Dysautonomia in Patients Post COVID-19 Infection
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Heart rate variability
研究概览
简要总结
The aim for this study is further to elucidate the presence of dysautonomia in post-covid-19 patients, by evaluating heart rate variability.
详细描述
The COVID-19 pandemic is currently a serious global public health concern. This disease is caused by a novel coronavirus which was first discovered in Wuhan, China in 2019 and later spread rapidly throughout the world. Symptoms of the disease can manifest as fever, cough, encephalitis, myalgia, fatigue, muscle weakness, arthralgia, anosmia, and impairment in other bodily functions in the acute phase. In 17% to 67% of cases, COVID-19 patients will develop acute respiratory distress syndrome (ARDS) and critical illness. Besides the impact on the respiratory system, coronaviruses have an effect on other systems including the central nervous system, cardiovascular system, musculoskeletal system, and gastrointestinal system.
Potential long-term secondary effects on the musculoskeletal system such as muscle weakness, decreased muscle mass, and myopathies have been brought under attention. Persisting symptoms in patients recovered from COVID-19 infection are frequently a complaint with at least 1 symptom, particularly fatigue and dyspnea. In recent papers, the authors commented on the potential role of dysautonomia in the post-covid-19 entity related to microangiopathy and endothelial injury. Such lesions were already reported in brain biopsy samples of severe COVID-19.
Therefore, the aim of this study is further to elucidate the presence of dysautonomia in post-covid-19 patients, by evaluating heart rate variability.
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
- 否
入选标准
- •Patients with a diagnosed covid-19 infection that took place 2-8 weeks before study inclusion.
- •Cognitive and language functioning enabling coherent communication between the researcher and the participant.
- •French-or Dutch speaking persons.
排除标准
- •Covid-19 infection > 8 weeks ago.
- •The presence of one or more coexisting conditions known to affect HRV analysis (including but not limited to atrial fibrillation, numerous atrial or ventricular extra beats, paced rhythm, left ventricular bundle branch block, cancer, kidney or hepatic failure, and diabetes mellitus)
结局指标
主要结局
Heart rate variability
时间窗: The change between baseline, 3 months (primary time endpoint), 6 months and 12 months
Heart rate variability will be measured using a 2-lead ECG.
次要结局
- Blood volume pulse(The change between baseline, 3 months (primary time endpoint), 6 months and 12 months)
- Respiration rate(The change between baseline, 3 months (primary time endpoint), 6 months and 12 months)
- Electrodermal activity(The change between baseline, 3 months (primary time endpoint), 6 months and 12 months)
- Functionality and disability(The change between baseline, 3 months (primary time endpoint), 6 months and 12 months)
研究者
Moens Maarten
investigator
Universitair Ziekenhuis Brussel