NCT05458635

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

1.3 years

First QC Date

July 4, 2022

Last Update Submit

July 12, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of pulmonary hypertension in patients with HP

    primary oucome

    6 months

Study Arms (2)

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

Procedure: Right heart catheter

Interventions

Right heart catheterization was performed for 4 cases with high probability of pulmonary hypertension using multi-lumen swan ganz catheter.

HP with Pulmonary hypertion

Eligibility Criteria

Age29 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All patients with confirmed diagnosis of Hypersensitivity pneumonitis

You may not qualify if:

  • Other interstitial lung diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr alainy school of medicine

Cairo, 11562, Egypt

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypertension, PulmonaryAlveolitis, Extrinsic Allergic

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesLung Diseases, InterstitialRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of pulmonology

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 14, 2022

Study Start

August 1, 2019

Primary Completion

October 31, 2020

Study Completion

March 15, 2021

Last Updated

July 14, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations