HypErsensitiVity PneumonITis: DiseAse Progression Characterization

N/ARecruitingNCT04961944

Hospital do Coracao150 enrolled

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

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Hypersensitivity Pneumonitis

Interventions

Disease assessmentOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (10)

Hospital Prov de Tórax Dr. A. Cetrángolo

Bueno Aires, Argentina

ACTIVE_NOT_RECRUITING

Instituto de Rehabilitacion Psicofisica

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Outcomes

Primary Outcomes

Variation in Forced Vital Capacity (FVC) as a continuous variable

Time frame: 24 months

Secondary Outcomes

Variation in Computed Tomography Lung Densitometry

Time frame: 24 months

Time to death or lung transplantation

Time frame: 24 months

Acute exacerbation rate

Time frame: 24 months

King´s Brief Interstitial Lung Disease Questionnaire (K-BILD)

Time frame: 24 months

Central Contacts

Leticia Kawano-Dourado (PI), MD

CONTACT

+551130536611 ldourado@hcor.com.br

Samara Pinheiro (Project Manager)

CONTACT

scgomes@hcor.com.br

Data from ClinicalTrials.gov

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