北京OmecamtivMecarbil缓释片III期临床试验-COMET-HF

登记号	CTR20260596	试验状态	进行中
申请人联系人	何艳	首次公示信息日期	2026-02-13
申请人名称	Cytokinetics, Incorporated/ 百时益医药研发（北京）有限公司/ Patheon, Inc./ Cytokinetics，Incorporated

登记号	CTR20260596
相关登记号	暂无
药物名称	Omecamtiv Mecarbil缓释片
药物类型	化学药物
临床申请受理号	企业选择不公示
适应症	症状性心脏衰竭伴射血分数降低(HFrEF)
试验专业题目	一项在症状性心脏衰竭伴射血分数降低患者中评估 OMECAMTIV MECARBIL 的有效性和安全性的多中心、双盲、随机、安慰剂对照试验
试验通俗题目	COMET-HF
试验方案编号	CY 1033	方案最新版本号	修正案 3
版本日期:	2024-12-23	方案是否为联合用药	否

申请人名称	[["Cytokinetics, Incorporated"],["百时益医药研发（北京）有限公司"],["Patheon, Inc."],["Cytokinetics，Incorporated"]]
联系人姓名	何艳	联系人座机	021-33072288	联系人手机号	18013233103
联系人Email	yan.he@thermofisher.com	联系人邮政地址	上海市-上海市-上海市黄浦区天津路155号恒基名人商业大厦1101室	联系人邮编	200001

主要目的：评价根据当地标准治疗，在指南指导的医学治疗背景下，Omecamtiv Mecarbil 与安慰剂相比在症状性 HFrEF 伴重度射血分数降低患者中对 HF 结局风险的有效性

试验分类	有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	双盲	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 85岁(最大年龄)
性别	男+女
健康受试者	无
入选标准	[["签署知情同意时年龄介于 ≥18 岁至 ≤85 岁"],["有慢性 HFrEF 病史，定义为在筛选前至少 3 个月需要 HF 治疗"],["正在接受口服袢利尿剂"],["筛选 ECG 上无 AFF 的患者：not筛选前 6 个月内 LVEF ＜30%notN 末端脑利钠肽激素原 (NT-proBNP) 升高 ≥1000 pg/mL（BNP ≥300 pg/mL）"],["筛选 ECG 上有 AFF 的患者：not筛选前 6 个月内 LVEF ＜25%notN 末端脑利钠肽激素原 (NT-proBNP) 升高 ≥3000 pg/mL（BNP ≥900 pg/mL）not目前没有服用地高辛"],["目前因主要原因 HF 住院治疗，或在筛选前 6 个月内发生 HF 事件"],["在筛选前接受了至少 30 天的区域性 HF 标准治疗"],["收缩压 ≤130 mmHg 且舒张压 ≤90 mmHg"]]
排除标准	[["筛选 ECG 上有 AFF，而且目前正在服用地高辛"],["筛选前 3 个月内患有急性冠脉综合征、行心脏手术、行瓣膜手术、进行任何冠状血管重建和/或接受心脏再同步治疗"],["入住长期护理机构或临终关怀机构"],["根据临床判断，因非心血管原因预计生存期 ＜12 个月"],["筛选前 ≤3 天正在接受正性肌力药静脉给药或血管加压药静脉给药"],["筛选前 ≤7 天内正在接受机械血流动力学支持或机械通气"],["筛选前 ≤12 小时正在接受利尿剂静脉给药、血管扩张剂静脉给药或补充氧疗"],["筛选时估计肾小球滤过率 (eGFR) ＜20 mL/min/1.73m2 或正在接受透析"],["既往接受过实体器官移植"],["正在另一项试验用器械或药物研究中接受治疗，或筛选时结束此类试验性治疗后不足 30 天"],["既往接受过 Omecamtiv Mecarbil"],["在研究期间怀孕或计划怀孕，或计划在 IP 治疗期间或 IP 治疗结束后 5 天内哺乳"]]

试验药

[["中文通用名:OmecamtivMecarbil 英文通用名:OmecamtivMecarbil 商品名称:NA","剂型:口服片剂 规格:25mg 用法用量:随机分配至omecamtivmecarbil组的参与者将基于其血浆omecamtivmecarbil浓度水平，以25，37.5或50mg每日两次给药，直至850例参与者发生HF事件或CV死亡，以先发生者为准。 用药时程:每日两次，直至850例参与者发生HF事件或CV死亡，以先发生者为准。"],["中文通用名:OmecamtivMecarbil 英文通用名:OmecamtivMecarbil 商品名称:NA","剂型:口服片剂 规格:37.5mg 用法用量:随机分配至omecamtivmecarbil组的参与者将基于其血浆omecamtivmecarbil浓度水平，以25，37.5或50mg每日两次给药，直至850例参与者发生HF事件或CV死亡，以先发生者为准。 用药时程:每日两次，直至850例参与者发生HF事件或CV死亡，以先发生者为准。"],["中文通用名:OmecamtivMecarbil 英文通用名:OmecamtivMecarbil 商品名称:NA","剂型:口服片剂 规格:50mg 用法用量:随机分配至omecamtivmecarbil组的参与者将基于其血浆omecamtivmecarbil浓度水平，以25，37.5或50mg每日两次给药，直至850例参与者发生HF事件或CV死亡，以先发生者为准。 用药时程:每日两次，直至850例参与者发生HF事件或CV死亡，以先发生者为准。"]] 序号 名称 用法

对照药

[["中文通用名:安慰剂 英文通用名:Placebo 商品名称:NA","剂型:口服片剂 规格:匹配的安慰剂 用法用量:随机分配至安慰剂组的参与者将每日两次服用安慰剂，直至850例参与者发生HF事件或CV死亡，以先发生者为准。 用药时程:每日两次，直至850例参与者发生HF事件或CV死亡，以先发生者为准。"],["中文通用名:安慰剂 英文通用名:Placebo 商品名称:NA","剂型:口服片剂 规格:匹配的安慰剂 用法用量:随机分配至安慰剂组的参与者将每日两次服用安慰剂，直至850例参与者发生HF事件或CV死亡，以先发生者为准。 用药时程:每日两次，直至850例参与者发生HF事件或CV死亡，以先发生者为准。"],["中文通用名:安慰剂 英文通用名:Placebo 商品名称:NA","剂型:口服片剂 规格:匹配的安慰剂 用法用量:随机分配至安慰剂组的参与者将每日两次服用安慰剂，直至850例参与者发生HF事件或CV死亡，以先发生者为准。 用药时程:每日两次，直至850例参与者发生HF事件或CV死亡，以先发生者为准。"]] 序号 名称 用法

主要终点指标及评价时间

[["至首次发生CV 死亡、HF 事件、LVAD 植入或心脏移植、卒中的时间","从随机分组到首次发生CV死亡事件或HF事件（以先发生者为准），评估至最后一名患者退出研究，估计持续约3年","有效性指标"]] 序号 指标 评价时间 终点指标选择

次要终点指标及评价时间

[["至首次发生CV死亡或HF 事件的时间","从随机分组到首次发生CV死亡事件或HF事件（以先发生者为准），评估至最后一名患者退出研究，估计持续约3年","有效性指标"],["至首次 HF 住院治疗的时间","从随机分组到首次发生CV死亡事件或HF事件（以先发生者为准），评估至最后一名患者退出研究，估计持续约3年","有效性指标"],["在重度 HF 患者亚组中至首次发生CV 死亡、HF 事件、LVAD 植入/心脏移植，或卒中的时间","从随机分组到首次发生CV死亡事件或HF事件（以先发生者为准），评估至最后一名患者退出研究，估计持续约3年","有效性指标"],["至首次发生CV 死亡、LVAD 植入/心脏移植或卒中的时间","从随机分组到首次发生CV死亡事件或HF事件（以先发生者为准），评估至最后一名患者退出研究，估计持续约3年","有效性指标"],["至 CV 死亡的时间","从随机分组到首次发生CV死亡事件或HF事件（以先发生者为准），评估至最后一名患者退出研究，估计持续约3年","有效性指标"],["至首次发生卒中事件的时间","从随机分组到首次发生CV死亡事件或HF事件（以先发生者为准），评估至最后一名患者退出研究，估计持续约3年","有效性指标"],["至全因死亡的时间","从随机分组到首次发生CV死亡事件或HF事件（以先发生者为准），评估至最后一名患者退出研究，估计持续约3年","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	张宇辉	学位	医学博士	职称	主任医师
	电话	15901314243	Email	yuhuizhang@163.com	邮政地址	北京市-北京市-西城区北礼士路167号
	邮编	100037	单位名称	中国医学科学院阜外医院

[["中国医学科学院阜外医院","张宇辉","中国","北京市","北京市"],["广东省人民医院","黎励文","中国","广东省","广州市"],["徐州医科大学附属医院","朱红","中国","江苏省","徐州市"],["南华大学附属第一医院","唐惠芳","中国","湖南省","衡阳市"],["广州医科大学附属番禺中心医院","陈国钦","中国","广东省","广州市"],["浙江省台州医院","米亚非","中国","浙江省","台州市"],["河南科技大学第一附属医院","李志娟","中国","河南省","洛阳市"],["海南省人民医院","廖旺","中国","海南省","海口市"],["山东大学齐鲁医院","卜培莉","中国","山东省","济南市"],["辽宁省人民医院","侯爱洁","中国","辽宁省","沈阳市"],["哈尔滨医科大学附属第一医院","富路","中国","黑龙江省","哈尔滨市"],["山西省运城市中心医院","屈艳玲","中国","山西省","运城市"],["陕西省人民医院","姜馨","中国","陕西省","西安市"],["北京大学第三医院","陈宝霞、李丹","中国","北京市","北京市"],["菏泽市立医院","牛文堂","中国","山东省","菏泽市"],["重庆大学附属三峡医院","张建明","中国","重庆市","重庆市"],["丽水市中心医院","吕玲春","中国","浙江省","丽水市"],["天津医科大学总医院","杨清","中国","天津市","天津市"],["湘潭市中心医院","吴名星","中国","湖南省","湘潭市"],["山西省心血管病医院","张丽晖","中国","山西省","太原市"],["泰达国际心血管病医院","宋昱","中国","天津市","天津市"],["长沙市第三医院","张育民","中国","湖南省","长沙市"],["苏北人民医院","顾翔","中国","江苏省","扬州市"],["郑州大学第一附属医院","赵肸","中国","河南省","郑州市"],["广西医科大学第一附属医院","黄凯","中国","广西壮族自治区","南宁市"],["重庆市急救医疗中心（重庆市第四人民医院）","张冬颖","中国","重庆市","重庆市"],["兰州大学第二医院","张小卫","中国","甘肃省","兰州市"],["湖南省人民医院（湖南师范大学附属第一医院）","颜素岚","中国","湖南省","长沙市"],["香港大学深圳医院","刘铭雅","中国","广东省","深圳市"],["吉林大学中日联谊医院","贺玉泉","中国","吉林省","长春市"],["中山大学孙逸仙纪念医院","张玉玲","中国","广东省","广州市"],["赤峰学院附属医院","祁宏","中国","内蒙古自治区","赤峰市"],["济宁医学院附属医院","尉希清","中国","山东省","济宁市"],["吉林大学第一医院","郑杨","中国","吉林省","长春市"],["CHU de Toulouse- Hpital de Rangueil","Galinier, Michel","France","Haute-Garonne","Toulouse"],["CHU de Montpellier - Hpital Arnaud de Villeneuve","Roubille, Francois","France","Hérault","Montpellier"],["Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer Hopital Sainte Musse","Tartiere, Jean-Michel","France","Var","Toulon"],["AP-HP - Hpital Bichat - Claude Bernard","Jondeau, Guillaume","France","Paris","Paris"],["Hpital privé du Confluent","Gueffet, Jean-Pierre","France","Nantes","Nantes"],["AP-HP - Hopital Européen Georges Pompidou","Hagege, Albert","France","Paris","Paris"],["CHU de Grenoble Alpes - Hpital Michallon","Salvat, Muriel","France","Isère","La Tronche"],["AP-HP - Hopital Lariboisiere","Logeart, Damien","France","Paris","Paris"],["Polyclinique Vauban","Caudmont, Sebastien","France","Valenciennes","Valenciennes"],["CHU de Rennes - Hpital Pontchaillou","Donal, Erwan","France","Ille-et-Vilaine","Rennes"],["Universit tsmedizin G ttingen","Von Haehling, Stephan","Germany","Niedersachsen","Gttingen"],["Universittsklinikum Jena","Westphal, Julian","Germany","Thüringen","Jena"],["Marienhaus Klinikum Mainz","Genth-Zotz, Sabine","Germany","Mainz","Mainz"],["Universittsklinikum Bonn","oztürk, Can","Germany","Nordrhein-Westfalen","Bonn"],["Universittsklinikum Frankfurt","Papathanasiou, Maria","Germany","Hesse","Frankfurt am Main"],["Praxis fur Kardiologie Dr Jens Taggeselle","Taggeselle, Jens","Germany","Markleeberg","Markleeberg"],["Kerckhoff-Klinik GmbH","Rieth, Andreas","Germany","Hesse","Bad Nauheim"],["Helios Klinikum Erfurt","Lauten, Alexander","Germany","Erfurt","Erfurt"],["Asklepios Klinik Langen","Mittag, Marcus","Germany","Langen","Langen"],["LMU Klinikum der Universitt München - Campus Grohadern","Kb, Stefan","Germany","Bavaria","München"],["Universittsklinikum Hamburg Eppendorf","Magnussen, Christina","Germany","Hamburg","Hamburg"],["Universittsklinikum Heidelberg","Meder, Benjamin","Germany","Baden-Württemberg","Heidelberg"],["Universittsklinikum Würzburg","Strk, Stefan","Germany","Bavaria","Würzburg"],["Universitatsklinikum des Saarlandes","Kindermann, Ingrid","Germany","Saarland","Homburg"],["General Hospital of Athens ''G. Gennimatas''","Karavidas, Apostolos","Greece","Anatoliki Attiki","Athens"],["University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA","Filippatos, Gerasimos","Greece","Anatoliki Attiki","Chaidari"],["Papageorgiou General Hospital of Thessaloniki","Styliadis, Ioannis","Greece","Thessaloniki","N. Efkapria-Pavlos Melas"],["University General Hospital of Alexandroupolis","Tziakas, Dimitrios","Greece","Evros","Alexandroupoli"],["General Hospital of Nea Ionia ''Konstantopouleio-Patision''","Patsilinakos, Sotirios","Greece","Anatoliki Attiki","Nea Ionia"],["AHEPA University General Hospital of Thessaloniki","Ziakas, Antonios","Greece","Thessaloniki","Thessaloniki"],["University General Hospital of Larissa","Giamouzis, Gregory","Greece","Larisa","Larissa"],["General Hospital of Chalkida","Toli, Konstantina","Greece","Chalkida","Chalkida"],["General Hospital ''Asklepieio Voulas''","Poulimenos, Leonidas","Greece","Anatoliki Attiki","Voula"],["General Hospital of Athens ''Hippokratio''","Chrysochoou, Christina","Greece","Anatoliki Attiki","Athens"],["ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia","Inciardi, Riccardo","Italy","Brescia","Brescia"],["Centro Cardiologico Monzino","Agostoni, Piergiuseppe","Italy","Milan","Milano"],["Gruppo MultiMedica SpA - IRCCS Multimedica","Bandera, Francesco","Italy","Sesto San Giovanni","Sesto San Giovanni"],["Ospedale San Raffaele S.r.l. - PPDS","Bassanelli, Giorgio","Italy","Lombardia","Milano"],["ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII","Senni, Michele","Italy","Lombardia","Bergamo"],["Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia","Carluccio, Erberto","Italy","Umbria","Perugia"],["Ospedale di Arzignano","Bilato, Claudio","Italy","Veneto","Arzignano"],["AUSL della Romagna - Ospedale Infermi di Rimini","Carigi, Samuela","Italy","Emilia-Romagna","Rimini"],["Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna","Fucili, Alessandro","Italy","Emilia-Romagna","Cona"],["IRCCS San Raffaele","Volterrani, Maurizio","Italy","Lazio","Roma"],["balsamMEDICA Sp. z o.o.","Januszkiewicz, Lukasz","Poland","Mazowieckie","Warszawa"],["SPZOZ Centralny Szpital Kliniczny UM w Lodzi - Pomorska 251","Drozdz, Jaroslaw","Poland","Lódzkie","Lodz"],["Centralny Szpital Kliniczny UCK WUM","Ozieranski, Krzysztof","Poland","Warszawa","Warszawa"],["Krakowski Szpital Specjalistyczny im. w. Jana Pawa II","Konieczynska, Malgorzata","Poland","Malopolskie","Kraków"],["Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Curie-Sklodowskiej 24a","Tycinska, Agnieszka","Poland","Podlaskie","Bialystok"],["Wojewodzki Szpital Zespolony Im L Rydygiera","Skonieczny, Grzegorz","Poland","Torun","Torun"],["Szpital Swietej Anny w Miechowie","Kafara, Mariusz","Poland","Malopolskie","Miechow"],["Poradnia Aka-Med Centrum sp. z o.o.","Spyra, Janusz","Poland","Ruda Slaska","Ruda Slaska"],["Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Lodzi","Lelonek, Magorzata","Poland","Lódzkie","Lodz"],["Tomasz Blicharski Lubelskie Centrum Diagnostyczne.","Blicharski, Tomasz","Poland","Swidnik","Swidnik"],["Uniwersytecki Szpital Kliniczny w Poznaniu- Dluga 1/2","Straburzynska-Migaj, Ewa","Poland","Wielkopolskie","Poznan"],["Uniwersytecki Szpital Kliniczny w Opolu","Gierlotka, Marek","Poland","Opolskie","Opole"],["Hospital Universitario A Corua","Crespo-Leiro, Maria Generosa","Spain","A Corua","a Corua"],["Hospital Universitario Puerta de Hierro - Majadahonda","García Pavia, Pablo","Spain","Madrid","Majadahonda"],["Hospital Clinico Universitario de Santiago","Gonzalez Juanatey, Jose Ramon","Spain","A Corua","Santiago de Compostela"],["CHUVI – H.U. Alvaro Cunqueiro","Jimenez Diaz, Victor Alfonso","Spain","Pontevedra","Vigo"],["Hospital de La Santa Creu i Sant Pau","Mirabet Perez, Sonia","Spain","Barcelona","Barcelona"],["Hospital Universitario Virgen de La Arrixaca","Pascual Figal, Domingo Andres","Spain","Murcia","El Palmar"],["Hospital Universitario Virgen del Rocio - PPDS","Rangel-Sousa, Diego","Spain","Sevilla","Sevilla"],["Hospital Universitario La Paz - PPDS","Moreno Gomez, Jose Raul","Spain","Madrid","Madrid"],["Hospital Clinico Universitario de Valencia","Nuez Villota, Julio","Spain","Valencia","Valencia"],["Hospital Universitari i Politecnic La Fe de Valencia","Almenar Bonet, Luis","Spain","Valencia","Valencia"],["Hospital San Juan de la Cruz","Bonilla Palomas, Juan Luis","Spain","úbeda","úbeda"],["Hospital Universitario 12 de Octubre","Garcia-Cosio Carmena, Maria Dolores","Spain","Madrid","Madrid"],["Hospital Universitari de Tarragona Joan XXIII","Ferreiro Gutierrez, Jose Luis","Spain","Tarragona","Tarragona"],["Hospital Universitario de Bellvitge","González Costello, Jose","Spain","Barcelona","L'hospitalet de Llobregat"],["Hospital Universitario Vall d'Hebron - PPDS","Mendez Fernandez, Ana Belen","Spain","Barcelona","Barcelona"],["Hospital Universitario De Salamanca","Rincón Diaz, Luis Miguel","Spain","Salamanca","Salamanca"],["Hospital Universitario Lucus Augusti","Gonzalez Juanatey, Carlos","Spain","Lugo","Lugo"],["Glasgow Royal Infirmary - PPDS","Docherty, Kieran","United Kingdom","Glasgow","Glasgow"],["Ulster Hospital","Donnelly, Patrick","United Kingdom","Belfast","Belfast"],["Russells Hall Hospital","Barr, Craig","United Kingdom","Dudley","Dudley"],["Basingstoke and North Hampshire Hospital","Glover, Jason","United Kingdom","Basingstoke","Basingstoke"],["Great Western Hospital","Chandrasekaran, Badrinathan","United Kingdom","Wiltshire","Swindon"],["Castle Hill Hospital - PPDS","Clark, Andrew","United Kingdom","Northamptonshire","Cottingham"],["Queen Elizabeth University Hospital - PPDS","Campbell, Ross","United Kingdom","Lancashire","Glasgow"],["Harefield Hospital","Dar, Owais","United Kingdom","Harfield","Harfield"],["Southampton General Hospital","Cowburn, Peter","United Kingdom","Hampshire","Southampton"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["中国医学科学院阜外医院伦理委员会","同意","2026-01-19"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；