Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 637
- 试验地点
- 65
- 主要终点
- Assessment of the number of patients with cardiac amyloidosis according bon scintigraphy
研究概览
简要总结
Tne aim purpose of this observational, multicentre and propective study is to determine the prevalence of cardiac amyloidosis in geriatric patients aged 80 years and older hospitalized within the last 12 months for heart failure with left ventricular hypertrophy (septum ≥ 12 mm) on echocardiography
详细描述
Patients recruitment will be curry out in 31 geriatric or cardiologic centres.
Patients will be recruited for 24 months. Each patient will participate in the study for 12 months (baseline visit, follow-up phone calls every 3 months up to 12 months i.e., at 3, 6, 9 and 12 months).
The following data will be collected at teh baseline visit: Medical history, demography, clinical data, frailty status assessed by Fried, Triage Risk Screening Tool (TRST), triggers for cardiac decompensation, biological examination, genetic testing, echocardiographic data and other data.
Bone scanning with 99mTc-DPD or 99mTc-HMDP (early or late time with SPECT will be done during hospitalization or after discharge depending on availability at the imaging centre.
The results of each examination will be evaluated to establish the existence and degree of fixation in the myocardium and to determine its distribution.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 80 years
- •Hospitalised for decompensation of heart failure in the last 12 months
- •Subjects with hypertrophy of the septum or left ventricle at cardiac echography (defined as ≥ 12 mm)
- •Subjects able to undergo a bone scintigraphy scan
- •Subjects willing to participate
排除标准
- •Subjects refusing to participate
- •Subjects admitted to palliative care unit.
- •Subjects under guardianship
- •Subjects with a definite diagnosis of cardiac amyloidosis
结局指标
主要结局
Assessment of the number of patients with cardiac amyloidosis according bon scintigraphy
时间窗: At inclusion
次要结局
- Measuring cognitive impairment according Mini-Mental State Examination (MMSE) score(At inclusion)
- Estimating the probability of neuropathic pain according "DN4 Questionnaire"(At inclusion)
- Assessment of commorbidity risk according Charlson Comorbidity Index (CCI)(At inclusion)
- Assessment of the degree of patient dependence according Katz Index of Independence in Activities of Daily Living (ADL)(At inclusion)
- Assessment of Failty status using the Short Emergency Geriatric Assessment (SEGA)(At inclusion)
- Assessment of physical frailty according Fried scale(At inclusion)