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HypErsensitiVity PneumonITis: DiseAse Progression Characterization (EVITA)

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ClinicalTrials.gov Identifier: NCT04961944
Recruitment Status : Recruiting
First Posted : July 14, 2021
Last Update Posted : June 29, 2023
Sponsor:
Collaborators:
Boehringer Ingelheim
Centro Rossi, Buenos Aires, Argentina
Information provided by (Responsible Party):
Hospital do Coracao

Study Description
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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

Condition or disease Intervention/treatment
Hypersensitivity Pneumonitis Other: Disease assessment

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: HypErsensitiVity PneumonITis: DiseAse Progression Characterization. An International Multicentric Prospective Observational Study
Actual Study Start Date : June 20, 2022
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : March 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Pneumonia

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Variation in Forced Vital Capacity (FVC) as a continuous variable [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Variation in Computed Tomography Lung Densitometry [ Time Frame: 24 months ]
  2. Time to death or lung transplantation [ Time Frame: 24 months ]
  3. Acute exacerbation rate [ Time Frame: 24 months ]
  4. King´s Brief Interstitial Lung Disease Questionnaire (K-BILD) [ Time Frame: 24 months ]

Other Outcome Measures:
  1. Proportion of patients varying FVC >= 10% [ Time Frame: 24 months ]
  2. Variation in meters walked measured by the 6MWT [ Time Frame: 24 months ]
  3. Variation in the ratio dessaturation/meters-walked measured by 6MWT [ Time Frame: 24 months ]
  4. Variation in the dyspnea scores on mMRC scale [ Time Frame: 24 months ]

Biospecimen Retention:   Samples With DNA
Genomic DNA from blood; Blood for protein biomarkers

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with chronic (fibrotic) hypersensitivity pneumonitis
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04961944


Contacts
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Contact: Leticia Kawano-Dourado (PI), MD +551130536611 ldourado@hcor.com.br
Contact: Samara Pinheiro (Project Manager) scgomes@hcor.com.br

Locations
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Argentina
Hospital Prov de Tórax Dr. A. Cetrángolo Active, not recruiting
Bueno Aires, Argentina
Instituto de Rehabilitacion Psicofisica Active, not recruiting
Buenos Aires, Argentina
University of Buenos Aires Active, not recruiting
Buenos Aires, Argentina
Brazil
LABOX - Federal University of Santa Catarina Active, not recruiting
Santa Catarina, SC, Brazil
LAPOGE - Federal University of Santa Catarina Active, not recruiting
Santa Catarina, SC, Brazil
University Hospital HU Professor Polydoro - Federal University of Santa Catarina Active, not recruiting
Florianópolis, Brazil
Centro EDUMED Active, not recruiting
Paraná, Brazil
Hospital do Servidor Estadual de Sao Paulo (IAMPSE) Recruiting
Sao Paulo, Brazil
Contact: Silvia Rodrigues, MD         
InCor - Medical School of the University of Sao Paulo Not yet recruiting
Sao Paulo, Brazil
Contact: Fabio Arimura, MD         
Chile
Instituto Nacional del Tórax Not yet recruiting
Santiago, Chile
Contact: Felipe Reyes, MD         
Contact: Matias Florenzano, MD         
Sponsors and Collaborators
Hospital do Coracao
Boehringer Ingelheim
Centro Rossi, Buenos Aires, Argentina
Investigators
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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
More Information
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Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT04961944    
Other Study ID Numbers: EVITA BI 1199-0430
First Posted: July 14, 2021    Key Record Dates
Last Update Posted: June 29, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital do Coracao:
hypersensitivity pneumonitis
pulmonary fibrosis
interstitial lung disease
Additional relevant MeSH terms:
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Pneumonia
Alveolitis, Extrinsic Allergic
Hypersensitivity
Disease Progression
Immune System Diseases
Disease Attributes
Pathologic Processes
 Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Respiratory Hypersensitivity
Hypersensitivity, Immediate