Pulmonary HypertensionNCT05458635
Predictors of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis
A study testing Right heart catheter in people with Pulmonary Hypertension and Hypersensitivity Pneumonitis, run by Cairo University at 1 site in Egypt.
Trial summary
Hypersensitivity pneumonitis (HP) is a complex immune mediated disorders caused by repeated inhalation of and sensitization to wide range of antigens including organic particles and chemical compounds, leading to exaggerated immuneresponse. Read more about this study
- Who is it for?
- Ages 29 to 55 years
- Conditions the study is for
- Pulmonary Hypertension, Hypersensitivity Pneumonitis
- What is being tested?
- Right heart catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to 15 Mar 2021
- Phase
- Interventional
- 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 29 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients with confirmed diagnosis of Hypersensitivity pneumonitis
Who cannot join
- Other interstitial lung diseases
Trial locations and contacts
1 site in 1 country.
About this study
Hypersensitivity pneumonitis (HP) is a complex immune mediated disorders caused by repeated inhalation of and sensitization to wide range of antigens including organic particles and chemical compounds, leading to exaggerated immuneresponse. Hypersenstivity pneumonitis is a common form of diffuse parenchymal lung diseases in Egypt .Pulmonary hypertension has been found as a complication of a number of diseases affecting the lung interstitium, including hypersensitivity pneumonitis, with subsequent affection of the life expectancy Rationale of the study: to find predictors for the development of pulmonary hypertension in patients with hypersensitivity pneumonitis
Read the detailed description
Cross sectional study included 60 patients with established diagnosis of HP , work up includes history of exposure, clinical examination, HRCT chest, ABGs,6MWD, desaturation degree , spirometry, echocardiography and right heart catheter in patients with high echo probability of PH.
- Being tested
- Right heart catheter
- Medical subject headings
- Hypertension, Pulmonary, Alveolitis, Extrinsic Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right heart catheterProcedure or surgery
Right heart catheterization was performed for 4 cases with high probability of pulmonary hypertension using multi-lumen swan ganz catheter.
| Study group | Role | What they receive |
|---|---|---|
| HP without Pulmonary hypertion | No intervention | HRCT chest , pulmonary functions and echocardiography |
| HP with Pulmonary hypertion | Active comparator | HRCT chest , pulmonary functions ,echocardiography and RT heart catheter in high echocardiographic probability of PH Receives: Procedure: Right heart catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of pulmonary hypertension in patients with HP
primary oucome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Aug 2019
- Primary completion31 Oct 2020
- Study completion15 Mar 2021
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Kamal Ibrahim Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458635
- Sponsor's protocol ID
- MS-131-2019
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elnady MA, Elkorashy R, Nabil A, Ibrahim EK. Predictors of pulmonary hypertension in patients with hypersensitivity pneumonitis. BMC Pulm Med. 2023 Feb 9;23(1):61. doi: 10.1186/s12890-023-02347-1.
PubMed 36759788
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis
- ClinicalTrials.gov ID
- NCT05458635
- Acronym / sponsor ID
- MS-131-2019
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 14 Jul 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.
Hypersensitivity pneumonitis (HP) is a complex immune mediated disorders caused by repeated inhalation of and sensitization to wide range of antigens including organic particles and chemical compounds, leading to exaggerated immuneresponse. Hypersenstivity pneumonitis is a common form of diffuse parenchymal lung diseases in Egypt .Pulmonary hypertension has been found as a complication of a number of diseases affecting the lung interstitium, including hypersensitivity pneumonitis, with subsequent affection of the life expectancy Rationale of the study: to find predictors for the development of pulmonary hypertension in patients with hypersensitivity pneumonitis
Detailed description
Cross sectional study included 60 patients with established diagnosis of HP , work up includes history of exposure, clinical examination, HRCT chest, ABGs,6MWD, desaturation degree , spirometry, echocardiography and right heart catheter in patients with high echo probability of PH.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HP without Pulmonary hypertion | No intervention | –HRCT chest , pulmonary functions and echocardiography |
| HP with Pulmonary hypertion | Active comparator | Procedure: Right heart catheterHRCT chest , pulmonary functions ,echocardiography and RT heart catheter in high echocardiographic probability of PH |
Who may qualify
- Ages
- 29 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patients with confirmed diagnosis of Hypersensitivity pneumonitis
Key exclusion criteria (1 listed)
- Other interstitial lung diseases
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 heart catheterRight heart catheterization was performed for 4 cases with high probability of pulmonary hypertension using multi-lumen swan ganz catheter. | Procedure or surgery | HP with Pulmonary hypertion |
Primary outcome
Percentage of pulmonary hypertension in patients with HP
Time frame: 6 months
primary oucome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Derived from this study: PubMed 36759788Elnady MA, Elkorashy R, Nabil A, Ibrahim EK. Predictors of pulmonary hypertension in patients with hypersensitivity pneumonitis. BMC Pulm Med. 2023 Feb 9;23(1):61. doi: 10.1186/s12890-023-02347-1.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right heart catheter in people with Pulmonary Hypertension and Hypersensitivity Pneumonitis, 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 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: finished, as of the sponsor's last update on 14 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of pulmonary hypertension in patients with HP (time frame: 6 months). 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 NCT05458635, 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 14 Jul 2022.