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HypErsensitiVity PneumonITis: DiseAse Progression Characterization

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years - 99 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04961944
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hospital do Coracao
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Leticia Kawano Dourado, MDProf. Alexandra Latini, PhD
Principal Investigator Affiliation	HCOR Research Institute, Hospital do Coracao, São Paulo, BrazilFederal University of Santa Catarina
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	Argentina, Brazil, Chile
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Hypersensitivity Pneumonitis

Arms & Interventions

Arms

: Hypersensitivity pneumonitis

see elegibility criteria

Interventions

Other: - Disease 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.

Contact a Trial Team

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