NCT04961944招募中不适用
HypErsensitiVity PneumonITis: DiseAse Progression Characterization. An International Multicentric Prospective Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 10
- 主要终点
- Variation in Forced Vital Capacity (FVC) as a continuous variable
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
- •Willingness to undergo the evaluations proposed in this protocol
- •HP diagnosis within the last 24 months
- •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
排除标准
- •Presence of established connective tissue disease
- •Severe comorbidity impacting on the respiratory system as judged by the attending physician (ex. congestive heart failure, neoplasm, post-COVID-19 sequelae)
- •Use of supplemental oxygen at rest
- •Dyspnea mMRC 4 (too breathless to leave the house or breathless when dressing or undressing)
- •Unequivocal emphysematous pattern of HP on HRCT
- •Unequivocal pleuro-parenchymal fibroelastosis on the HRCT
- •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
结局指标
主要结局
Variation in Forced Vital Capacity (FVC) as a continuous variable
时间窗: 24 months
次要结局
- Time to death or lung transplantation(24 months)
- Variation in Computed Tomography Lung Densitometry(24 months)
- Acute exacerbation rate(24 months)
- King´s Brief Interstitial Lung Disease Questionnaire (K-BILD)(24 months)
研究者
研究点 (10)
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