Pulmonary Hypertension in Hypersensitivity Pneumonitis

November 17, 2020 updated by: Medical University of Graz

Recognition of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis

The investigation serves the identification of pulmonary hypertension (PH) among patients with hypersensitivity pneumonitis (HP). The exact prevalence of PH in HP is unknown. Data from South America indicate that the prevalence of pre-capillary PH amongst patients with HP is higher than 20%. There are no reliable data from Europe so far. According to the investigators previous analysis, more than 400 HP patients have participated in pulmonary rehabilitation at least once in the past 10 years at Klinikum Bad Gleichenberg (Rehabilitation Center for Agricultural Workers in Austria). This collective of patients is to be invited to participate in the study.

A diagnostic algorithm will be applied in the clinical trial, in the case of clinical suspicion the diagnosis of PH will be confirmed by right heart catheterization. Besides the determination of the prevalence of PH in patients with HP the investigators aim to assess the reliability of non-invasive methods (e.g. Echocardiography, ECG...) to predict PH.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

426

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with confirmed Hypersensitivity Pneumonitis

Description

Inclusion Criteria:

  • Patients with confirmed Hypersensitivity Pneumonitis
  • written consent
  • Age: 18-90 years

Exclusion Criteria:

  • severe impairment of the general health condition
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of pulmonary hypertension
Time Frame: 4 year
4 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

Ludwig Boltzmann Institute for Lung Vascular Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

October 31, 2020

Study Completion (Actual)

October 31, 2020

Study Registration Dates

First Submitted

January 23, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (Estimate)

January 25, 2017

Study Record Updates

Last Update Posted (Actual)

November 19, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28-037 ex 15/16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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