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临床试验/NCT07104968
NCT07104968尚未招募不适用

Mild and Moderate Aortic Regurgitation: Risk Factors for Progress and Outcome

Uppsala University1 个研究点 分布在 1 个国家目标入组 35,000 人开始时间: 2025年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
35,000
试验地点
1
主要终点
Progress of aortic regurgitation

研究概览

简要总结

This observational study aims to evaluate risk factors of progress and adverse outcome of aortic regurgitation

详细描述

Aortic regurgitation is relatively common, with a prevalence of 13% for men and 8,5% for women in the Framingham study (Singh et al). Patients with aortic regurgitation are evaluated regularly with echocardiography to see if progress occurs, and suitable candidates are referred for surgical repair or replacement of the aortic valve.

However, an American study from 2019 showed that only 12% of cases of aortic regurgitation progressed from mild to moderate or severe over a 10 years period (Yang et al). This means that the majority of patients undergo echocardiographic evaluations without a clinical benefit.

It is unclear whether these findings also apply to a Swedish population with the European definitions for aortic regurgitation.

Aim:

To do a retrospective analysis of patients evaluated with echocardiography in Västerås, Sweden between January 2003 and March 2025 to describe the prevalence of aortic regurgitation as well as aortic dilatation, to describe how often progress occurs in patients with mild or moderate aortic regurgitation, and finally to look at factors (clinical, echocardiographic) associated with progress of aortic regurgitation as well as outcome (mortality, MACE, cardiac surgery).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients investigated with echocardiography between January 2003 and March 2025
  • Age ≥18 years
  • At least minimal aortic regurgitation
  • At least one additional echocardiography after the index investigation

排除标准

  • Age <18 years

结局指标

主要结局

Progress of aortic regurgitation

时间窗: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up

Progress of aortic regurgitation from mild to moderate or severe, or moderate to severe. Progress is defined according to current European Society for Cardiology guidelines using a comprehensive echocardiographic assessment

次要结局

  • Surgical treatment of aortic regurgitation or aortic aneurysm(Depending on when the patients was evaluated first, up to approximately 20 years of follow-up)
  • Hospitalization for heart failure(Depending on when the patients was evaluated first, up to approximately 20 years of follow-up)
  • Hospitalization for stroke or myocardial infarction(Depending on when the patients was evaluated first, up to approximately 20 years of follow-up)
  • All-cause mortality(Depending on when the patients was evaluated first, up to approximately 20 years of follow-up)

研究者

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

Pär Hedberg

Associate professor

Region Västmanland

研究点 (1)

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