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临床试验/NCT06789211
NCT06789211招募中不适用

Impact of Symptoms and Left Ventricular Systolic Function in Patients With Moderate Mixed Aortic Valve Disease

Leiden University Medical Center1 个研究点 分布在 1 个国家目标入组 1,900 人开始时间: 2024年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,900
试验地点
1
主要终点
All-cause mortality

研究概览

简要总结

Mixed aortic valve disease (MAVD) is defined as the combination of aortic valve stenosis (AS) and regurgitation (AR) and is relatively frequent, with a reported prevalence up to 20-30% of patients with aortic valve disease. Mortality of patients with moderate MAVD (coexistence of both moderate AS and moderate AR) is largely unknown, and therefore there are currently no guidelines-based indications for surgical or transcatheter intervention for these patients, which is considered only when one of the two lesions (AS or AR) becomes severe. Of note, indication for valve intervention in patients with isolated moderate AS is currently under investigation in several randomized clinical trials but only in the presence of relevant symptoms and signs of left ventricular (LV) dysfunction. One initial single-center study including 250 patients with moderate MAVD has evaluated outcomes in this specific subgroup and showed that patients with asymptomatic moderate MAVD and preserved left ventricular ejection fraction (LVEF) had similar adverse event rates (progression to New York Heart Association (NYHA) class III-IV, aortic valve intervention or cardiac death) to patients with isolated asymptomatic severe AS with preserved LVEF. However, the results were primarily driven by the progression of the NYHA Class and aortic valve replacement, and larger multi-center studies are advocated to confirm these findings, which may therefore identify a (new) group of high risk patients who should in principle benefit from an aortic valve intervention as much as patients with isolated severe AS. In addition, prognostic factors (including clinical and echocardiographic characteristics) for risk-stratification of patients with moderate MAVD have not been identified, which may help to refine the indication for valve intervention and optimize patient management.

详细描述

Hypothesis

Patients with moderate MAVD may have similar mortality rates compared to patients with isolated severe AS or severe AR and therefore benefit from aortic valve intervention. The presence of symptoms or impaired LV function may further identify a higher risk group together with other clinical or echocardiographic parameters.

Objectives:

  1. To compare mortality rates in patients with moderate MAVD to isolated severe AS and isolated severe AR in a multi-center setting, adjusting for potential differences in clinical and echocardiographic variables and for the occurrence of aortic valve intervention.
  2. To identify clinical and echocardiographic characteristics associated with increased mortality in this specific population and potentially propose dedicated risk scoring and adjusted cut-off values for the various parameters.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with concomitant moderate AS and moderate AR
  • •Patients with isolated severe AS
  • •Patients with isolated severe AR

排除标准

  • •Previous aortic valve surgery
  • •Concomitant left valvular heart disease more than mild grade
  • •Bad echocardiographic image quality

结局指标

主要结局

All-cause mortality

时间窗: 2003-2024

次要结局

  • All-cause mortality or aortic valve replacement(2003-2024)

研究者

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

Nina Ajmone Marsan

MD, PhD

Leiden University Medical Center

研究点 (1)

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