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临床试验/NCT04689490
NCT04689490已完成不适用

Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients

Hospital Clínico Universitario de Valladolid1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年8月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ignacio J. Amat Santos

Coordinator of Interventional Cardiology Unit

Hospital Clínico Universitario de Valladolid

研究点 (1)

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