HypErsensitiVity PneumonITis: DiseAse Progression Characterization

NCT04961944 | Recruiting

• 1 other identifier: EVITA BI 1199-0430
• Study Type: observational
• Target: 150
• Locations: 3 countries
• Sites: 10

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

Conditions

Hypersensitivity Pneumonitis

Keywords

hypersensitivity pneumonitis; pulmonary fibrosis; interstitial lung disease

Outcome Measures

Primary Outcomes (1)

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

  24 months

Secondary Outcomes (4)

• 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 Outcomes (4)

• Proportion of patients varying FVC >= 10%

  24 months

• Variation in meters walked measured by the 6MWT

  24 months

• Variation in the ratio dessaturation/meters-walked measured by 6MWT

  24 months

Study Arms (1)

Hypersensitivity pneumonitis

see elegibility criteria

Other: Disease assessment

Interventions

Disease assessment OTHER

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.

Also known as: Pulmonary function test (PFT), High Resolution Computed Tomography (HRCT) of the Chest, 6-minute walking distance (6MWD), blood for genomics, functional genomics and protein biomarker analysis, urine collection for protein biomarker analysis, Bronchoalveolar fluid collection (in a subset of the sample), K-BILD questionnaire

Hypersensitivity pneumonitis

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with chronic (fibrotic) hypersensitivity pneumonitis

You may qualify if:

• 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).
• Willingness to undergo the evaluations proposed in this protocol
• HP diagnosis within the last 24 months
• Presence of radiological or histological fibrosis:
• a. Radiological fibrosis consists of unequivocal fine or coarse reticulation with architectural lung distortion and/or traction bronchiectasis and/or honeycomb.
• b. Unequivocal histopathological fibrosis evidenced on lung specimens

You may not qualify if:

• Pregnancy
• Presence of established connective tissue disease
• Severe comorbidity impacting on the respiratory system as judged by the attending physician (ex. congestive heart failure, neoplasm, post-COVID-19 sequelae)
• Use of supplemental oxygen at rest
• Dyspnea mMRC 4 (too breathless to leave the house or breathless when dressing or undressing)
• Unequivocal emphysematous pattern of HP on HRCT
• Unequivocal pleuro-parenchymal fibroelastosis on the HRCT
• Significant pulmonary arterial hypertension:
• a. Signs of right ventricular failure by echodopplercardiogram or 8.b. Cardiac index \< 2L/min/m2 or right heart catheterism

Sponsors & Collaborators

• Hospital do Coracao: lead
• Boehringer Ingelheim: collaborator
• Centro Rossi, Buenos Aires, Argentina: collaborator

Study Sites (10)

Hospital Prov de Tórax Dr. A. Cetrángolo

Bueno Aires, Argentina

ACTIVE NOT RECRUITING

Instituto de Rehabilitacion Psicofisica

Buenos Aires, Argentina

ACTIVE NOT RECRUITING

University of Buenos Aires

Buenos Aires, Argentina

ACTIVE NOT RECRUITING

LABOX - Federal University of Santa Catarina

Santa Catarina, Santa Catarina, Brazil

ACTIVE NOT RECRUITING

LAPOGE - Federal University of Santa Catarina

Santa Catarina, Santa Catarina, Brazil

ACTIVE NOT RECRUITING

University Hospital HU Professor Polydoro - Federal University of Santa Catarina

Florianópolis, Brazil

ACTIVE NOT RECRUITING

Centro EDUMED

Paraná, Brazil

ACTIVE NOT RECRUITING

Hospital do Servidor Estadual de Sao Paulo (IAMPSE)

São Paulo, Brazil

RECRUITING

InCor - Medical School of the University of Sao Paulo

São Paulo, Brazil

NOT YET RECRUITING

Instituto Nacional del Tórax

Santiago, Chile

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Genomic DNA from blood; Blood for protein biomarkers

MeSH Terms

Conditions

Alveolitis, Extrinsic Allergic; Pulmonary Fibrosis; Lung Diseases, Interstitial

Interventions

Respiratory Physiological Phenomena; Blood Specimen Collection; Genome; Urine Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Genetic Structures; Genetic Phenomena

Study Officials

• Leticia Kawano Dourado, MD

  HCOR Research Institute, Hospital do Coracao, São Paulo, Brazil

  PRINCIPAL INVESTIGATOR

• Prof. Alexandra Latini, PhD

  Federal University of Santa Catarina

  STUDY CHAIR

Central Study Contacts

Leticia Kawano-Dourado (PI), MD

CONTACT

+551130536611; ldourado@hcor.com.br

Samara Pinheiro (Project Manager)

CONTACT

scgomes@hcor.com.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 14, 2021
• Study Start: June 20, 2022
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: June 29, 2023

Record last verified: 2023-06

Locations

BR (6); AR (3); CL (1)