Screening, Characterization, and Longitudinal Follow-up of Patients With Cardiac Amyloidosis
研究概览
详细说明
This study is designed to longitudinally evaluate patients with cardiac amyloidosis. Patients undergoing clinically indicated diagnostic work-up for amyloidosis prior to initiation of specific therapy.
Participants will undergo comprehensive baseline assessments including resting cardiac MRI, exercise stress MRI, magnetic resonance spectroscopy, pulmonary function testing, cardiopulmonary exercise testing (spiroergometry) as well as blood testing including biomarkers relevant to cardiac amyloidosis (e.g., NT-proBNP, troponin, serum free light chains, immunofixation, and other routine laboratory parameters). Patients will be seen at 3 and 9 months as part of routine clinical care. Study-specific assessments, including imaging and functional testing, will be performed at 6, 12, and 24 months. Imaging, functional and laboratory findings will be correlated with clinical characteristics, laboratory parameters, and treatment over time to improve disease characterization, monitoring, and understanding of disease progression in cardiac amyloidosis.
The study aims to systematically characterize cardiac structure and function, disease phenotype, and clinical status, and to assess their evolution over time. Additional data collected within the study will not influence clinical management and are intended solely for scientific analysis.
The overall objective is to improve understanding of disease progression and treatment effects through comprehensive phenotyping and follow-up in a real-world clinical setting
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Fabian Voß, MD
- 电话号码：02118105187
- 邮箱：ctu@med.uni-duesseldorf.de
研究联系人备份
- 姓名：Saskia Pietrucha, M.Sc.
- 邮箱：ctu@med.uni-duesseldorf.de
学习地点
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North Rhine-Westphalia
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Düsseldorf、North Rhine-Westphalia、德国、40225
- University Hospital Duesseldorf
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接触：
- Saskia Pietrucha, M.Sc.
- 电话号码：+ 49211 81 05187
- 邮箱：ctu@med.uni-duesseldorf.de
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接触：
- Fabian Voß, MD
- 电话号码：02118105187
- 邮箱：ctu@med.uni-duesseldorf.de
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首席研究员：
- Fabian Voß, MD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Age > 18 years
- Male and female patients undergoing clinically indicated diagnostic work-up for amyloidosis or with a previously confirmed diagnosis of cardiac amyloidosis prior to initiation of therapy
- Presence of left ventricular wall thickness > 12 mm on transthoracic echocardiography and at least one "red flag" suggestive of cardiac amyloidosis (according to ESC 2021 criteria) or an otherwise clinically established suspicion of amyloidosis
- Written informed consent
Exclusion Criteria:
- Age < 18 years
- Contraindications to cardiac MRI (e.g., metallic foreign bodies, older-generation pacemakers, severe obesity, claustrophobia)
- Lack of written informed consent for study participation
- Inability to comply with the study procedures
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in myocardial structural parameters
大体时间：after 6 and 12 months
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measured by Cardiac Magnetic Resonance Tomography
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after 6 and 12 months
|
|
Changes in myocardial function
大体时间：after 6 and 12 months
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measured by cardiac magnetic resonance
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after 6 and 12 months
|
|
Changes in myocardial metabolism under therapy
大体时间：after 6 and 12 months
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measured by MR spectroscopy
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after 6 and 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in heart rate reserve
大体时间：after 6 and 12 months
|
measured by functional exercise testing
|
after 6 and 12 months
|
合作者和调查者
调查人员
- 研究主任：Malte Kelm, MD、Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
- 学习椅：Amin Polzin, MD、Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Cardiac Amyloidosis
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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