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A multi-center, randomized, double-blind, placebo-parallel controlled trial for the efficacy and safety of shenfuqiangxin pills in the treatment of chronic heart failure (Heart-Kidney yang deficiency syndrome)(Open Access)

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机构: [a]National Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences, [b]National Priority R & D Programmes (2018YFC1707410-02), Xiyuan Clinical Medical College of Beijing University of Chinese Medicine, [c]National priority R & Dprogrammes (2018YFC1707410-02), Fuwai Hospital of Chinese Academy of Medical Sciences, [d]National Priority R & D Programmes (2018YFC1707410-02), XuanwuHospital Capital Medical University, Beijing, China.
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关键词: chronic heart failure protocol shenfu qiangxin pills traditional Chinese medicine

摘要:
BACKGROUND: Heart failure (HF) is the final stage of various cardiac diseases with poor prognosis. The integrated traditional Chinese medicine (TCM) and western medicine therapy has been considered as a prospective therapeutic strategy for chronic heart failure (CHF). There have been small clinical trials and experimental studies to demonstrate the efficacy of Shenfu Qiangxin Pills (SFQX) for treating CHF, however, there is still a lack of further high-quality trial. This paper describes the protocol for the clinical assessment of SFQX in CHF (heart-kidney Yang deficiency syndrome) patients. METHODS: A randomized, double-blind, parallel-group, placebo-controlled, multi-center trial will assess the efficacy and safety of SFQX in the treatment of CHF. 352 patients with CHF (heart-kidney Yang deficiency syndrome) from 22 hospitals in China will be enrolled. Besides their standardized western medicine, patients will be randomized to receive treatment of either SFQX or placebo for 12 weeks. The primary outcome is the plasma N-terminal pro-B-type natriuretic peptide levels, which will be measured uniformly by the central laboratory. The secondary outcomes include composite endpoint events (hospitalization due to worsening HF, all-cause mortality, other serious cardiovascular events), echocardiography indicators, grades of the New York Heart Association (NYHA) functional classification, the 6-minute walk test (6MWT) results, Minnesota Living With Heart Failure Questionnaire and TCM syndrome scores. DISCUSSION: The integrated TCM and western medicine therapy has developed into a treatment model in China. The rigorous design of the trial will assure an objective and scientific assessment of the efficacy and safety of SFQX in the treatment of CHF. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2000028777 (registered on January 3, 2020).Abbreviations: CHF = chronic heart failure, CRF = Case Record Form, EDC = Electronic Data Capture, HF = Heart Failure, HFrEF= heart failure with reduced ejection fraction, LVEF = left ventricular ejection fraction, MLHFQ = Minnesota Living With Heart Failure questionnaire, NT-proBNP = N-terminal pro-B-type natriuretic peptide, NYHA = New York Heart Association, SFQX = Shenfu qiangxin pills, TCM = traditional Chinese medicine.

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出版当年[2019]版:
大类 | 4 区 医学
小类 | 3 区 医学:内科
最新[2023]版:
大类 | 4 区 医学
小类 | 4 区 医学:内科
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出版当年[2018]版:
Q2 MEDICINE, GENERAL & INTERNAL
最新[2023]版:
Q2 MEDICINE, GENERAL & INTERNAL

影响因子: 最新[2023版] 最新五年平均 出版当年[2018版] 出版当年五年平均 出版前一年[2017版] 出版后一年[2019版]

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第一作者机构: [a]National Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences, [b]National Priority R & D Programmes (2018YFC1707410-02), Xiyuan Clinical Medical College of Beijing University of Chinese Medicine,
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通讯机构: [*1]Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, China
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