HypErsensitiVity PneumonITis: DiseAse Progression Characterization

Study Overview
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Brief Summary
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EVITA is a multicentric Latin-American prospective cohort on chronic hypersensitivity pneumonitis. EVITA's objective is to identify phenotypes and/or endotypes associated with different disease trajectories measured primarily by forced vital capacity (FVC) during a 24 month follow-up period. Other secondary measures of disease progression will also be investigated such as imaging, time to death or lung transplantation, and patient-reported outcomes

Official Title
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HypErsensitiVity PneumonITis: DiseAse Progression Characterization. An International Multicentric Prospective Observational Study

Conditions
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Hypersensitivity Pneumonitis

Intervention / Treatment
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* Other: Disease assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult outpatient subjects (18 years old or older) that fulfill the 2020 ATS/JRS/ALAT diagnostic criteria of HP of at least moderate confidence (70% confidence or more). Willingness to undergo the evaluations proposed in this protocol HP diagnosis within the last 24 months Presence of radiological or histological fibrosis: 4.a. Radiological fibrosis consists of unequivocal fine or coarse reticulation with architectural lung distortion and/or traction bronchiectasis and/or honeycomb. 4.b. Unequivocal histopathological fibrosis evidenced on lung specimens Exclusion Criteria: Pregnancy Presence of established connective tissue disease Severe comorbidity impacting on the respiratory system as judged by the attending physician (ex. congestive heart failure, neoplasm, post-COVID-19 sequelae) Use of supplemental oxygen at rest Dyspnea mMRC 4 (too breathless to leave the house or breathless when dressing or undressing) Unequivocal emphysematous pattern of HP on HRCT Unequivocal pleuro-parenchymal fibroelastosis on the HRCT Significant pulmonary arterial hypertension: 8.a. Signs of right ventricular failure by echodopplercardiogram or 8.b. Cardiac index < 2L/min/m2 or right heart catheterism

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypersensitivity pneumonitis<br>see elegibility criteria | Other: Disease assessment<br>* A comprehensive evaluation of the disease's extension, its impact on function, quality of life, and the search for phenotype/endotypes will be performed. The association between endotypes and disease progression will be tested.<br>* Other names: K-BILD questionnaire;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in Forced Vital Capacity (FVC) as a continuous variable |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in Computed Tomography Lung Densitometry |  | 24 months | 
| Time to death or lung transplantation |  | 24 months | 
| Acute exacerbation rate |  | 24 months | 
| King´s Brief Interstitial Lung Disease Questionnaire (K-BILD) |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypersensitivity pneumonitis, pulmonary fibrosis, interstitial lung disease