1- Haemodynamic Phenotyping of the Out - of - Proportion PH to Guide Different Therapeutic LinesNCT06051396
Phenotyping of the Out-of-proportion Pulmonary Hypertension
An observational study of 1- Haemodynamic Phenotyping of the Out - of - Proportion PH to Guide Different Therapeutic Lines, run by Assiut University at 1 site in Egypt.
Trial summary
Pulmonary hypertension (PH) is a pathophysiological disorder that may involve multiple clinical conditions and may be associated with a variety of cardiovascular and respiratory diseases. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- 1- Haemodynamic Phenotyping of the Out - of - Proportion PH to Guide Different Therapeutic Lines
- What is being tested?
- Right sided heart catheterization
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Dec 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All Patients presented with severe pulmonary hypertension (PASP > 70mmHg by echocardiographic assessment) (8) associated with chronic lung diseas will be included in the study
Who may be able to join
- All Patients presented with severe pulmonary hypertension (PASP > 70mmHg by echocardiographic assessment) (8) associated with chronic lung diseas will be included in the study
Who cannot join
- 1- Age under 18 years. 2- Severe PH proportional to the disease. 3- Hemodynamically unstable condition requiring inotropic or vasoactive drugs. 4- Severe chest wall deformity. 5- Pregnant women. 6- Right-sided endocarditis, right-sided tumor, or thrombus. 7- Severe coagulopathy or bleeding diathesis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mahmoud Badwy
Asyut
Mahmoud Badwy, specialist, mah55667755@gmail.com
About this study
Pulmonary hypertension (PH) is a pathophysiological disorder that may involve multiple clinical conditions and may be associated with a variety of cardiovascular and respiratory diseases. The complexity of managing PH requires a multidisciplinary approach, with active involvement of patients with PH in partnership with clinicians.(1) All age groups are affected. Present estimates suggest a PH prevalence of 1% of the global population. Due to the presence of cardiac and pulmonary causes of PH, prevalence is higher in individuals aged 65 years. Globally, LHD is the leading cause of PH. Lung disease, especially chronic obstructive pulmonary disease (COPD), is the second most common cause. In the UK, the observed PH prevalence has doubled in the last 10 years and is currently 125 cases/million inhabitants. (2) Pulmonary hypertension is defined by a mean pulmonary arterial pressure (mPAP) more than 20 mmHg at rest according to the 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension . It is essential to include PVR and pulmonary arterial wedge pressure (PAWP) in the definition of pre-capillary PH, in order to discriminate elevated PAP due to pulmonary vascular disease (PVD) from that due to left heart disease (LHD), elevated pulmonary blood flow, or increased intrathoracic pressure.(3) Clinical classification of pulmonary hypertension includes GROUP 1 Pulmonary arterial hypertension (PAH), GROUP 2 PH associated with left heart disease, GROUP 3 PH associated with lung diseases and/or hypoxia, GROUP 4 PH associated with pulmonary artery obstructions and GROUP 5 PH with unclear and/or multifactorial mechanisms. (3) Pulmonary hypertension is frequently observed in patients with COPD and/or emphysema, diffuse parenchymal lung diseases and hypoventilation syndromes. Pulmonary hypertension is uncommon in obstructive sleep apnoea unless other conditions coexist, such as COPD or daytime hypoventilation.
In patients with lung disease, PH is categorized as non-severe or severe, Whereas non-severe PH is common in advanced COPD and ILD defined by spirometric criteria, severe PH is uncommon, occurring in 1-5% of cases of COPD and ,10% of patients with advanced ILD, with limited data in obesity hypoventilation syndrome.(4) Pulmonary hypertension presenting in patients with lung disease may be due to a number of causes, including undiagnosed CTEPH or PAH. A number of distinct phenotypes of PH in patients with lung disease, including a pulmonary vascular phenotype, have been proposed. The pulmonary vascular phenotype is characterized by better preserved spirometry, low DLCO, hypoxaemia, a range of parenchymal involvement on lung imaging, and a circulatory limitation to exercise.(5) Cardiac comorbidities are also common in patients with lung disease and may contribute to increased risk for hospitalization, longer length of stay, pulmonary hypertension and CVD-related mortality.(6) A vast category of patients suffering from parenchymal lung diseases (often accompanied by minor pulmonary impairment on pulmonary function test and/or CT scan) with an unexplained severe degree of PH was brought to the attention of physicians. In these patients, the development of moderate to severe PH, which is disproportionate to the degree of parenchymal lung disease and hypoxia, has been termed "out-of-proportion" PH, and an arbitrary value of . 35 mm Hg mean pulmonary artery pressure has been selected to identify this category of patients.(7) and there is limited data about the Out-of proportion PH and it different phenotypes
- Conditions
- 1- Haemodynamic Phenotyping of the Out - of - Proportion PH to Guide Different Therapeutic Lines
- Being tested
- Right sided heart catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right sided heart catheterizationProcedure or surgery
Hemodynamic evaluation was performed in the supine position. RHC was performed using the modified Seldinger technique with an 8F sheath inserted in the jugular, basilic or cephalic vein . The Swan-Ganz catheter was a 7F, two-lumen, fluid filled, and pressure-measuring tipped catheter (Corodyn TD; Braun Medical, Bethlehem, PA, USA). The zero-level reference was determined at midthoracic line.(9)
What is being measured
The primary outcome is the main question the study is designed to answer.
1- Haemodynamic phenotyping of the out - of - proportion PH to guide different therapeutic lines
Identification of different phenotypes of severe pulmnary hypertension
Measured: 2 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 1- Haemodynamic Phenotyping of the Out - of - Proportion PH to Guide Different Therapeutic LinesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Badwy, Assiut University
- Investigators
- Mahmoud Badwy, specialist, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051396
- Sponsor's protocol ID
- Assiut 3131
- Status last verified
- Nov 2023
- First submitted
- 18 Sep 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Humbert M, Germany MMH, Berger RMF, Denmark JC, Germany EM, Germany BN, et al. 2022 ESC / ERS Guidelines for the diagnosis and treatment of pulmonary hypertension Developed by the task force for the diagnosis and treatment of ( ESC ) and the European Respiratory Society ( ERS ). Endorsed by the International Society for Heart and Lu. Eur Heart J. 2022;1-114.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping of the Out-of-proportion Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT06051396
- Acronym / sponsor ID
- Assiut 3131
- Conditions
- 1- Haemodynamic Phenotyping of the Out - of - Proportion PH to Guide Different Therapeutic Lines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 22 Sep 2023 (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.
Pulmonary hypertension (PH) is a pathophysiological disorder that may involve multiple clinical conditions and may be associated with a variety of cardiovascular and respiratory diseases. The complexity of managing PH requires a multidisciplinary approach, with active involvement of patients with PH in partnership with clinicians.(1) All age groups are affected. Present estimates suggest a PH prevalence of 1% of the global population. Due to the presence of cardiac and pulmonary causes of PH, prevalence is higher in individuals aged 65 years. Globally, LHD is the leading cause of PH. Lung disease, especially chronic obstructive pulmonary disease (COPD), is the second most common cause. In the UK, the observed PH prevalence has doubled in the last 10 years and is currently 125 cases/million inhabitants. (2) Pulmonary hypertension is defined by a mean pulmonary arterial pressure (mPAP) more than 20 mmHg at rest according to the 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension . It is essential to include PVR and pulmonary arterial wedge pressure (PAWP) in the definition of pre-capillary PH, in order to discriminate elevated PAP due to pulmonary vascular disease (PVD) from that due to left heart disease (LHD), elevated pulmonary blood flow, or increased intrathoracic pressure.(3) Clinical classification of pulmonary hypertension includes GROUP 1 Pulmonary arterial hypertension (PAH), GROUP 2 PH associated with left heart disease, GROUP 3 PH associated with lung diseases and/or hypoxia, GROUP 4 PH associated with pulmonary artery obstructions and GROUP 5 PH with unclear and/or multifactorial mechanisms. (3) Pulmonary hypertension is frequently observed in patients with COPD and/or emphysema, diffuse parenchymal lung diseases and hypoventilation syndromes. Pulmonary hypertension is uncommon in obstructive sleep apnoea unless other conditions coexist, such as COPD or daytime hypoventilation.
In patients with lung disease, PH is categorized as non-severe or severe, Whereas non-severe PH is common in advanced COPD and ILD defined by spirometric criteria, severe PH is uncommon, occurring in 1-5% of cases of COPD and ,10% of patients with advanced ILD, with limited data in obesity hypoventilation syndrome.(4) Pulmonary hypertension presenting in patients with lung disease may be due to a number of causes, including undiagnosed CTEPH or PAH. A number of distinct phenotypes of PH in patients with lung disease, including a pulmonary vascular phenotype, have been proposed. The pulmonary vascular phenotype is characterized by better preserved spirometry, low DLCO, hypoxaemia, a range of parenchymal involvement on lung imaging, and a circulatory limitation to exercise.(5) Cardiac comorbidities are also common in patients with lung disease and may contribute to increased risk for hospitalization, longer length of stay, pulmonary hypertension and CVD-related mortality.(6) A vast category of patients suffering from parenchymal lung diseases (often accompanied by minor pulmonary impairment on pulmonary function test and/or CT scan) with an unexplained severe degree of PH was brought to the attention of physicians. In these patients, the development of moderate to severe PH, which is disproportionate to the degree of parenchymal lung disease and hypoxia, has been termed "out-of-proportion" PH, and an arbitrary value of . 35 mm Hg mean pulmonary artery pressure has been selected to identify this category of patients.(7) and there is limited data about the Out-of proportion PH and it different phenotypes
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Patients presented with severe pulmonary hypertension (PASP > 70mmHg by echocardiographic assessment) (8) associated with chronic lung diseas will be included in the study
Key inclusion criteria (1 listed)
- All Patients presented with severe pulmonary hypertension (PASP > 70mmHg by echocardiographic assessment) (8) associated with chronic lung diseas will be included in the study
Key exclusion criteria (1 listed)
- 1- Age under 18 years. 2- Severe PH proportional to the disease. 3- Hemodynamically unstable condition requiring inotropic or vasoactive drugs. 4- Severe chest wall deformity. 5- Pregnant women. 6- Right-sided endocarditis, right-sided tumor, or thrombus. 7- Severe coagulopathy or bleeding diathesis
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 |
|---|---|---|
| Right sided heart catheterizationHemodynamic evaluation was performed in the supine position. RHC was performed using the modified Seldinger technique with an 8F sheath inserted in the jugular, basilic or cephalic vein . The Swan-Ganz catheter was a 7F, two-lumen, fluid filled, and pressure-measuring tipped catheter (Corodyn TD; Braun Medical, Bethlehem, PA, USA). The zero-level reference was determined at midthoracic line.(9) | Procedure or surgery | – |
Primary outcome
1- Haemodynamic phenotyping of the out - of - proportion PH to guide different therapeutic lines
Time frame: 2 yrs
Identification of different phenotypes of severe pulmnary hypertension
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- BackgroundHumbert M, Germany MMH, Berger RMF, Denmark JC, Germany EM, Germany BN, et al. 2022 ESC / ERS Guidelines for the diagnosis and treatment of pulmonary hypertension Developed by the task force for the diagnosis and treatment of ( ESC ) and the European Respiratory Society ( ERS ). Endorsed by the International Society for Heart and Lu. Eur Heart J. 2022;1-114.
- Individual participant dataSharing planned: Undecided
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.
Mahmoud Badwy, specialist principal investigator
Assiut University
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 1- Haemodynamic Phenotyping of the Out - of - Proportion PH to Guide Different Therapeutic Lines, run by Assiut 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 1 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 24 Nov 2023. 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 Mahmoud Badwy, specialist (01030382070, mah55667755@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1- Haemodynamic phenotyping of the out - of - proportion PH to guide different therapeutic lines (time frame: 2 yrs). 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 NCT06051396, which also lists 1 linked publication.
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 24 Nov 2023.