AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
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.

Mahmoud Badwy, specialist contact

01030382070

mah55667755@gmail.com

Mahmoud Badwy, specialis contact

01030382070

mah55667755@gmail.com

Egypt1 site, 1 recruiting
  • Mahmoud Badwy

    Asyut

    Mahmoud Badwy, specialist, mah55667755@gmail.com

    Recruiting

Other trials in Egypt

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

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. 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.

  1. First posted22 Sep 2023
  2. Study start1 Dec 2023 (estimated)
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

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)
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.

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in