title: Clinical assessment of Shenfu injection loading in the treatment of patients with exacerbation of chronic heart failure due to coronary heart disease: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Acute exacerbation is a common cause of hospitalization in patients with chronic heart failure, and coronary heart disease is the most common cause. Shenfu injection, a Traditional Chinese Medicine injection, widely used in the adjuvant treatment of patients with acute exacerbation of chronic heart failure, shows some treatment effect in improving the symptoms and the quality of life, but it lacks the rigorous clinical evaluation of research reports. This paper describes the protocol for the clinical assessment of Shenfu injection loading in the treatment of patients with acute exacerbation of chronic heart failure.
  
  
  METHODS
  This protocol adopts the design of a prospective, randomized, multicenter, blind imitation, placebo-controlled trial to assess the efficacy and safety of Shenfu injection loading in the treatment of patients with acute exacerbation of chronic heart failure due to coronary heart disease. The research will be carried out in 12 hospitals in China and is expected to enroll 160 inpatients with acute exacerbation of chronic heart failure due to coronary heart disease (yang and qi deficiency syndrome). On the basis of the conventional therapy of western medicine, patients will be randomized to either the treatment group (100 ml 5% glucose injection + 50 ml Shenfu injection) or the control group (150 ml 5% glucose injection) for 7 ± 1 days and follow-up for 28 ± 3 days. The primary outcomes are New York Heart Association cardiac function classification and Traditional Chinese Medicine syndromes. The secondary outcomes are left ventricular ejection fraction, brain natriuretic peptide level, Lee's heart failure score, 6-minute walking distance, and the incidence and readmission rate of cardiovascular events (including the emergency rate due to acute exacerbation of chronic heart failure).
  
  
  CONCLUSIONS
  This trial will assess the effect of loading Shenfu injection in the treatment of patients with acute exacerbation of chronic heart failure caused by coronary heart disease (yang-qi deficiency syndrome) on the symptoms and signs of heart failure, exercise tolerance, and other aspects, and observe its influence on the short-term prognosis with follow-up. The results of the study will provide clinical research evidence for application of Shenfu injection in the treatment.
  
  
  BACKGROUND
  This trial was registered on 26 December 2012 at the Chinese Clinical Trials Register (Identifier: ChiCTR-TRC-12002857 ).
authors.affiliation: Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, 312 Anshan Western Road, Nankai District, Tianjin, 300193, China. liuchunxiangebm@foxmail.com.
authors.forename: Chunxiang
authors.initials: C
authors.lastname: Liu
authors.affiliation: Cardiovascular Department of The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, 314 Anshan Western Road, Tianjin, Nankai District, Tianjin, 300193, China. mreleven@163.com.|Tianjin University of Traditional Chinese Medicine, 312 Anshan Western Road, Nankai District, Tianjin, 300193, China. mreleven@163.com.
authors.forename: Yazhu
authors.initials: Y
authors.lastname: Hou
authors.affiliation: Cardiovascular Department of The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, 314 Anshan Western Road, Tianjin, Nankai District, Tianjin, 300193, China. xlwang1981@126.com.
authors.forename: Xianliang
authors.initials: X
authors.lastname: Wang
authors.affiliation: Cardiovascular Department of The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, 314 Anshan Western Road, Tianjin, Nankai District, Tianjin, 300193, China. quanmingzhao@126.com.
authors.forename: Zhiqiang
authors.initials: Z
authors.lastname: Zhao
authors.affiliation: Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, 312 Anshan Western Road, Nankai District, Tianjin, 300193, China. liuz_ebm@foxmail.com.
authors.forename: Zhi
authors.initials: Z
authors.lastname: Liu
authors.affiliation: Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, 312 Anshan Western Road, Nankai District, Tianjin, 300193, China. zhaijingbo@foxmail.com.
authors.forename: Jingbo
authors.initials: J
authors.lastname: Zhai
authors.affiliation: Cardiovascular Department of The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, 314 Anshan Western Road, Tianjin, Nankai District, Tianjin, 300193, China. jymao@126.com.
authors.forename: Jingyuan
authors.initials: J
authors.lastname: Mao
authors.affiliation: Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, 312 Anshan Western Road, Nankai District, Tianjin, 300193, China. shanghongcai@foxmail.com.|Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China. shanghongcai@foxmail.com.
authors.forename: Hongcai
authors.initials: H
authors.lastname: Shang
mesh_terms: D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002681:China; D002908:Chronic Disease; D002985:Clinical Protocols; D003327:Coronary Disease / Q000150:complications* / Q000175:diagnosis; D018450:Disease Progression; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects; D005080:Exercise Test; D017079:Exercise Tolerance / Q000187:drug effects; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D020097:Natriuretic Peptide, Brain / Q000097:blood; D010359:Patient Readmission; D010865:Pilot Projects; D011446:Prospective Studies; D020127:Recovery of Function; D012107:Research Design; D013318:Stroke Volume / Q000187:drug effects; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left / Q000187:drug effects; D016138:Walking
chemical_list: D015415:Biomarkers; D002317:Cardiovascular Agents; D004365:Drugs, Chinese Herbal; C492793:Shen-Fu; D020097:Natriuretic Peptide, Brain