Echocardiographic Characterization of Cardiac Amyloidosis: an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 255
- 试验地点
- 2
- 主要终点
- cardiovascular outcomes
研究概览
简要总结
This is a mono-center observational ambispective study in which patients with cardiac amyloidosis evaluated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Rome, Italy) will be enrolled.
The primary aim is to investigate echocardiographic findings, particularly using advanced echocardiographic techniques, such as two- and three-dimensional speckle-tracking analysis, that may be helpful in the differential diagnosis between cardiac amyloidosis and other cardiomyopathies with hypertrophic phenotype.
Secondary aims are: 1) to evaluate the reversibility of myocardial damage, assessed by echocardiography, in response to a newly available specific treatment for patients with transthyretin-related cardiac amyloidosis (tafamidis) and its correlation with the clinical response 2) to investigate potential novel echocardiographic predictors of adverse cardiovascular outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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 cardiac amyloidosis, defined according to the recommendations provided by the working group of the european society of cardiology, with clinical, electrocardiographic ed echocardiographic data and with at least one follow-up visit.
排除标准
- •missing data
- •decline to the study participation
结局指标
主要结局
cardiovascular outcomes
时间窗: 24 months
composite endpoint of death and heart failure hospitalization
changes in echocardiographic parameters (in patients receiving or not specific treatment)
时间窗: 6 months
variation in global longitudinal strain, diastolic parameters and degree of ventricular hypertrophy
次要结局
- major cardiac arrhythmias(24 months)