MitraClip 装置在具有临床意义的功能性二尖瓣反流的心力衰竭患者中的随机研究 (RESHAPE-HF)
2018年11月5日 更新者：Abbott Medical Devices
该试验是一项针对 MitraClip 装置在具有临床显着功能性二尖瓣反流的心力衰竭患者中进行的随机研究。
假设与单独的最佳标准护理治疗相比，除了最佳标准药物治疗外，使用 MitraClip 装置的全因死亡率和复发性心力衰竭住院的分层复合发生率较低。
研究概览
详细说明
本研究是对 MitraClip 系统治疗慢性心力衰竭患者具有临床意义的功能性二尖瓣反流的安全性和有效性的临床评估。 目的是进一步研究 MitraClip 系统治疗纽约心脏协会功能性 III 级或 IV 级慢性心力衰竭患者临床显着功能性二尖瓣反流的安全性和有效性。
由于招募率低于预期，雅培血管对该试验的赞助提前终止。
研究类型
介入性
注册 (实际的)
42
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Aarhus、丹麦
- Skejby Sykehus/Aarhus University Hospital
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Copenhagen、丹麦
- Rigshospitalet
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Odense、丹麦
- Odense Universitetshospital
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Fadingerstraße 1
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Linz、Fadingerstraße 1、奥地利、A-4020
- Allgemein öffentliches Krankenhaus Elisabethinen Linz
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Aachen、德国
- Universitätsklinikum der RWTH - Aachen
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Bad Krozingen、德国
- Herz-Zentrum
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Berlin、德国
- Charité - Universitätsmedizin Berlin
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Bernau、德国
- Evangelish-Freikirchliches Krankenhaus, Bernau
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Göttingen、德国
- Herzzentrum Göttingen Universitätsmedizin, Göttingen
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Hamburg、德国
- Asklepios Klinik St Georg, Hamburg
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Hamburg、德国
- Kardiologische Gemeinschaftspraxis Mathey-Schofer, Hamburg
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Hamburg、德国
- Universitäre Herzzentrum, Hamburg
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Heidelberg、德国
- Uni-Klinikum Heidelberg
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Mainz、德国
- Johannes Gütenberg University, Mainz
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Brescia、意大利
- Spedali Civili di Brescia
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Catania、意大利
- Ospedale Ferrarotto Alessi, Catania
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Milano、意大利
- Centro Cardiologico Monzino
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Milano、意大利
- Ospedale San Raffaele, Milano
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Pisa、意大利
- Azienda Ospedaliero Universitaria Pisana, Pisa
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Edegem、比利时
- UZA
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Stockholm、瑞典
- Karolinska University Hospital, Stockholm
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Basel、瑞士
- Universitätsspital Basel
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Bern、瑞士
- Inselspital Bern
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Zürich、瑞士
- Universitäts Spital Zürich
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Helsinki、芬兰
- Helsinki University Hospital
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Amsterdam、荷兰
- Academisch Medisch Centrum
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Leeuwarden、荷兰
- Medisch Centrum Leeuwarden
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Nieuwegein、荷兰
- St Antonius Ziekenhuis, Nieuwegein
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Barcelona、西班牙
- Hospital Sant Creu y Sant Pau,
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 年龄在18岁至90岁之间
- 根据欧洲超声心动图协会的定义，在随机分组前 90 天内出现临床显着的功能性二尖瓣反流（中度至重度或重度二尖瓣反流），并由超声心动图核心实验室确认
- 经研究者评估，在随机化前的最后 2 周内，至少 4 周内心力衰竭药物的剂量没有变化（利尿剂除外）
- 随机化前 90 天内，纽约心脏协会 III 级或 IV 级心力衰竭记录，尽管采用了最佳护理标准
- 随机化前 12 个月内至少有一次心力衰竭住院记录（急诊入院或急诊室就诊）或最佳医疗后 BNP 值至少 350 pg/mL 或 NT-proBNP 值至少 1400 pg/mL 和/或随机分组前 90 天内的设备管理
- 左心室射血分数 (LVEF) ≥ 15% 且 ≤ 40% 在随机分组前 90 天内通过经胸超声心动图确定并由超声心动图核心实验室确认
- 左心室舒张末期直径 (LVEDD) ≥ 55 mm，在随机分组前 90 天内通过经胸超声心动图确定，并由超声心动图核心实验室确认
- 患者可以走动并能够进行 6MWT，唯一的限制因素是心血管健康
- 受试者同意返回进行所有必要的术后随访
- 受试者已被告知研究的性质并同意研究的规定，包括随机分配到对照组的可能性，并已提供经相应临床研究中心伦理委员会批准的书面知情同意书
排除标准：
- 二尖瓣反流主要是由于二尖瓣装置的退行性疾病（退行性二尖瓣反流），经食管超声心动图确定
- 状态 1 心脏移植或既往原位心脏移植
- 在随机分组前的最后 4 周内引入新的心力衰竭药物类别
- 随机分组前最后 2 周内因心血管疾病住院
- 随机分组前 90 天内有急性冠脉综合征、短暂性脑缺血发作或中风的证据
- 随机分组前 90 天内进行过任何经皮心血管介入治疗、颈动脉手术、心血管手术或心房颤动消融术
- 在随机分组前 90 天内植入任何节律管理装置（即起搏器、心脏再同步化治疗，有或没有心律转复除颤器（CRT 或 CRT-D）或植入式心律转复除颤器 (ICD)，或任何植入的节律管理装置的修订随机分组前 90 天内
- 需要任何心血管手术
- 二尖瓣手术被认为是受试者的一种治疗选择
- 肾脏替代疗法
- 未控制的高血压（即收缩压 >180 mmHg 和/或舒张压 >105 mmHg）或低血压（即收缩压 <90 mmHg）
- 研究者判断为不稳定型心绞痛、其他有临床意义的未矫正瓣膜病或左心室流出道梗阻、阻塞性心肌病、控制不佳的快速心房颤动或扑动、控制不佳的症状性心动过缓或快速性心律失常
- 6MWT距离>450米
- 二尖瓣面积 (MVA) 通过面积测量 <4.0 cm2；如果无法通过面积测量法测量 MVA，则可以接受压力半衰期测量； MVA 必须由超声心动图核心实验室确认
可能妨碍 MitraClip 装置植入、装置在瓣叶上的正确定位或充分减少二尖瓣反流的瓣叶解剖结构可能包括：
- 抓握区域钙化的证据
- 抓握区域存在明显裂缝
- 抓握区域缺乏初级和次级弦支持
- 既往二尖瓣手术
- 接合长度≤2 mm
- 小叶活动长度 <1 cm
- 股静脉中存在会干扰输送导管的 IVC 过滤器，或存在同侧深静脉血栓形成 (DVT)
- 经房间隔插管术的禁忌症
- 禁忌经食管超声心动图检查的受试者
- 心脏内肿块、血栓或赘生物的超声心动图证据
- 活动性心内膜炎或活动性风湿性心脏病或因风湿性疾病退化的小叶（即不顺应、穿孔）
存在以下任何一项：
- 严重的主动脉瓣狭窄（主动脉瓣面积<1.0 cm2）或严重的主动脉瓣关闭不全
- 浸润性心肌病（例如，淀粉样变性、血色素沉着症、结节病）
- 肥厚性心肌病、限制性心肌病、缩窄性心包炎或任何其他导致心力衰竭的结构性心脏病，但缺血性或非缺血性病因的扩张型心肌病除外
- 血流动力学不稳定需要正性肌力支持或机械心脏循环支持
- 需要当前抗生素治疗的活动性感染
- 已知对无法在医学上充分管理的程序性药物过敏或禁忌症
- 严重的右心室衰竭或严重的三尖瓣反流
- 出血素质或凝血病史或拒绝输血的受试者
- 怀孕或计划在未来 12 个月内怀孕。 注意：有生育能力的女性患者需要在随机分组前 14 天内进行阴性妊娠试验，并遵守公认的避孕方法
- 研究者判断预期寿命不足 12 个月的并发疾病
- 目前正在参与另一项治疗性或介入性心力衰竭试验，或任何未经批准的药物或设备的试验（参与观察性研究或注册的受试者可能被视为符合条件）
- 根据研究者的判断，受试者属于弱势群体，或者受试者患有任何类型的疾病，会影响他/她给予书面知情同意和/或遵守研究程序的能力
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：MitraClip 装置
除了最佳标准药物治疗外，随机分配到设备组的受试者还将接受 MitraClip 手术。
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MitraClip 系统包括一个 MitraClip 装置、一个可操纵的引导导管和一个 MitraClip 输送系统，可以将 MitraClip 装置放置在二尖瓣小叶上
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无干预：控制
随机分配到对照组的受试者将单独接受最佳标准护理治疗。
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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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全因死亡率和复发性心力衰竭住院的分层复合
大体时间：两年
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分析将在最后一名患者完成 12 个月的随访时进行。
分析中将包括长达 24 个月的所有随访。
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两年
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次要结果测量
结果测量 |
大体时间 |
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30 天时设备组的全因死亡率、中风、心肌梗死、肾脏替代治疗的新需求以及设备相关并发症的非选择性心血管手术的综合
大体时间：30天
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30天
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12 个月时二尖瓣反流严重程度降低至轻度或轻度至中度
大体时间：12个月
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12个月
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12 个月时左心室舒张末期容积 (LVEDV) 的变化超过基线
大体时间：12个月
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12个月
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12 个月时左心室收缩末期容积 (LVESV) 超过基线的变化
大体时间：12个月
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12个月
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12 个月时 6 分钟步行测试 (6MWT) 距离相对于基线的变化
大体时间：12个月
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12个月
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根据堪萨斯城心肌病问卷 (KCCQ) 衡量的生活质量 (QoL) 评分在基线后 12 个月的变化
大体时间：12个月
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12个月
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12 个月纽约心脏协会 (NYHA) 功能等级 I/II
大体时间：12个月
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12个月
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Piotr Ponikowski, MD, PhD、Military Hospital, Medical University, Wroclaw, Poland
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年4月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2015年1月1日
研究注册日期
首次提交
2013年1月17日
首先提交符合 QC 标准的
2013年1月17日
首次发布 (估计)
2013年1月21日
研究记录更新
最后更新发布 (实际的)
2018年11月7日
上次提交的符合 QC 标准的更新
2018年11月5日
最后验证
2018年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.