Cardiac Amyloidosis Registry of University Hospital Leipzig
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- All-cause and cardiac mortality
研究概览
简要总结
This is a clinical registry of patients with cardiac amyloidosis being treated at University Hospital Leipzig. The aim of the registry is to collect detailed information about clinical events, symptoms, imaging, biomarkers, comorbidities, and treatment from routine patient management which would not be provided by randomized clinical trails.
详细描述
Cardiac amyloidosis is increasingly diagnosed since awareness of the disease and therapeutic options increase. There is evidence from clinical trials about warning signs ("red flags"), diagnostic algorithms, and evidence for specific treatment. However, patients in randomized clinical studies are highly selected and do not necessarily reflect clinical practise. Furthermore, large clinical trials do not account for national medical care differences nor provide data about long-term outcome and the associations with comorbidities.
Clinical registries may reflect broad clinical practise and help to characterize cardiac amyloidosis in terms of epidemiology, application of diagnostic methods, the impact of comorbidities, and real-world clinical course. Furthermore, clinical registry studies may validate data from randomized clinical trials, provide information on implementation of treatment, the quality of interventions, monitoring patients during treatment, and inform about the safety of procedures.
The cardiac amyloidosis registry aims to collect data from the routine clinical management of patients with cardiac amyloidosis at the tertiary care University Hospital Leipzig. In particular, obtaining data about clinical events of heart disease, hemodynamic measures from echocardiography and circulation biomarkers, cardiac morphology from different imaging methods, clinical status, functional capacity, quality of life, and impact of comorbidities during the course of the disease will be the goal of this registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed cardiac amyloidosis according to current standards
排除标准
- •refusal to participate
结局指标
主要结局
All-cause and cardiac mortality
时间窗: 10 years
Mortality
Change in high-sensitivity cardiac troponin T over time
时间窗: Every 3-6 months over 10 years
Change in serum concentration of hs-cTnT
Rate of any hospitalizations
时间窗: 10 years
Record of any clinical events requiring hospitalization
Change in left ventricular ejection fraction
时间窗: Every 6-12 months over 10 years
Change in LVEF assessed by echocardiography or cardiac MRI
Change in left ventricular wall thickness
时间窗: Every 6-12 months over 10 years
Change in left ventricular wall thickness/ mass assessed by echocardiography or cardiac MRI
Change in extracellular volume values
时间窗: Approx. every 12 months over 10 years
Change in ECV assessed by cardiac MRI
Changes in medical treatment for heart failure
时间窗: Every 3-6 months over 10 years
Changes in heart failure medication (i.e. diuretics, beta-blocker, renin-angiotensin system inhibitors, mineralocorticoid receptor antagonists, sodium glucose cotransporter type 2 inhibitors) as well as specific treatment for amyloidosis (e.g. tafamidis) is recorded.
Cumulative rate of patients with worsening heart failure
时间窗: 10 years
Heart failure endpoint
Change in systolic arterial pressure
时间窗: Every 6-12 months over 10 years
Change in sPAP assessed by echocardiography
Change in T1 values
时间窗: Approx. every 12 months over 10 years
Change in T1 values assessed by cardiac MRI
Change in N-Terminal Pro-B-Type Natriuretic Peptide over time
时间窗: Every 3-6 months over 10 years
Change in serum concentration of NT-proBNP
次要结局
- Vital signs over time(Every 3-6 months over 10 years)
- Functional capacity over time(Every 3-6 months over 10 years)
- Clinical signs of congestion over time(Every 3-6 months over 10 years)
- Prevalence and incidence of cardiac and non-cardiac comorbidities(Every 3-6 months over 10 years)
- New York Heart Association (NYHA) class over time(Every 3-6 months over 10 years)
- Quality of life over time(Every 3-6 months over 10 years)
- Number of cardiovascular interventions(Monitoring continuously over 10 years)
