HypErsensitiVity PneumonITis: DiseAse Progression Characterization

Hypersensitivity Pneumonitis Clinical Trial

— EVITA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04961944
• Other study ID #: EVITA BI 1199-0430
• Status: Recruiting
• Start date: June 20, 2022
• Est. completion date: March 1, 2026

Study information

• Verified date: June 2023
• Source: Hospital do Coracao
• Contact: Leticia Kawano-Dourado (PI), MD
• Phone: +551130536611
• Email: ldourado[@]hcor.com.br
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolitis, Extrinsic Allergic
• Disease Progression
• Hypersensitivity
• Hypersensitivity Pneumonitis
• Pneumonia

Intervention

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.

Locations

Country	Name	City	State
Argentina	Hospital Prov de Tórax Dr. A. Cetrángolo	Bueno Aires
Argentina	Instituto de Rehabilitacion Psicofisica	Buenos Aires
Argentina	University of Buenos Aires	Buenos Aires
Brazil	University Hospital HU Professor Polydoro - Federal University of Santa Catarina	Florianópolis
Brazil	Centro EDUMED	Paraná
Brazil	LABOX - Federal University of Santa Catarina	Santa Catarina	SC
Brazil	LAPOGE - Federal University of Santa Catarina	Santa Catarina	SC
Brazil	Hospital do Servidor Estadual de Sao Paulo (IAMPSE)	Sao Paulo
Brazil	InCor - Medical School of the University of Sao Paulo	Sao Paulo
Chile	Instituto Nacional del Tórax	Santiago

Sponsors (3)

Lead Sponsor	Collaborator
Hospital do Coracao	Boehringer Ingelheim, Centro Rossi, Buenos Aires, Argentina

Countries where clinical trial is conducted

Argentina,  Brazil,  Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of patients varying FVC >= 10%		24 months
Other	Variation in meters walked measured by the 6MWT		24 months
Other	Variation in the ratio dessaturation/meters-walked measured by 6MWT		24 months
Other	Variation in the dyspnea scores on mMRC scale		24 months
Primary	Variation in Forced Vital Capacity (FVC) as a continuous variable		24 months
Secondary	Variation in Computed Tomography Lung Densitometry		24 months
Secondary	Time to death or lung transplantation		24 months
Secondary	Acute exacerbation rate		24 months
Secondary	King´s Brief Interstitial Lung Disease Questionnaire (K-BILD)		24 months