- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03030807
Pulmonary Hypertension in Hypersensitivity Pneumonitis
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Respiratory Hypersensitivity
- Lung Diseases, Interstitial
- Hypersensitivity
- Hypertension
- Pneumonia
- Hypertension, Pulmonary
- Alveolitis, Extrinsic Allergic
Other Study ID Numbers
- 28-037 ex 15/16
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