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临床试验/NCT06129656
NCT06129656招募中不适用

Cardiac Amyloidosis Registry of University Hospital Leipzig

University of Leipzig1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年5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
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

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)

研究者

发起方
University of Leipzig
申办方类型
Other
责任方
Sponsor

研究点 (1)

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