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NCT03030807 Clinical Trial

Pulmonary Hypertension in Hypersensitivity Pneumonitis

Pulmonary Hypertension Clinical Trial

Official title:
Recognition of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03030807
Other study ID # 28-037 ex 15/16
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2016
Est. completion date October 31, 2020

Study information
Verified date November 2020
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 426
Est. completion date October 31, 2020
Est. primary completion date October 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Patients with confirmed Hypersensitivity Pneumonitis - written consent - Age: 18-90 years Exclusion Criteria: - severe impairment of the general health condition - pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Right heart catheterization (in case of suspected PH)

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Medical University of Graz Ludwig Boltzmann Institute for Lung Vascular Research

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of pulmonary hypertension 4 year
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