HypErsensitiVity PneumonITis: DiseAse Progression Characterization

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04961944

Acronym

EVITA

Enrollment

150

Registered

2021-07-14

Start date

2022-06-20

Completion date

2026-03-01

Last updated

2023-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypersensitivity Pneumonitis

Keywords

hypersensitivity pneumonitis, pulmonary fibrosis, interstitial lung disease

Brief summary

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

Interventions

OTHERDisease assessment

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Variation in Forced Vital Capacity (FVC) as a continuous variable	24 months

Secondary

Measure	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

Other

Measure	Time frame
Variation in meters walked measured by the 6MWT	24 months
Variation in the ratio dessaturation/meters-walked measured by 6MWT	24 months
Variation in the dyspnea scores on mMRC scale	24 months
Proportion of patients varying FVC >= 10%	24 months

Countries

Argentina, Brazil, Chile

Contacts

Primary ContactLeticia Kawano-Dourado (PI), MD

ldourado@hcor.com.br+551130536611

Backup ContactSamara Pinheiro (Project Manager)

scgomes@hcor.com.br

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026