跳至主要内容
临床试验/NCT05010980
NCT05010980招募中不适用

Early Detection of Cardiac Amyloidosis Among Patients With Aortic Valve Stenosis.

Heinrich-Heine University, Duesseldorf1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年8月1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
400
试验地点
1
主要终点
prevalence of cardiac amyloidosis in mild-to-moderate AS

研究概览

简要总结

Due to a lack of therapeutic options, the diagnosis of cardiac (wt)-ATTR amyloidosis was for a long time overshadowed by other diseases and therefore was or still is often diagnosed with considerable delay.

The aim of the study is to estimate the prevalence of cardiac amyloidosis among patients with mild-to-moderate aortic valve stenosis (AS).

Besides that a screening algorithm based on echocardiographic parameters will be developed, to facilitate the early detection of cardiac amyloidosis.

详细描述

Due to a lack of therapeutic options, the diagnosis of cardiac (wt)-ATTR amyloidosis was for a long time overshadowed by other diseases and therefore was or still is often diagnosed with considerable delay. On the one hand, it was assumed that the number of cases was significantly lower than the latest studies showed, and on the other hand, until the introduction of new therapeutic agents, there was no approved therapeutic option available, so that the corresponding diagnosis did not result in any therapeutic consequences.

This has changed fundamentally in recent years. For example, analyses of patients who underwent interventional aortic valve replacement (TAVI) as a result of high-grade AS demonstrated cardiac amyloidosis in up to 16% of these patients. Patients with (paradoxical) low flow low gradient (lflg) AS, which is echocardiographically characterized by a low stroke volume index (SVI), are particularly frequently affected. In light of these data, recent publications recommend the use of a low SVI, in conjunction with ECG criteria (low Sokolow-Lyon index) relative to echocardiographically determined left ventricular myocardial mass (SLI/ LVM) as a screening tool for the presence of amyloidosis in the patient population with high-grade aortic valve stenosis.

In patients with mild-to-moderate AS, the prevalence of amyloidosis and the validity of these methods has not yet been clarified. However, identification of these would be, of particular interest, especially in view of the new therapy options, since with the modern therapy methods can only improve prognosis if the diagnosis is made early.

When cardiac amyloidosis is suspected, three procedures are currently used in clinical practice

  1. myocardial biopsy (BX)
  2. cardiac MRI (CMR)
  3. scintigraphy with 99mTc phosphates as tracer (scintigraphy)

研究设计

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

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Patients who are incapable of giving consent,
  • Age < 65 years
  • patients who have not given their written consent

结局指标

主要结局

prevalence of cardiac amyloidosis in mild-to-moderate AS

时间窗: up to two years

estimating the prevalence of cardiac amyloidosis

次要结局

  • frequency of more rapid progression of AS in patients with cardiac amyloidosis than those without(up to two years)

研究者

发起方
Heinrich-Heine University, Duesseldorf
申办方类型
Other
责任方
Sponsor

研究点 (1)

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