HypErsensitiVity PneumonITis: DiseAse Progression Characterization (EVITA)

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

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 Overview

• Status: Recruiting
• Conditions: Hypersensitivity Pneumonitis
• Intervention / Treatment: Other: Disease assessment

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Leticia Kawano-Dourado (PI), MD; Phone Number: +551130536611; Email: ldourado@hcor.com.br
• Study Contact Backup: Name: Samara Pinheiro (Project Manager); Email: scgomes@hcor.com.br

Study Locations

• Argentina
  • Bueno Aires, Argentina
    • Active, not recruiting
    • Hospital Prov de Tórax Dr. A. Cetrángolo
  • Buenos Aires, Argentina
    • Active, not recruiting
    • Instituto de Rehabilitacion Psicofisica
  • Buenos Aires, Argentina
    • Active, not recruiting
    • University of Buenos Aires
• Brazil
  • Florianópolis, Brazil
    • Active, not recruiting
    • University Hospital HU Professor Polydoro - Federal University of Santa Catarina
  • Paraná, Brazil
    • Active, not recruiting
    • Centro EDUMED
  • Sao Paulo, Brazil
    • Recruiting
    • Hospital do Servidor Estadual de Sao Paulo (IAMPSE)
    • Contact: Silvia Rodrigues, MD
  • Sao Paulo, Brazil
    • Not yet recruiting
    • InCor - Medical School of the University of Sao Paulo
    • Contact: Fabio Arimura, MD
  • SC
    • Santa Catarina, SC, Brazil
      • Active, not recruiting
      • LABOX - Federal University of Santa Catarina
    • Santa Catarina, SC, Brazil
      • Active, not recruiting
      • LAPOGE - Federal University of Santa Catarina
• Chile
  • Santiago, Chile
    • Not yet recruiting
    • Instituto Nacional del tórax
    • Contact: Felipe Reyes, MD
    • Contact: Matias Florenzano, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with chronic (fibrotic) hypersensitivity pneumonitis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Hypersensitivity pneumonitis; see elegibility criteria

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.; Other Names: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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
Variation in the dyspnea scores on mMRC scale	24 months

Collaborators and Investigators

• Sponsor: Hospital do Coracao
• Collaborators: Boehringer Ingelheim; Centro Rossi, Buenos Aires, Argentina
• Investigators: Principal Investigator: Leticia Kawano Dourado, MD, HCOR Research Institute, Hospital do Coracao, São Paulo, Brazil; Study Chair: Prof. Alexandra Latini, PhD, Federal University of Santa Catarina

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: interstitial lung disease; pulmonary fibrosis; hypersensitivity pneumonitis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Disease Attributes; Respiratory Hypersensitivity; Lung Diseases, Interstitial; Hypersensitivity; Disease Progression; Pneumonia; Alveolitis, Extrinsic Allergic
• Other Study ID Numbers: EVITA BI 1199-0430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No