Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Left Ventricular (LV) Function
研究概览
简要总结
We conducted a national, single center (Hospital Clínico Universitario de Valladolid, Spain, Valladolid), prospective study of patients with prior hospitalization because of COVID-19 who were admitted between March 1st, 2020, and May 15th, 2020. All eligible patients underwent at least at first-time follow-up from the index event. Exclusion criteria were age < 18 years old, pregnant women, terminally ill patients, active SARS-CoV-2 infections, inability to exercise and previous known severe pulmonary or heart disease. Patients underwent a clinical assessment for symptom burden, questionnaire for quality of life (Kansas City Cardiomyopathy Questionnaire and SF-36), venous blood sampling, 6-minute walking test (6-MWT), tests of lung function (spirometry and diffusing capacity of the lungs for carbon monoxide) and treadmill cardio-pulmonary exercise testing (CPET). 48-hours before the test of lung function and the CPET, all patients yielded a negative result in the reverse transcription-polymerase chain reaction (RT-PCR) for SARS-CoV-2. For definitive analysis patients were assigned to the control group if they did not refer dyspnea at the time of the follow-up, a small asymptomatic out-patient control group without prior hospitalization was also included.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent
- •Previous COVID-19 hospitalization with successful discharged
- •Availability of at least one follow up per clinical protocol
排除标准
- •pregnant women
- •terminally ill patients
- •active SARS-CoV-2 infections
- •inability to exercise
- •previous known severe pulmonary or heart disease
结局指标
主要结局
Left Ventricular (LV) Function
时间窗: 6 months
Left Ventricular (LV) Function (Ecocardiagraphy-measured Cardiac Function)
Aerobic capacity
时间窗: 6 months
Measured as peak oxygen uptake
Total Lung Capacity (TLC)
时间窗: 6 months
Pulmonary function test
Force Expiratory Volume in 1 second (FEV1)
时间窗: 6 months
Pulmonary function test
Difussing Lung Capacity of CO (DLCO)
时间窗: 6 months
Pulmonary function test
Forced Vital Capacity (FVC)
时间窗: 6 months
Pulmonary function test
Right Ventricular (RV) Function
时间窗: 6 months
Right Ventricular (RV) Function (Ecocardiagraphy-measured Cardiac Function)
次要结局
- D-Dimer(6 months)
- Short Form 36 Health Survey (SF-36)(6 months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(6 Months)
- interleukine-6(6 months)
- 6 Minute Walk Test(6 months)
- N-terminal pro hormone B-type natriuretic peptide (NT-proBNP)(6 months)
- Troponin-T(6 months)
- Ferritin(6 months)
- C reactive protein (CRP)(6 months)
研究者
Ignacio J. Amat Santos
Coordinator of Interventional Cardiology Unit
Hospital Clínico Universitario de Valladolid
