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临床试验/NCT04859894
NCT04859894Unknown不适用

Lung Function, Heart Function and Aerobic Capacity in Patients Suffering From Long-term Symptoms Following SARS-CoV2-infection, and the Association With DNA Methylation

Linkoeping University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年4月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
Peak Oxygen Consumption (VO2peak)

研究概览

简要总结

The physiological derangements in subjects suffering from long-term symptoms following a Covid-19 infection (Post-COVID-19 Syndrome) are poorly understood and evaluated. This study will recruit subjects with a clinical diagnosis of Post-Covid-19-syndrome) who are scheduled for either of lung function testing, cardiopulmonary exercise testing or cardiac ultrasound. Patients' symptoms will be correlated to physiological measures and compared to predicted values. In addition, in 20 patients, symptoms and physiological measures will be correlated to epigenetical alterations, or DNA-methylation patterns. In addition, a subset of patients will be examined a year after the baseline testing in order to follow the progress of the disease.

详细描述

The physiological derangements in subjects suffering from long-term symptoms following a Covid-19 infection (Post-COVID-19 Syndrome) are poorly understood and evaluated. For example, the extent to which subjective symptoms correlate with physiological impairments are not known.

This study will recruit subjects with a clinical diagnosis of Post-Covid-19-syndrome) who are scheduled for either of lung function testing, cardiopulmonary exercise testing or cardiac ultrasound. Patients' symptoms will be correlated to physiological measures and compared to predicted values.

In addition, in 20 patients, symptoms and physiological measures will be correlated to epigenetical alterations, or DNA-methylation patterns. In addition, a subset of patients will be examined a year after the baseline testing in order to follow the progress of the disease.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Confirmed or clinically highly suspected Covid19-infection
  • Symptom duration at least 12 weeks following first occurence of symptoms
  • No other disease that better could explain the symptoms than Covid19

排除标准

  • Age <18 years
  • Unability to perform a maximal exercise test
  • Unability to understand written or spoken Swedish

结局指标

主要结局

Peak Oxygen Consumption (VO2peak)

时间窗: At baseline

Cross-sectional evaluation of VO2peak and the association with symptoms

次要结局

  • Peak Oxygen Consumption (VO2peak)(In subset of subjects at 1 year)
  • VE/VCO2-slope(At baseline, in subset at 1 year)
  • Diffusion Capacity (DLCOc)(At baseline, in subset at 1 year)
  • Forced Expiratory Volume in 1 second (FEV1)(At baseline, in subset at 1 year)
  • Forced Vital Capacity (FVC)(At baseline, in subset at 1 year)
  • Total Lung Capacity (TLC)(At baseline, in subset at 1 year)

研究者

发起方
Linkoeping University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Kristofer Hedman

Associate Professor

Linkoeping University

研究点 (1)

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