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临床试验/NCT06930989
NCT06930989已完成不适用

Twin Threat of OSA and Hypertension on Mortality/CV-risk and Protective Effect by Positive Airway Pressure Treatment.

Vastra Gotaland Region1 个研究点 分布在 1 个国家目标入组 148,467 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
148,467
试验地点
1
主要终点
Major cardiovascular event (MACE)

研究概览

简要总结

Hypertension and obstructive sleep apnea (OSA) are both common conditions that independently increase the risk cardiovascular disease including atrial fibrillation, ischemic heart disease, heart failure and stroke. OSA is also an independent promoter of hypertension development and poorly controlled hypertension is overrepresented in OSA. Finally, HT and OSA share many risk factors including obesity, and several lifestyle factors. Altogether, these links contribute to a high prevalence of patients with both disorders.

The investigators suspect participants with HT and OSA are at even higher CV risk and may get their first CV event earlier in life. Comparison between HT and OSA participants vs HT alone, OSA alone or healthy controls has not previously been investigated in large studies.

Thus, the investigators aim to investigate long-term risk of major cardiovascular events (MACE) or death comparing these groups in registry data between 2010-2022 in Sweden. The investigators will also investigate the protecting effect of positive airway pressure (PAP) on the OSA related CV risk increase and how many hours/night of PAP use is needed to get any protective effects.

详细描述

Please see attached analysis plan

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

  • Adult patients starting PAP treatment for OSA in the swedevox registry between 2010-2021 with and without hypertension. Randomly selected controls with and without hypertension from the general population.

排除标准

  • Patients with manifest cardiovascular disease (stroke, ischemic heart disease, cardiac failure or atrial fibrillation at baseline).
  • Patients with kidney failure at baseline.
  • Patients with malignant cancer at baseline.
  • Subjects with missing data on any of the main variables in the fitted models.

结局指标

主要结局

Major cardiovascular event (MACE)

时间窗: First event during follow-up 2010-2022

Major cardiovascular event (MACE) including CV death

Age at first MACE

时间窗: First event during follow-up 2010-2022

mean age at first MACE for the groups

All cause death

时间窗: 2010-2022

death from any cause during follow-up

次要结局

  • Risk reduction with PAP(2010-2022)

研究者

发起方
Vastra Gotaland Region
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sven Svedmyr

MD, principal investigator

Vastra Gotaland Region

研究点 (1)

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