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Pulmonary Hypertension in Hypersensitivity Pneumonitis

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ClinicalTrials.gov Identifier: NCT03030807
Recruitment Status : Enrolling by invitation
First Posted : January 25, 2017
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
Ludwig Boltzmann Institute Lung Vascular Research
Information provided by (Responsible Party):
Medical University of Graz

Brief 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.


Condition or disease Intervention/treatment
Pulmonary Hypertension Diagnostic Test: Right heart cathetarization (in case of suspected PH)

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Recognition of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis
Study Start Date : October 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020





Primary Outcome Measures :
  1. Prevalence of pulmonary hypertension [ Time Frame: 4 year ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with confirmed Hypersensitivity Pneumonitis
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • severe impairment of the general health condition
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030807


Sponsors and Collaborators
Medical University of Graz
Ludwig Boltzmann Institute Lung Vascular Research
Investigators
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Principal Investigator: Horst Olschewski, MD Medical University of Graz

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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03030807     History of Changes
Other Study ID Numbers: 28-037 ex 15/16
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Pneumonia
Alveolitis, Extrinsic Allergic
Hypertension
Hypersensitivity
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Immune System Diseases
Respiratory Tract Infections
Lung Diseases, Interstitial
Respiratory Hypersensitivity
Hypersensitivity, Immediate