.
- Individual participant dataSharing planned: No
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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.
kamal a ata, professor contact
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 Patients With Pulmonary Hypertension, run by Sohag 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 2 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 26 Jan 2022. 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 esraa a saad, assistant lecturer (01065567768 ext. 002, esraa.abdo@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of the causes of pulmonary hypertension in patients attending Sohag university hospital (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05207683, which also lists 3 linked publications.
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 26 Jan 2022.