急性心力衰竭的随访:一项前瞻性超声心动图和临床研究(未来) (FUTURE-HIT)
研究概览
详细说明
根据 2016 年欧洲心脏病学会指南,急性心力衰竭 (AHF) 被定义为心力衰竭 (HF) 典型体征和症状的快速发作或快速恶化。 这是一种危及患者生命的临床状况,需要紧急评估和治疗,这通常会导致患者住院。 AHF 是西方国家 65 岁以上人群住院的首位原因,在美国每年住院人数超过 100 万人。 急性发作的 HF 患者的一年再住院率高于慢性 HF (CHF) 患者(30.7 比 22.7)。 在 AHF 病例中,心血管原因导致 23.8% 的病例再入院,而非心血管病例占病例的 8.3%。 新发患者的再住院率低于已知既往心力衰竭患者的再住院率(8.2% 对 21.4%)。 在 CHF 门诊患者中,再住院率约为 22.7%,但只有 8.8% 是由于新发 HF。 我们对 AHF 流行病学的了解主要基于在美国和欧洲进行的各种大规模登记。 这种疾病不仅在死亡率和发病率方面,而且在治疗这些患者所需的资源和基础设施方面都有很多影响,这对国家医疗保健系统构成了沉重的经济负担。 即使随着知识和手段的增加,如今 AHF 的预后仍然很差,并且没有经过证实的疗法可以在降低死亡率方面带来长期益处。 更好地管理失代偿的急性期,包括有效诊断-治疗检查的定义和创新药物的使用,可以改善疾病的进程,对患者产生积极影响(提高生存率和减少入院率),但也对社区(遏制整体健康成本)。 一些研究调查了可能有助于评估 HF 患者心血管事件风险的潜在预后因素,但现在还没有准确和完整的预后评分(包括回忆、临床、实验室和超声心动图参数),特别是对于入院后的 AHF 患者去医院。 近年来,在各种 AHF 设置中概述了许多分数,仅考虑了少量参数。 超声心动图在 HF 患者预后分层中的作用已得到广泛研究。 已经评估了几个超声心动图参数,例如不同心腔的尺寸、左 (LV) 和右心室 (RV) 的舒张功能以及 LV 射血分数 (LVEF)。 已经开发了几种预后模型,每个模型都使用不同的变量组合,这表明评估 AHF 患者的预后有多么困难。 所有这些为开发如此众多的预后模型所做的努力都是有道理的,因为尽管治疗方法不断发展,但再住院的风险以及院内死亡率和出院后死亡率仍然很高。 LVEF 可能是研究最多的参数,并已被证明是 AHF 患者短期和长期死亡率的重要预测指标。 左室顺应性和充盈压也已通过传统的超声心动图进行了广泛研究。 然而,关于 E/e' 比值及其在 AHF 患者中的预后价值的可用数据很少且经常相互矛盾,事实上一些研究表明其缺乏预后价值,而另一些研究表明它可以识别出更高风险的患者死亡和住院,如果结合 LVEF。 另一个需要考虑的重要参数是收缩肺动脉压 (PAP),它已被证明是心血管事件的重要独立预测因子。 最近,几项研究已将新的超声心动图参数纳入这些患者预后的评估中。 斑点追踪超声心动图 (STE) 是一种非侵入性方法,可以独立于声波角度评估心室和心房的整体和局部心室功能。 STE 基于以下观察:超声波束和心肌之间的相互作用会产生声学标记,即定义的散斑,借助专用软件,可以在心动周期中跟踪它们的位移。 LV 纵向应变 (LS) 表示沿其纵轴的心肌缩短,它由收缩期的负曲线和舒张期的正曲线来识别。 LS 在 2、3 和 4 室顶端视图中进行评估:全局 LS (GLS) 由 18 个获得的段的变形峰值的平均值表示。 RV (RVLS) 的 LS 在 4 室心尖视图中获得,感兴趣的部分为 6(3 个用于游离壁,3 个用于室间隔)。 将感兴趣的区域限制在 RV 游离壁的基底、中间和顶端部分,可以分析该壁的 LS,而忽略室间隔。 STE 也已应用于左心房 (LA) 以评估其功能。 识别 LA 的两个纵向应变参数:峰值心房 LS (PALS),在心房储存阶段结束时测量,以及峰值心房收缩应变 (PACS),在主动心房收缩开始之前确定。 近年来,超声在肺部的应用已在急性环境中获得相关性,特别是在通过所谓的 B 线分析确定是否存在充血方面。 后者代表源自胸膜线的彗星伪影,它们垂直向屏幕底部延伸,在呼吸动作期间与肺部的滑动同步移动。 因此,尽管付出了巨大努力,但迄今为止还没有准确的短期和中期预后评分或决定因素可以改善对这些患者的管理,同时请记住,这将允许优化公共支出。 FUTURE 研究人群将前瞻性地招募因 AHF(包括慢性心力衰竭急性加重和首次发作——新发;这两个人群也将分别进行分析)入院的冠脉重症监护病房或心脏病病房的患者。 基本统计分析将评估研究人群的人口统计学、临床和超声心动图参数。 然后,调查将侧重于在收集的参数中确定参数,这些参数在随访期结束时将能够以更高的灵敏度和特异性预测 3 岁时再次住院和/或心血管死亡的风险和 6 个月。 然后根据获得的数据创建一个特定的预后评分,其应用领域将是所有 AHF 住院患者,以预测短期和中期结果。 此外,即使根据 LVEF(如 ESC 指南、HFpEF、HFmrEF、HFpEF 所示)将人群分为 3 组,也将进行统计子分析以评估所选预后参数是否有效。
将在胸骨旁长轴视图中测量 LV 尺寸。 LV 体积、LA 体积和面积将使用 Simpson 双平面法在 2 和 4 心尖腔视图中进行评估,如 ASE 建议中所述。 将使用躯干椭圆体技术从 2D 图像计算 LV 质量。 舒张期将通过从心尖 4 腔视图获得的跨二尖瓣血流的脉冲波多普勒记录进行评估,方法是将样本体积放置在瓣膜小叶尖端的水平。 脉冲组织多普勒成像 (TDI) 将用于测量瓣膜环速度,方法是将样本体积放置在二尖瓣环的横向和间隔角的水平,从心尖 4 腔视图。 随后,收缩压 (s')、早期舒张压 (e') 和晚期 (a') 舒张压速度将通过平均获得的值获得。 E/e' 比率将用作 LV 充盈压力的指标。 二尖瓣环平面收缩偏移将使用标准 M 模式技术进行评估,光标放置在二尖瓣环的侧角。 从 4 腔心尖视图,将在舒张末期和收缩末期测量 RV 面积。 将计算 RV 分数面积变化。 中腔 RV 线性尺寸将在最大基底直径和心尖之间的中间位置测量,在舒张末期的乳头肌水平。 RV 的球形指数将评估为 RV 舒张晚期直径与 RV 纵轴之间的比率。 RV 纵向功能将在三尖瓣外侧环水平使用 TDI 在心尖 4 腔视图中进行评估。 收缩期峰值速度 (s') 将用作 RV 纵向功能的指标,同时通过将光标置于三尖瓣环的侧角,在 M 模式下评估三尖瓣环平面收缩期偏移。 2D-STE 将从常规 2D 灰度图像的 4 和 2 腔心尖视图执行,在短暂的屏气期间并具有稳定的心电图轨迹。 应特别注意获取足够的图像,以便清楚地区分心肌组织和心外结构。 将记录三个连续的心动周期。 帧速率将设置在 40-80 帧/秒之间。 以这种方式获取的图像将使用适当的软件进行处理,并使用基于散斑空间运动的半自动分析应变的方法。 LV GLS、RV 游离壁 LS 和 PALS 的评估将根据 ASE/EAE 共识进行。
研究类型
注册 (实际的)
联系人和位置
学习地点
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Skopje、北马其顿
- University Clinic- Department of Cardiology, St Cyril and Methodius University, R. of North Macedonia
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Mexico City、墨西哥
- National Institute of Cardiology of Mexico Ignacio Chávez
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Athens、希腊
- Laiko General Hospital
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Athens、希腊
- Hygeia Hospital
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Athens、希腊
- Red Cross Hospital
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Elefsína、希腊
- General Hospital of Elefsina Thriassio
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Kallithéa、希腊
- Onassis Cardiac Surgery Center
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Piraeus、希腊
- Tzaneion General Hospital
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Thessaloníki、希腊
- 1st Cardiology Department, AHEPA University Hospital
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Thessaloníki、希腊
- Hippokrateion University Hospital, Medical School, Aristotle University of Thessaloniki, Third Cardiology Department
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Milan、意大利
- Centro Cardiologico Monzino IRCCS, Department of Cardiovascular Imaging
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Modena、意大利
- Division of Cardiology, Nephro-Cardiovascular Department, "S. Agostino- Estense" Public Hospital, University of Modena and Reggio Emilia
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Napoli、意大利
- Division of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", Caserta; Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli"
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Napoli、意大利
- Federico II" University Hospital
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Novara、意大利
- Dipartimento Toraco-Cardio-Vascolare, AOU Maggiore della Carità, Università del Piemonte Orientale
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Palermo、意大利
- Cardiology Unit, Department of Excellence of Sciences for Health Promotion and Mothernal-Child Care, Internal Medicine and Specialities (ProMISE), University of Palermo, University Hospital Paolo Giaccone
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Piacenza、意大利
- Unità Operativa di Cardiologia, Ospedale Guglielmo da Saliceto
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Pisa、意大利
- Division of Cardiology; Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, AOUP
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Pisa、意大利
- Fondazione Toscana G. Monasterio
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Salerno、意大利
- Division of Cardiology - Nocera Inferiore Hospital and L. Vanvitelli University
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Salerno、意大利
- Heart Department, AOU S. Giovanni e Ruggi, Salerno, Italy.
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Siena、意大利
- Department of Medical Biotechnologies Division of Cardiology University of Siena
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Edegem、比利时
- Department of Cardiology, Antwerp University Hospital
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Sydney、澳大利亚
- Blacktown Hospital, Faculty of Medicine, University of Sydney
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Ankara、火鸡
- Gazi University
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Istanbul、火鸡
- Dr Siyami Ersek Cardiothoracic Surgery Center
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La Marsa、突尼斯
- Department of Cardiology, FSI Hospital
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Bucharest、罗马尼亚
- Emergency Central Militar Hospital
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Amsterdam、荷兰
- Department of Cardiology, Amsterdam University Medical Center
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Porto、葡萄牙
- Centro Hospitalar Universitário de São João
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Barcelona、西班牙
- Hospital Vall d'Hebron
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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
有资格学习的性别
取样方法
研究人群
描述
纳入标准:
- 年龄≥18岁
- 根据当前 ESC 指南中的临床和仪器标准,因急性心力衰竭(新发或慢性心力衰竭恶化)进入心脏病科
- 签署知情同意书
排除标准:
- 年龄 < 18 岁
- 人工瓣膜
- 以前的心脏移植或 LVAD
- 隔音窗差。
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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心力衰竭和心血管死亡再入院的预测因子
大体时间:出院后 3 个月和 6 个月
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FUTURE HIT 研究的主要终点将是评估入院后 24 小时内和出院前评估的临床、实验室和超声心动图变量中的最佳参数,这些参数能够预测 3 岁时因 HF 和心血管死亡的再入院情况和 6 个月,在因 CHF 急性加重或新发 AHF 入院心脏病科的患者中。
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出院后 3 个月和 6 个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
心力衰竭和心血管死亡的再住院联合预后评分
大体时间:出院后 3 个月和 6 个月
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使用在多中心基础上对主要终点具有统计学意义的参数,创建组合预后无量纲评分。
更高的分数意味着更差的结果。
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出院后 3 个月和 6 个月
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根据心力衰竭的不同类别(HFpEF、HFmrEF、HFrEF)进行事件分析
大体时间:出院后 3 个月和 6 个月
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分析事件和参数的预测能力,这些参数对指南中指出的心力衰竭不同类别(HFpEF、HFmrEF、HFrEF)的主要终点具有统计学意义;
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出院后 3 个月和 6 个月
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按流派的事件分析
大体时间:出院后 3 个月和 6 个月
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分析两个流派中参数的事件和预测能力
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出院后 3 个月和 6 个月
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合作者和调查者
调查人员
- 首席研究员:Matteo Cameli, Prof、Department of Medical Biotechnologies Division of Cardiology University of Siena
出版物和有用的链接
一般刊物
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