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临床试验/NCT05784077
NCT05784077进行中(未招募)不适用

Prevalenza Delle Apnee Notturne e Riduzione Dei Fattori Promotori Nella Fibrillazione Atriale

Istituto Auxologico Italiano1 个研究点 分布在 1 个国家目标入组 343 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
343
试验地点
1
主要终点
Change in prevalence of obstructive sleep apnoea in patients with atrial fibrillation

研究概览

简要总结

This study aims to identify how many patients who have atrial fibrillation, also have sleep apnoea. This is important because sleep apnoea can be a trigger to atrial fibrillation and it can be corrected with a simple intervention. Therefore it is important to understand its prevalence (how many patients with atrial fibrillation are affected by it). Also, obesity and sleep disorders are often associated, therefore the evolution of atrial fibrillation is studied in patients who also have obesity and have lost weight compared with patients who did not loose any weight or are not obese. As medications or therapy are not changed, this is an observational study.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Ejection Fraction <50%
  • HFpEF not related to atrial fibrillation.
  • coronary artery disease
  • valvular cardiomyopathy
  • patient already in treatment for sleep apnoea
  • hyperthyroidism

结局指标

主要结局

Change in prevalence of obstructive sleep apnoea in patients with atrial fibrillation

时间窗: Baseline and at 3, 6, 12, 24 and 36 months

Change in prevalence of obstructive sleep apnoea from baseline to 3 years

Percentage of men and women with obstructive sleep apnoea in patients with atrial fibrillation

时间窗: Baseline

Percentage of men and women with obstructive sleep apnoea in patients with atrial fibrillation

次要结局

  • Change in body weight(Baseline and at 3, 6, 12, 24 and 36 months)
  • Change in incidence of atrial fibrillation recurrencies(Baseline and at 3, 6, 12, 24 and 36 months)
  • Change in quality of life(Baseline and at 3, 6, 12, 24 and 36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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