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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
| Centro Rossi, Buenos Aires, Argentina | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypersensitivity pneumonitis | see elegibility criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disease assessment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in Forced Vital Capacity (FVC) as a continuous variable | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in Computed Tomography Lung Densitometry | 24 months | |
| Time to death or lung transplantation | 24 months | |
| Acute exacerbation rate |
| Measure | Description | 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 |
Inclusion Criteria:
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:
8.a. Signs of right ventricular failure by echodopplercardiogram or 8.b. Cardiac index < 2L/min/m2 or right heart catheterism
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Adult patients with chronic (fibrotic) hypersensitivity pneumonitis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leticia Kawano-Dourado (PI), MD | Contact | +551130536611 | ldourado@hcor.com.br | |
| Samara Pinheiro (Project Manager) | Contact | scgomes@hcor.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Leticia Kawano Dourado, MD | HCOR Research Institute, Hospital do Coracao, São Paulo, Brazil | Principal Investigator |
| Prof. Alexandra Latini, PhD | Federal University of Santa Catarina | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Prov de Tórax Dr. A. Cetrángolo | Active, not recruiting | Bueno Aires | Argentina | |||
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| ID | Term |
|---|---|
| D000542 | Alveolitis, Extrinsic Allergic |
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| D012143 | Respiratory Physiological Phenomena |
| D001800 | Blood Specimen Collection |
| D016678 | Genome |
| D059349 | Urine Specimen Collection |
| ID | Term |
|---|---|
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Genomic DNA from blood; Blood for protein biomarkers
|
| 24 months |
| King´s Brief Interstitial Lung Disease Questionnaire (K-BILD) | 24 months |
| 24 months |
| Variation in the dyspnea scores on mMRC scale | 24 months |
| Instituto de Rehabilitacion Psicofisica |
| Active, not recruiting |
| Buenos Aires |
| Argentina |
| University of Buenos Aires | Active, not recruiting | Buenos Aires | Argentina |
| LABOX - Federal University of Santa Catarina | Active, not recruiting | Santa Catarina | Santa Catarina | Brazil |
| LAPOGE - Federal University of Santa Catarina | Active, not recruiting | Santa Catarina | Santa Catarina | 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 | São Paulo | Brazil |
|
| InCor - Medical School of the University of Sao Paulo | Not yet recruiting | São Paulo | Brazil |
|
| Instituto Nacional del Tórax | Not yet recruiting | Santiago | Chile |
|
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |