苦辛方治疗扩张型心肌病相关心力衰竭的疗效与安全性：一项随机、双盲、安慰剂对照、多中心临床试验的研究方案
Efficacy and Safety of Kuoxin Formula in the Treatment of Dilated Cardiomyopathy-Related Heart Failure: Study Protocol of a Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial.
作者信息
Wu Qiong, An Shiying, Lee RueyJyh, Gao Dongwen, Zhou Yinyifan, Peng Longping, Hu Chunrui, Yao Lei, Zhou Chang, Zhou Li, Gao Junjie, Cao Min, Mao Meijiao, Li Guanghao, Deng Bing, Xu Yingjia, Wang Youhua
机构信息
Department of Cardiology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
Department of Ultrasound, Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
出版信息
Int J Gen Med. 2024 May 6;17:1909-1921. doi: 10.2147/IJGM.S461765. eCollection 2024.
BACKGROUND
Dilated cardiomyopathy (DCM) is a severe heterogeneous cardiomyopathy characterized by cardiac enlargement and declining heart function, often leading to refractory heart failure and life-threatening outcomes, particularly prevalent in China. The challenge lies in the scarcity of targeted therapies with substantial efficacy for DCM. Additionally, traditional anti-heart failure drugs are constrained due to hypotension propensity or limited symptom improvement. Kuoxin Formula (KXF), internally endorsed at Longhua Hospital, demonstrates clear biological evidence for enhancing cardiac function and myocardial remodeling. Previous clinical studies suggest its potential to enhance patients' quality of life. This trial aims to further evaluate KXF's safety and efficacy in managing DCM-related heart failure.
METHODS
This prospective, randomized, double-blind, placebo-controlled, multicenter trial aims to recruit 230 DCM patients from five centers. Participants will be randomly assigned to either KXF or placebo for 12 weeks, with careful monitoring of key indicators and adverse events. The primary outcome measures the proportion of patients with NT-proBNP reduction exceeding 30%. Secondary outcomes include New York Heart Association functional classification, Traditional Chinese Medicine syndrome scores, 6-minute walk test, Lee's heart failure score, and Minnesota Heart Failure Quality of Life Scale score. Ventricular remodeling will be assessed using cardiac ultrasound and ELISA. Safety metrics and adverse events will be meticulously recorded.
DISCUSSION
This study will be the first multicentered research conducted in China that utilizes a randomized, double-blind, placebo-controlled design to investigate the use of TCM in the treatment of DCM. It seeks to develop new theoretical frameworks and provide solid clinical data to support the integration of TCM and modern medicine in treating heart failure in DCM patients.
TRIAL REGISTRATION
China Clinical Trial Registry, ChiCTR2300068937. Registered on March 1, 2023. https://www.chictr.org.cn/bin/project/edit?pid=190926.
背景
扩张型心肌病（DCM）是一种严重的异质性心肌病，其特征为心脏扩大和心功能下降，常导致难治性心力衰竭和危及生命的后果，在中国尤为普遍。挑战在于缺乏对DCM有显著疗效的靶向治疗方法。此外，传统抗心力衰竭药物因有导致低血压的倾向或症状改善有限而受到限制。龙华医院内部认可的扩心方（KXF）显示出增强心功能和心肌重塑的明确生物学证据。先前的临床研究表明其有提高患者生活质量的潜力。本试验旨在进一步评估KXF治疗DCM相关心力衰竭的安全性和有效性。
方法
这项前瞻性、随机、双盲、安慰剂对照、多中心试验旨在从五个中心招募230名DCM患者。参与者将被随机分配接受KXF或安慰剂治疗12周，同时仔细监测关键指标和不良事件。主要结局指标为N末端B型利钠肽原（NT-proBNP）降低超过30%的患者比例。次要结局指标包括纽约心脏病协会（NYHA）心功能分级、中医证候评分、6分钟步行试验、李氏心力衰竭评分和明尼苏达心力衰竭生活质量量表评分。将使用心脏超声和酶联免疫吸附测定（ELISA）评估心室重塑。将仔细记录安全性指标和不良事件。
讨论
本研究将是中国首次采用随机、双盲、安慰剂对照设计来研究中医治疗DCM的多中心研究。它旨在建立新的理论框架，并提供可靠的临床数据，以支持中医与现代医学相结合治疗DCM患者的心力衰竭。
试验注册
中国临床试验注册中心，ChiCTR2300068937。于2023年3月1日注册。https://www.chictr.org.cn/bin/project/edit?pid=190926。
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