Back to resultsPredictors of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis
Primary Purpose
Pulmonary Hypertension, Hypersensitivity Pneumonitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Right heart catheter
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Hypertension
Eligibility Criteria
Inclusion Criteria:
- All patients with confirmed diagnosis of Hypersensitivity pneumonitis
Exclusion Criteria:
- Other interstitial lung diseases
Sites / Locations
- Kasr alainy school of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
HP without Pulmonary hypertion
HP with Pulmonary hypertion
Arm Description
HRCT chest , pulmonary functions and echocardiography
HRCT chest , pulmonary functions ,echocardiography and RT heart catheter in high echocardiographic probability of PH
Outcomes
Primary Outcome Measures
Percentage of pulmonary hypertension in patients with HP
primary oucome
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05458635
Brief Title
Predictors of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis
Official Title
Predictors of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
March 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, Hypersensitivity Pneumonitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HP without Pulmonary hypertion
Arm Type
No Intervention
Arm Description
HRCT chest , pulmonary functions and echocardiography
Arm Title
HP with Pulmonary hypertion
Arm Type
Active Comparator
Arm Description
HRCT chest , pulmonary functions ,echocardiography and RT heart catheter in high echocardiographic probability of PH
Intervention Type
Procedure
Intervention Name(s)
Right heart catheter
Intervention Description
Right heart catheterization was performed for 4 cases with high probability of pulmonary hypertension using multi-lumen swan ganz catheter.
Primary Outcome Measure Information:
Title
Percentage of pulmonary hypertension in patients with HP
Description
primary oucome
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients with confirmed diagnosis of Hypersensitivity pneumonitis
Exclusion Criteria:
Other interstitial lung diseases
Facility Information:
Facility Name
Kasr alainy school of medicine
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Predictors of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis
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