心力衰竭和保留射血分数:其进展和预后的观察(HOPP-BERN) (HOPP-BERN)
对每个患者 5 年时间段内射血分数正常的心力衰竭 (HFpEF) 患者的纵向数据、心血管磁共振 (CMR) 成像和健康相关数据进行分析。
在这项研究中,收集了常规临床数据以及 CMR 期间测量的其他研究参数。 CMR 将在整个 5 年随访期间发生。
研究概览
地位
条件
详细说明
射血分数保留的心力衰竭 (HFpEF) 正变得越来越普遍,但该疾病的诊断、特征和预后仍不确定。 多种促成因素与 HFpEF 的发展有关,例如但不限于心肌纤维化、心肌水肿、心室重塑、代谢功能障碍、冠状微血管功能障碍、局部缺血、全身效应和相关的心室-动脉偶联。 然而,这些因素的纵向进展如何与 HFpEF 相关,以及 HFpEF 病理特征之间是否存在因果关系,尚不完全清楚。
使用心血管磁共振 (CMR),可以在一次非侵入性成像检查中研究多个心脏和心外参数。 这将是一个单中心的前瞻性观察纵向研究,并形成一个数据库。 患者将在入组时、入组后 1 年和 5 年以及因心力衰竭再次住院时接受全面的 CMR 检查。 该考试将调查心血管功能、心肌变形、水肿、纤维化和氧合作用、4D 血液动力学评估以及主动脉、肝脏和脾脏的测量等多项指标。 此外,将为患者收集临床数据以创建 HFpEF 数据库(即 患者特征、堪萨斯城心肌病问卷 (KCCQ)、HF 和风险评分、实验室生物标志物、诊断结果)。 通过这项研究,研究人员将能够量化 HFpEF 人群中 CMR 特征的纵向变化,并调查哪些特征与不良预后相关。 收集的数据将有助于更好地了解 HFpEF,并有望显示哪些临床或影像学特征可用于识别并更好地对该异质人群进行风险分层。
研究类型
注册 (估计的)
联系人和位置
学习地点
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Bern、瑞士、3010
- Inselspital, Bern University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
取样方法
研究人群
描述
纳入标准:
- 已知射血分数保留性心力衰竭 (HFpEF)(基于侵入性测量)或 HFpEF 的可能性高(>70%,基于 H2FPEF 评分 ≥4)
- 提供知情同意的能力(项目语言知识),>18 岁
排除标准:
- MRI 不兼容(即。 起搏器、ICD、体内除颤器)
- 急性心肌梗死(<90 天)
- 近期心血管手术或干预(<90 天)
- 严重瓣膜病
- 已知的浸润性疾病(即 淀粉样变性、结节病)
- 已知肥厚型心肌病)
- ARVC(致心律失常性右心室心肌病),非致密化心肌病
- 心脏移植
- 化疗或放疗治疗
- 怀孕
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
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 |
|---|---|---|
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主要不良心血管事件(MACE)的发生率
大体时间:5年内
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综合结果 = 首次因心力衰竭住院或全因死亡率。
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5年内
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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不良临床事件的发生率
大体时间:5年内
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随访期间总不良临床事件的发生率。
不良临床事件定义为:CMR 后心力衰竭住院、ICD 植入、持续性室性心动过速、心源性和非心源性死亡、血运重建治疗、瓣膜修复/置换、心肌梗塞、中风、心绞痛住院。
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5年内
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合作者和调查者
调查人员
- 首席研究员:Christoph Gräni, PD Dr. PhD、Insel Gruppe AG, Inselspital, Universitätsklinik für Kardiologie
- 首席研究员:Kady Fischer, PhD、Insel Gruppe AG, Inselspital, Dept. Anaesthesiology and Pain Medicine
出版物和有用的链接
一般刊物
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有用的网址
研究记录日期
研究主要日期
学习开始 (实际的)
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
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