PMID- 32481305
OWN - NLM
STAT- MEDLINE
DCOM- 20200618
LR  - 20221005
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 99
IP  - 21
DP  - 2020 May 22
TI  - 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).
PG  - e20271
LID - 10.1097/MD.0000000000020271 [doi]
LID - e20271
AB  - 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).
FAU - Guo, Lijun
AU  - Guo L
AD  - National Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease 
      Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.
AD  - National Priority R & D Programmes (2018YFC1707410-02), Xiyuan Clinical Medical 
      College of Beijing University of Chinese Medicine.
FAU - Yuan, Hui
AU  - Yuan H
AD  - National Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease 
      Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.
FAU - Zhang, Dawu
AU  - Zhang D
AD  - National Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease 
      Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.
FAU - Zhang, Jian
AU  - Zhang J
AD  - National priority R & D programmes (2018YFC1707410-02), Fuwai Hospital of Chinese 
      Academy of Medical Sciences.
FAU - Hua, Qi
AU  - Hua Q
AD  - National Priority R & D Programmes (2018YFC1707410-02), Xuanwu Hospital Capital 
      Medical University, Beijing, China.
FAU - Ma, Xiaochang
AU  - Ma X
AD  - National Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease 
      Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.
FAU - Chen, Keji
AU  - Chen K
AD  - National Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease 
      Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Drugs, Chinese Herbal)
RN  - 0 (Peptide Fragments)
RN  - 0 (Placebos)
RN  - 0 (Shen-Fu)
RN  - 0 (pro-brain natriuretic peptide (1-76))
RN  - 0 (qiangxin)
RN  - 114471-18-0 (Natriuretic Peptide, Brain)
SB  - IM
MH  - Case-Control Studies
MH  - China/epidemiology
MH  - Chronic Disease
MH  - Double-Blind Method
MH  - Drugs, Chinese Herbal/administration & dosage/adverse effects/*therapeutic use
MH  - Echocardiography/methods/statistics & numerical data
MH  - Heart/diagnostic imaging/physiopathology
MH  - Heart Failure/blood/*drug therapy/mortality/physiopathology
MH  - Hospitalization/trends
MH  - Humans
MH  - Medicine, Chinese Traditional/methods
MH  - Natriuretic Peptide, Brain/blood/drug effects
MH  - Peptide Fragments/blood/drug effects
MH  - Placebos/administration & dosage
MH  - Safety
MH  - Treatment Outcome
MH  - Walk Test/methods/statistics & numerical data
MH  - Yang Deficiency/complications/*drug therapy
PMC - PMC7249903
COIS- The authors report no conflicts of interest.
EDAT- 2020/06/03 06:00
MHDA- 2020/06/19 06:00
PMCR- 2020/05/22
CRDT- 2020/06/03 06:00
PHST- 2020/06/03 06:00 [entrez]
PHST- 2020/06/03 06:00 [pubmed]
PHST- 2020/06/19 06:00 [medline]
PHST- 2020/05/22 00:00 [pmc-release]
AID - 00005792-202005220-00060 [pii]
AID - MD-D-20-03033 [pii]
AID - 10.1097/MD.0000000000020271 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2020 May 22;99(21):e20271. doi: 
      10.1097/MD.0000000000020271.