title: Clinical assessment of complementary treatment with Qishen Yiqi dripping pills on ischemic heart failure: study protocol for a randomized, double-blind, multicenter, placebo-controlled trial (CACT-IHF).
abstract: BACKGROUND
  Heart failure (HF) is associated with decreased quality of life, high re-admission rate and poor prognosis. In particular, ischemic heart failure (IHF) has a worse prognosis than nonischemic HF. The use of traditional Chinese medicine (TCM) alongside Western medicine to treat HF has developed into an integrative treatment model in China. There have been small clinical trials and experimental studies to demonstrate the efficacy of TCM for treating HF; however, there is still a lack of high-quality trials. Qishen Yiqi dripping pills (QSYQ), a TCM drug, have been commonly used alongside standardized Western medicine to treat IHF. This paper describes the protocol for the clinical assessment of QSYQ in IHF patients.
  
  
  METHODS
  A randomized, double-blind, multicenter, placebo-controlled trial will assess the efficacy and safety of QSYQ in the treatment of IHF. The trial is to enroll 640 IHF patients from 32 hospitals in China. Besides their standardized Western medicine, patients will be randomized to receive treatment of either QSYQ or placebo for 6 months and follow-up monitoring for at least a further 6 months. The primary outcome is increased exercise capacity of patients, which will be measured using the 6-minute walking test (6MWT). The secondary outcomes include composite endpoints: all-cause mortality, frequency of hospitalization or emergency due to cardiovascular events, brain natriuretic peptide levels, left ventricular ejection fraction, and cardiothoracic ratio will be documented, as well as scores on the New York Heart Association classification and Minnesota quality of life index, and information obtained from the four TCM diagnostic methods. Blood lipid tests will also be administered.
  
  
  CONCLUSIONS
  The integrative treatment model of TCM alongside Western medicine 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 QSYQ in the treatment of IHF.
authors.affiliation: Cardiovascular Department of The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, 314 Anshan Western Road, Tianjin, Nankai District, China.
authors.forename: Ya Zhu
authors.initials: YZ
authors.lastname: Hou
authors.forename: Shuai
authors.initials: S
authors.lastname: Wang
authors.forename: Zhi Qiang
authors.initials: ZQ
authors.lastname: Zhao
authors.forename: Xian Liang
authors.initials: XL
authors.lastname: Wang
authors.forename: Bin
authors.initials: B
authors.lastname: Li
authors.forename: Shan Bin
authors.initials: SB
authors.lastname: Soh
authors.forename: Jing Yuan
authors.initials: JY
authors.lastname: Mao
mesh_terms: D015415:Biomarkers / Q000097:blood; D002317:Cardiovascular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005080:Exercise Test; D017079:Exercise Tolerance / Q000187:drug effects; D006333:Heart Failure / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality / Q000503:physiopathology; D006760:Hospitalization; D006801:Humans; D008055:Lipids / Q000097:blood; D017202:Myocardial Ischemia / Q000097:blood / Q000150:complications* / Q000401:mortality / Q000503:physiopathology; D020097:Natriuretic Peptide, Brain / Q000097:blood; D011237:Predictive Value of Tests; D011788:Quality of Life; 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; D008055:Lipids; C528580:qishen yiqi; D020097:Natriuretic Peptide, Brain