北京PF-07328948片II期临床试验-一项在心力衰竭成人患者中评估 PF-07328948 的疗效和安全性的 II 期研究 (BRANCH-HF)

登记号	CTR20260259	试验状态	进行中
申请人联系人	张浪	首次公示信息日期	2026-01-26
申请人名称	Pfizer Inc./ 辉瑞（北京）研究开发有限公司

登记号	CTR20260259
相关登记号	暂无
药物名称	PF-07328948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	用于成人慢性心力衰竭的治疗
试验专业题目	一项在心力衰竭成人患者中评估口服支链酮酸脱氢酶激酶抑制剂 PF-07328948 的疗效和安全性的 II 期、随机、双盲、安慰剂对照研究 (BRANCH-HF)
试验通俗题目	一项在心力衰竭成人患者中评估 PF-07328948 的疗效和安全性的 II 期研究 (BRANCH-HF)
试验方案编号	C4921003	方案最新版本号	最终方案
版本日期:	2025-03-05	方案是否为联合用药	否

申请人名称	[["Pfizer Inc."],["辉瑞（北京）研究开发有限公司"]]
联系人姓名	张浪	联系人座机	021-28935963	联系人手机号	13820682486
联系人Email	lang.zhang@pfizer.com	联系人邮政地址	上海市-上海市-浦东新区中科路1699号上海科技投资大厦6楼辉瑞	联系人邮编	201203

本研究旨在了解研究药物（PF-07328948）在治疗心力衰竭（HF）方面的安全性和疗效。

试验分类	安全性和有效性	试验分期	II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 无上限 (最大年龄)
性别	男+女
健康受试者	无
入选标准	[["年龄 ≥ 18 岁"],["临床确诊为心衰至少 3 个月"],["纽约心脏协会心功能分级为 II-IV 级"],["左心室射血分数大于 40%"],["身体质量指数≥ 27.0 kg/m2"],["堪萨斯城心肌病问卷 23 总症状评分 < 85"],["六分钟步行距离超过 75 米"]]
排除标准	[["1 型糖尿病，肝硬化，或任何可能影响药物吸收的状况"],["计划在试验期间进行任何研究者认为影响行走能力的重大手术"],["心脏移植史、目前正在等待心脏移植、当前计划使用静脉血管扩张剂和/或正性肌力药"],["既往 SGLT2i 不耐受/已知超敏反应史或存在 SGLT2i 禁忌症"]]

试验药	[["中文通用名:PF-07328948 英文通用名:PF-07328948 商品名称:NA","剂型:片剂 规格:Amg 用法用量:低剂量组：每日一次,口服；高剂量组：每日一次,口服 用药时程:36周"],["中文通用名:PF-07328948 英文通用名:PF-07328948 商品名称:NA","剂型:片剂 规格:Bmg 用法用量:中剂量组：每日一次,口服,；高剂量组：每日一次,口服 用药时程:36周"]] 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:片剂 规格:0mg 用法用量:每日一次,口服,与相应试验组相匹配的剂量 用药时程:36周"]] 序号 名称 用法

主要终点指标及评价时间	[["截至第 36 周的裁定心血管死亡和心衰恶化事件","截至36周","有效性指标"],["6 分钟步行距离较基线的变化","基线，36周","有效性指标"],["KCCQ-23症状总评分较基线的变化","基线，36周","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	[["TEAE 和 TESAE 的发生率","基线至40周","安全性指标"],["KCCQ-23 症状总评分、临床总评分和身体限制较基线的变化","基线，36周","有效性指标"],["6 分钟步行距离较基线的变化","基线，36周","有效性指标"],["峰值耗氧量（pVO2）较基线的变化","基线，36周","有效性指标"],["NT-proBNP浓度较基线的变化","基线，36周","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	霍勇	学位	医学硕士	职称	主任医师
	电话	13901333060	Email	huoyong@263.net.cn	邮政地址	北京市-北京市-西城区西什库大街8号
	邮编	100034	单位名称	北京大学第一医院

[["北京大学第一医院","霍勇","中国","北京市","北京市"],["北京大学第一医院","马为","中国","北京市","北京市"],["河北医科大学第一医院","郑明奇","中国","河北省","石家庄市"],["济南市中心医院","苏国海","中国","山东省","济南市"],["陕西省人民医院","王军奎","中国","陕西省","西安市"],["天津市人民医院","姚朱华","中国","天津市","天津市"],["中南大学湘雅二医院","彭道泉","中国","湖南省","长沙市"],["吉林大学中日联谊医院","杨萍","中国","吉林省","长春市"],["南华大学附属第一医院","唐惠芳","中国","湖南省","衡阳市"],["海南省人民医院","乔平","中国","海南省","海口市"],["广东省人民医院","黎励文","中国","广东省","广州市"],["兰州大学第二医院","余静","中国","甘肃省","兰州市"],["中山大学附属第一医院","董吁钢","中国","广东省","广州市"],["上海市同济医院","赵翠梅","中国","上海市","上海市"],["复旦大学附属中山医院","周京敏","中国","上海市","上海市"],["HOSPITAL UNIVERSITARIO PUERTA DE HIERRO HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA","Cobo Marcos, Marta","西班牙","MADRID","Majadahonda"],["HOSPITAL CLINICO DE VALENCIA","Nunez Villota, Julio","西班牙","VALENCIANA, COMUNITAT","Valencia"],["Hospital Universitario La Paz","Moreno Gomez, Raul","西班牙","MADRID, COMUNIDAD DE","Madrid"],["CMed Rehabilitacios es Diagnosztikai Kozpont","Noori, Ebrahim","匈牙利","FEJER","Szekesfehervar"],["Reid Physician Associates","McGinty, John Edward","美国","INDIANA","Richmond"],["Hospital Universitari i Politecnic La Fe","Lopez Vilella, Raquel","西班牙","VALENCIA","Valencia"],["North Dallas Research Associates","Khan, Muhammad Akram","美国","TEXAS","McKinney"],["Ascension Saint Agnes Heart Care","Jesse Doran","美国","MARYLAND","Baltimore"],["Parc de Salut Mar - Hospital del Mar","VALDIVIELSO MORE, SANDRA","西班牙","CATALUNYA [CATALUNA]","Barcelona"],["National Heart Institute","Lepor, Norman ELLIOTT","美国","CALIFORNIA","Beverly Hills"],["Diex Recherche Trois-Rivieres","Sia, Ying Tung","加拿大","QUEBEC","Trois-Rivieres"],["CHU de Quebec - Université Laval - Hotel Dieu de Quebec","Joncas, Sebastien Xavier","加拿大","QUEBEC","Quebec"],["Centre intégré de santé et de services sociaux de Lanaudière - Hopital Pierre-Le Gardeur.","Gosselin, Gilbert","加拿大","QUEBEC","Terrebonne"],["Medical Center Hera - Kyustendil EOOD","Kolomanov, Borislav","保加利亚","KYUSTENDIL","Kyustendil"],["Diagnostic Consultative Center Aleksandrovska","Runev, Nikolay","保加利亚","NA","Sofia"],["MHAT - Heart and Brain","Simova, Iana","保加利亚","PLEVEN","Pleven"],["Hospital General Universitario de Valencia","Pérez Silvestre, José","西班牙","VALENCIANA, COMUNITAT","Valencia"],["Semmelweis Egyetem","Merkely, Bela","匈牙利","BUDAPEST","Budapest"],["Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD","Stoyanov, Miroslav Velev","保加利亚","GABROVO","Gabrovo"],["Sekino Hospital","Sekino, Hisakuni","日本","TOKYO","Toshima-ku"],["National Hospital Organization Yokohama Medical Center","Mori, Fumiaki","日本","KANAGAWA","Yokohama"],["Teine Keijinkai Hospital","Yuda, Satoshi","日本","HOKKAIDO","Sapporo"],["Diagnostic Consultative Center Ascendent","Yanev, Todor I","保加利亚","SOFIA","Sofia"],["University Multiprofile Hospital for Active Treatment Sveti Georgi EAD","Goranov, Georgi","保加利亚","PLOVDIV","Plovdiv"],["NZOZ Centrum Medyczne KERmed","Lugowski, Tomasz","波兰","KUJAWSKO-POMORSKIE","Bydgoszcz"],["Community Care Building Winchester District Memorial Hospital","Sharma, Kamal","加拿大","ONTARIO","Winchester"],["Kardio Brynow","Wojakowski, Wojciech","波兰","SLASKIE","Katowice"],["Orange County Research Center","JOEL NEUTEL","美国","CALIFORNIA","LAKE FOREST"],["Uniwersytecki Szpital Kliniczny w Poznaniu","Straburzynska Migaj, Ewa","波兰","WIELKOPOLSKIE","Poznan"],["Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L","Perea, Francisco Martin","阿根廷","TUCUMAN","San Miguel de Tucumán"],["National Hospital Organization Tokyo Medical Center","Inagawa, Kohei","日本","TOKYO","Meguro-Ku"],["DIM Clinica Privada","Montana, Oscar Romano","阿根廷","BUENOS AIRES","Ramos Mejia"],["CHUS - Hospital Clinico Universitario","Gomez-Otero, Maria Ines","西班牙","A CORUNA [LA CORUNA]","Santiago de Compostela"],["AGEL Stredomoravska nemocnicni, a.s., Nemocnice AGEL Prerov","Marek, Dan","捷克共和国","PLOVDIV","Prerov"],["Multiprofile Hospital for Active Treatment Puls AD","Dzhumean, Yordan Huseinov","保加利亚","BLAGOEVGRAD","Blagoevgrad"],["MHAT Hadzhi Dimitar","Bletsova, Kostadinka","保加利亚","SLIVEN","Sliven"],["Corporacion Medica San Martin","Ahuad Guerrero, Rodolfo Andres","阿根廷","CIUDAD AUTONOMA DE BUENOS AIRES","San Martin - Buenos Aires"],["Sanatorio Britanico","Piskorz, Daniel","阿根廷","SANTA FE","Rosario"],["Centre Hospitalier intercommunal de Toulon La Seyne sur Mer","Tartiere, Jean-Michel","法国","VAR","Toulon"],["Hospital Universitari de Bellvitge","Enjuanes Grau, Cristina","西班牙","BARCELONA [BARCELONA]","BARCELONA [BARCELONA]tL Hospitalet De Llobregat"],["Velocity Clinical Research, Lincoln, Pioneer Heart Institute","Martin, Steven Leslie","美国","NEBRASKA","Lincoln"],["National Hospital Organization Saitama Hospital","matsumura, keisuke","日本","SAITAMA","Wako"],["Sagamihara Kyodo Hospital","doi, shoko","日本","KANAGAWA","Sagamihara"],["Tokyo Metropolitan Toshima Hospital","Nakajima, Jun","日本","TOKYO","Itabashi-ku"],["Hopital Nord Guillaume-et-René-Laennec / CHU de Nantes","STEVANT, David","法国","LOIRE-ATLANTIQUE","Saint-Herblain"],["Hospital de la Santa Creu i Sant Pau","de Antonio, Marta","西班牙","CATALUNYA [CATALUNA]","Barcelona"],["Seikeikai New Tokyo Heart Clinic","Yuki, Haruhito","日本","CHIBA","Matsudo"],["Аcibadem City Clinic University MHAT EOOD - Third Clinical Base","Petrov, Ivo","保加利亚","SOFIA","Sofia"],["University Multiprofile Hospital for Active Treatment Sveta Ekaterina EAD","Atzev, Borislav Borislav","保加利亚","SOFIA (STOLITSA)","Sofia"],["Amavita Research Services","Martinez Clark, Pedro","美国","FLORIDA","North Miami Beach"],["Da Vinci Magánklinika","Vorobcsuk, Andras","匈牙利","BARANYA","Pécs"],["Hopital Arnaud de Villeneuve - CHU Montpellier","ROUBILLE, Francois","法国","HERAULT","MONTPELLIER CEDEX 5"],["Infinite Clinical Research","Escalante, Jose Enrique","美国","FLORIDA","Miami"],["Clinique de Médecins Spécialistes Diex Recherche Sherbrooke Est","Roux, Jean-francois","加拿大","QUEBEC","Sherbrooke"],["Northwest Houston Heart Center","Aslam, Shamaila","美国","TEXAS","Tomball"],["Wycombe General Hospital","Clifford, Piers","英国","ENGLAND","high Wycombe"],["National Hospital Organization Sendai Medical Center","Onoue, Noriko","日本","MIYAGI","Sendai"],["Hospital Privado Universitario de Córdoba","Amuchastegui, Marcos","阿根廷","CóRDOBA","Córdoba"],["Chicago Medical Research","Khadra, Suhail","美国","ILLINOIS","Hazel Crest"],["South Eastern Health and Social Care Trust","Donnelly, Patrick","英国","LISBURN AND CASTLEREAGH","Belfast"],["National Hospital Organization Iwakuni Clinical Center","Katayama, Yusuke","日本","YAMAGUCHI","Iwakuni"],["St. George`s Hospital","Peterzan, Mark Andrew","英国","ENGLAND","London"],["Multiprofile Hospital for Active Treatment Knyaginya Klementina - Sofia EAD","Dimov, Bojidar Ivanov","保加利亚","SOFIA (STOLITSA)","Sofia"],["CHU GRENOBLE ALPES","Salvat, Muriel","法国","ISERE","Genoble"],["Yokohama Municipal Citizen's Hospital","Shinmura, Daisuke","日本","KANAGAWA","Yokohama"],["NZOZ Sopockie Centrum Badan Kardiologicznych Pro Cordis Pawel Miekus","Miekus, Pawel","波兰","POMORSKIE","Sopot"],["EDUMED s.r.o.","Vesely, Jiri","捷克共和国","NA","Jaromer"],["NexGen Research","Ezema, Nonso","美国","OHIO","Lima"],["Kardiologicka ambulance Brno s.r.o.","Parenica, Jiri","捷克共和国","NA","Brno - Kralovo Pole"],["National Hospital Organization Mie Chuo Medical Center","Shintani, Takuya","日本","MIE","Tsu"],["NewHeart Watanabe Institute","Kon, Junichi","日本","TOKYO","Suginami"],["Hospital Universitari Vall d`Hebron","Olivella San Emeterio, Aleix","西班牙","BARCELONA [BARCELONA]","Barcelona"],["Fakultni nemocnice Hradec Kralove","Pelouch, Radek","捷克共和国","KRALOVEHRADECKY KRAJ","Hradec Kralove"],["VASOMED Clinic s.r.o.","Maderic, David","捷克共和国","NA","Ostrava"],["ACV Clinic Health Sciences North Research Institute","Costa-Vitali, Atilio","加拿大","ONTARIO","Sudbury"],["QEII Health Sciences Centre – Victoria General Site","Anderson, Kim","加拿大","NOVA SCOTIA","Halifax"],["Kasugai Municipal Hospital","Fujikawa, Yusuke","日本","AICHI","Kasugai"],["Kishiwada Tokushukai Hospital","Kuroyanagi, Satoshi","日本","OSAKA","Kishiwada"],["Nagoya Tokushukai General Hospital","Ishiguro, Nobuo","日本","AICHI","Kasugai"],["Koga General Hospital","Sakamoto, Yukinori","日本","IBARAKI","Koga"],["CardioQuest Research Centre","Al-Saadon, Khalid","加拿大","ONTARIO","Sarnia"],["EFERTUS healthcare s.r.o.","Matejovska, Hana","捷克共和国","NA","Brno-Zidenice"],["Instituto Médico DAMIC","MARTINEZ, DIEGO FELIPE","阿根廷","CORDOBA","CORDOBA"],["SP ZOZ w Pulawach","Gniot, Jacek","波兰","LUBELSKIE","Pulawy"],["FWD Clinical Research","Panakos, Andrew","美国","FLORIDA","Boca Raton"],["Nagasaki Harbor Medical Center","Nunohiro, Tatsuya","日本","NAGASAKI","Nagasaki"],["Hospital Universitario Ramón y Cajal","LLACER IBORRA, PAU","西班牙","MADRID, COMUNIDAD DE","Madrid"],["Incor - Instituto do Coracao","Bocchi, Edimar Alcides","巴西","SAO PAULO","Sao Paulo"],["Showa General Hospital","Tanaka, Takahiro","日本","TOKYO","Kodaira-shi"],["Sdruzene Zdravotnicke Zarizeni Krnov","Capek, Bronislav","捷克共和国","MORAVSKOSLEZSKY KRAJ","Krnov"],["Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu","Skonieczny, Grzegorz","波兰","NA","Torun"],["Toho University Sakura Medical Center","Shimizu, Kazuhiro","日本","CHIBA","Sakura"],["Ezustfeny Klinika Kft","Frész, Tamás","匈牙利","BUDAPEST","Budapest"],["Ninewells Hospital and Medical School","Choy, Anna Maria","英国","SCOTLAND","Dundee"],["Northern General Hospital","Al-Mohammad, Abdallah","英国","ENGLAND","Sheffield"],["St Richard`s Hospital","Wong, Yuk-ki","英国","ENGLAND","Chichester"],["CEPIC - Centro Paulista de Investigacao Clinica","DE ABREU SILVA, ERLON O.","巴西","SAO PAULO","SAO PAULO"],["Diagnostic Consultative Center – 1 Lom EOOD","Simeonov, Dilyan","保加利亚","MONTANA","Lom"],["NexGen Research","Reddy, Subhash K","美国","INDIANA","Fort Wayne"],["New Medical Center Kft.","Bernieh, Basl","匈牙利","NA","Sopron"],["Centro de Investigaciones Clinicas del Litoral","Hominal, Miguel","阿根廷","SANTA FE","Santa Fe"],["Richmond Clinical Trials","Lucas, Alexandra","加拿大","BRITISH COLUMBIA","Richmond"],["Headlands Horizons, LLC dba Headlands Research-Brownsville Valley Regional Medical Center","Christopher Romero","美国","TEXAS","Brownsville"],["Medical Center Hera EOOD","Pancheva, Ralitsa Dimitrova","保加利亚","SOFIA","Sofia"],["Miejski Szpital Zespolony w Olsztynie","Rynkiewicz, Andrzej","波兰","WARMINSKO-MAZURSKIE","Olsztyn"],["Centro Avancado De Pesquisa, Estudos E Diagnóstico (CAPED) - Centro Médico RibeiraoShopping","Schwartzmann, Pedro Vellosa","巴西","SAO PAULO","ribeirao preto"],["Cardresearch - Cardiologia Assistencial e Pesquisa","Reis, Gilmar","巴西","MINAS GERAIS","Belo Horizonte"],["IMV Pesquisa Cardiologica - Porto Alegre - Rua Orfanotrofio","Manenti, Euler Roberto Fernandes","巴西","RIO GRANDE DO SUL","Porto Alegre"],["Nucleo de Pesquisa Clínica do Rio Grande do Sul","Canani, Luis Henrique","巴西","RIO GRANDE DO SUL","Porto Alegre"],["Fundacao Faculdade Regional de Medicina de Sao José do Rio Preto","Maia, Lilia Nigro","巴西","SAO PAULO","Sao Jose do Rio Preto"],["UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu","Bazan, Silmeia Zanati","巴西","SAO PAULO","Botucatu"],["L2IP - Instituto de Pesquisas Clínicas","Vasconcellos, Eduardo Freire","巴西","DISTRITO FEDERAL","Brasília"],["CIUSSS- saguenay-Lac-Saint-Jean","Bonenfant, Francis","加拿大","QUEBEC","Chicoutimi"],["Corcare","Mukherjee, Ashok","加拿大","ONTARIO","Toronto"],["BKS Research Kft","Kalman, Krisztina","匈牙利","NA","Hatvan"],["Eszak-Pesti Centrumkorhaz-Honvedkorhaz","Lovasz, Orsolya","匈牙利","BUDAPEST","Budapest"],["Texas Health Heart & Vascular Specialist #18748 Texas Health Research & Education Institute - Fort Worth","Savla, Jainy Jayantilal","美国","TEXAS","Fort Worth"],["Jahn Ferenc Del-pesti Hospital","Lippai, Jozsef","匈牙利","BUDAPEST","Budapest"],["Instituto de Pesquisa clinica de Campinas","Saraiva, Jose Francisco Kerr","巴西","SAO PAULO","Campinas"],["NMH Clinical Research Unit Northwestern Memorial HealthCare - Arkes Pavilion Northwestern Memorial HealthCare - Feinberg Pavilion Northwestern Memorial HealthCare - Galter Pavilion Northwestern Memorial Hospital Investigational Drug Service (IDS) Northwestern University","Shah, Sanjiv","美国","IL","Chicago"],["Jacksonville Center for Clinical Research","Koren, Michael J.","美国","FLORIDA","Jacksonville"],["Flourish Research Acquisition, LLC dba Flourish Research – North Miami","Denis, Rimsky","美国","FLORIDA","Miami"],["Clinical Site Partners, LLC dba Flourish Research","Aggarwal, Monica","美国","FLORIDA","Winter Park"],["Norfolk and Norwich University Hospitals NHS Foundation Trust","Ryding, Alisdair","英国","NA","Cringleford"],["Comprehensive Cardiovascular Care FOMAT Medical Research","Harrison, Alexander","美国","CALIFORNIA","Santa Maria"],["Research and Cardiovascular Corp.","Vazquez-Tanus, Jose B.","波多黎各","PUERTO RICO","Ponce"],["Chesapeake Cardiac Care Flourish Research - Bowie","Collins, Sara","美国","MARYLAND","Bowie"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["北京大学第一医院生物医学研究伦理委员会","同意","2025-11-25"]]

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: 60 ； 国际: 620 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 22 ；
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：2025-06-19；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2025-09-15；
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；