Clinical trial NCT04961944: HypErsensitiVity PneumonITis: DiseAse Progression Characterization
Official title: HypErsensitiVity PneumonITis: DiseAse Progression Characterization. An International Multicentric Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypersensitivity Pneumonitis
Keywords: hypersensitivity pneumonitis
pulmonary fibrosis
interstitial lung disease
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
name: Centro Rossi, Buenos Aires, Argentina
First posted: 2021-07-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with chronic (fibrotic) hypersensitivity pneumonitis

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


Eligibility 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

Primary outcomes:
measure: Variation in Forced Vital Capacity (FVC) as a continuous variable
timeFrame: 24 months
Secondary outcomes:
measure: Variation in Computed Tomography Lung Densitometry
timeFrame: 24 months
measure: Time to death or lung transplantation
timeFrame: 24 months
measure: Acute exacerbation rate
timeFrame: 24 months
measure: King´s Brief Interstitial Lung Disease Questionnaire (K-BILD)
timeFrame: 24 months
Other outcomes:
measure: Proportion of patients varying FVC >= 10%
timeFrame: 24 months
measure: Variation in meters walked measured by the 6MWT
timeFrame: 24 months
measure: Variation in the ratio dessaturation/meters-walked measured by 6MWT
timeFrame: 24 months
measure: Variation in the dyspnea scores on mMRC scale
timeFrame: 24 months
Locations:
city: Bueno Aires
country: Argentina
facility: Hospital Prov de Tórax Dr. A. Cetrángolo
city: Buenos Aires
country: Argentina
facility: Instituto de Rehabilitacion Psicofisica
city: Buenos Aires
country: Argentina
facility: University of Buenos Aires
city: Santa Catarina
country: Brazil
facility: LABOX - Federal University of Santa Catarina
state: SC
city: Santa Catarina
country: Brazil
facility: LAPOGE - Federal University of Santa Catarina
state: SC
city: Florianópolis
country: Brazil
facility: University Hospital HU Professor Polydoro - Federal University of Santa Catarina
city: Paraná
country: Brazil
facility: Centro EDUMED
city: Sao Paulo
country: Brazil
facility: Hospital do Servidor Estadual de Sao Paulo (IAMPSE)
city: Sao Paulo
country: Brazil
facility: InCor - Medical School of the University of Sao Paulo
city: Santiago
country: Chile
facility: Instituto Nacional del Tórax
Study officials:
affiliation: HCOR Research Institute, Hospital do Coracao, São Paulo, Brazil
name: Leticia Kawano Dourado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Santa Catarina
name: Prof. Alexandra Latini, PhD
role: STUDY_CHAIR
References: