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HypErsensitiVity PneumonITis: DiseAse Progression Characterization

HypErsensitiVity PneumonITis: DiseAse Progression Characterization

Recruiting
18-99 years
All
Phase N/A

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Overview

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

Eligibility

Inclusion Criteria:

  1. 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).
  2. Willingness to undergo the evaluations proposed in this protocol
  3. HP diagnosis within the last 24 months
  4. 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:
          1. Pregnancy
          2. Presence of established connective tissue disease
          3. Severe comorbidity impacting on the respiratory system as judged by the attending
             physician (ex. congestive heart failure, neoplasm, post-COVID-19 sequelae)
          4. Use of supplemental oxygen at rest
          5. Dyspnea mMRC 4 (too breathless to leave the house or breathless when dressing or
             undressing)
          6. Unequivocal emphysematous pattern of HP on HRCT
          7. Unequivocal pleuro-parenchymal fibroelastosis on the HRCT
          8. 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

Study details
    Hypersensitivity Pneumonitis

NCT04961944

Hospital do Coracao

26 January 2024

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