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HypErsensitiVity PneumonITis: DiseAse Progression Characterization

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

NCT04961944•Hospital do Coracao

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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

Eligibility

Age

18 - 99 years

Sex

ALL

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

Locations (10)

Hospital Prov de Tórax Dr. A. Cetrángolo

Bueno Aires, Argentina

Instituto de Rehabilitacion Psicofisica

Buenos Aires, Argentina

University of Buenos Aires

Buenos Aires, Argentina

LABOX - Federal University of Santa Catarina

Santa Catarina, Santa Catarina, Brazil

LAPOGE - Federal University of Santa Catarina

Santa Catarina, Santa Catarina, Brazil

University Hospital HU Professor Polydoro - Federal University of Santa Catarina

Florianópolis, Brazil

Centro EDUMED

Paraná, Brazil

Hospital do Servidor Estadual de Sao Paulo (IAMPSE)

São Paulo, Brazil

InCor - Medical School of the University of Sao Paulo

São Paulo, Brazil

Instituto Nacional del Tórax

Santiago, Chile

Key Dates

Start Date

June 20, 2022

Primary Completion Date

December 1, 2025

Completion Date

March 1, 2026

Last Updated

June 29, 2023

Enrollment

150

ESTIMATED participants

Conditions

Hypersensitivity Pneumonitis

Interventions

Disease assessment

OTHER

Contacts

Leticia Kawano-Dourado (PI), MD

CONTACT

+551130536611 ldourado@hcor.com.br

Samara Pinheiro (Project Manager)

CONTACT

scgomes@hcor.com.br

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

HypErsensitiVity PneumonITis: DiseAse Progression Characterization

Inclusion Criteria

Exclusion Criteria

Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis

Prognostic Score Comparison in IPF and HP

Assessing Health Related Quality of Life in Hypersensitivity Pneumonitis

This Study Aim is to Compare the Effect of Oral Methyl Prednisolone on Different Radiological Patterns of Hypersensitivity Pneumonitis as it Was Found That Not All Patients Get Satisfying Therapeutic Effect After Taking Corticosteroids.