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HypErsensitiVity PneumonITis: DiseAse Progression Characterization (EVITA)

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ClinicalTrials.gov Identifier: NCT04961944
Recruitment Status : Not yet recruiting
First Posted : July 14, 2021
Last Update Posted : July 22, 2021
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Hospital do Coracao

Brief Summary:
EVITA is a multicentric Latin-American prospective study on 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

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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
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : July 1, 2025
Estimated Study Completion Date : October 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Pneumonia

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




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


Secondary Outcome Measures :
  1. Lung Densitometry [ Time Frame: 24 months ]
    Computed Tomography imaging progression

  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 ]
    Health-related quality of Life


Other Outcome Measures:
  1. Tests for interaction: [ Time Frame: 24 months ]
    1. Ag exposure remediation vs non-remediation; Treated vs non-treated HP (antifibrotics); 2. Stratification per sex; 3. Primary outcome dichotomized at loss of FVC >= 10% predicted vs. < 10% , and 4. FVC loss >= 5% vs < 5%.


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


Information from the National Library of Medicine

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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


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 ext 8209 ldourado@hcor.com.br
Contact: Flavia Kojima (Center Manager) +551130536611 ext 8236 fkojima@hcor.com.br

Locations
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Brazil
LABOX - Federal University of Santa Catarina
Santa Catarina, SC, Brazil
LAPOGEN - Federal University of Santa Catarina
Santa Catarina, SC, Brazil
Sponsors and Collaborators
Hospital do Coracao
Boehringer Ingelheim
Investigators
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Principal Investigator: Leticia Kawano Dourado, MD HCOR Research Institute, Hospital do Coracao, São Paulo, Brazil
Study Chair: Juan I Enghelmayer, MD University of Buenos Aires, Buenos Aires, Argentina
Study Chair: María Otaola, MD Instituto de Rehabilitacion Psicofisica, Buenos Aires, Argentina
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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: July 22, 2021
Last Verified: July 2021
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
Disease Attributes
Pathologic Processes
Immune System Diseases
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Respiratory Hypersensitivity
Hypersensitivity, Immediate