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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Safety and efficacy of Qishen granules in patients with chronic heart failure: study protocol for a randomized controlled trial

Authors: Jinping Wang, Jun Shi, Jiawei Wei, Juan Wang, Kuo Gao, Xueli Li, Jianxin Chen, Shaojing Li, Huihui Zhao, Wei Wang

Published in: Trials | Issue 1/2017

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Abstract

Background

Chronic heart failure (CHF), the final stage of various cardiovascular diseases, is a major public health problem resulting in significant hospitalization rates, mortality, and huge health care costs despite advances in the treatment and management of heart failure and heart failure-related risk factors. Qishen granules (QSG), a Chinese herbal formula, is widely used by traditional Chinese medicine (TCM) practitioners to treat CHF. Several animal experimental studies have showed that QSG can significantly relieve the heart failure symptoms in CHF rat models. However, there is as yet no standard clinical trial to confirm this. Thus, the investigators are conducting this study to evaluate the efficacy and safety of QSG in a large, and varied population.

Methods/design

This study is designed as a randomized, placebo-controlled, multi-center, double-blind clinical trial with parallel groups. A total of 200 patients with CHF will be recruited and randomly allocated to either the QSG treatment group or the placebo group (in a 1:1 ratio). The patients will receive QSG or placebo granules twice a day for 12 weeks. The primary outcome is the proportion of patients in the QSG group, compared with the placebo group, demonstrating a more than 30% decrease in NT-proBNP level during 12 weeks of treatment. The secondary outcomes consist of composite cardiac events, New York Heart Association functional classification, 6-minute walking distance, left ventricular ejection fraction, patient quality of life, and the TCM syndrome integral scale.

Discussion

On a background of standard treatment, QSG may further reduce the levels of NT-proBNP. This trial will provide high-quality evidence on the efficacy and safety of QSG in treating CHF, thus providing reference for clinical application of QSG.

Trial registration

Clinical Trials.gov: NCT03027375. Registered on 16 January 2017.
Appendix
Available only for authorised users
Literature
1.
Ramrakha PS. Oxford handbook of cardiology[M]. England: Oxford University Press; 2012.
2.
Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, et al. Executive summary: heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016;133(4):447–54.CrossRefPubMed
3.
Dokainish H, Teo K, Zhu J, Roy A, AlHabib KF, ElSayed A, et al. Global mortality variations in patients with heart failure: results from the International Congestive Heart Failure (INTER-CHF) prospective cohort study. Lancet Glob Health. 2017;5(7):e665–72.CrossRefPubMed
4.
Li X, Zhang J, Huang J, Ma A, Yang J, Li W, et al. A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the effects of qili qiangxin capsules in patients with chronic heart failure. J Am Coll Cardiol. 2013;62(12):1065–72.CrossRefPubMed
5.
Guo S, Li P, Fu B, Chuo W, Gao K, Zhang W, et al. Systems-biology dissection of mechanisms and chemical basis of herbal formula in treating chronic myocardial ischemia. Pharmacol Res. 2016;114:196–208.CrossRefPubMed
6.
Li C, Wang J, Wang Q, Zhang Y, Zhang N, Lu L, et al. Qishen granules inhibit myocardial inflammation injury through regulating arachidonic acid metabolism. Sci Rep. 2016;6:36949.CrossRefPubMedPubMedCentral
7.
Wang Y, Li C, Ouyang Y, Yu J, Guo S, Liu Z, et al. Cardioprotective effects of Qishenyiqi mediated by angiotensin II type 1 receptor blockade and enhancing angiotensin-converting enzyme 2. Evid Based Complement Alternat Med. 2012;2012:978127.PubMedPubMedCentral
8.
Wang Y, Liu Z, Li C, Li D, Ouyang Y, Yu J, et al. Drug target prediction based on the herbs components: the study on the multitargets pharmacological mechanism of qishenkeli acting on the coronary heart disease. Evid Based Complement Alternat Med. 2012;2012:698531.PubMedPubMedCentral
9.
Chou W, Guo S, Qiu Q, Wang Y, Li C, Lin Y. GW24-e2910 research on effects of Qishen granule on hemodynamics in mini pigs with cardiac functional insufficiency and Qi-deficiency and blood stasis syndrome induced by ameroid constricting ring. Heart. 2013;99 Suppl 3:A76.
10.
Chinese Society of Cardiology of Chinese Medical Association. Chinese guidelines for the diagnosis and treatment of heart failure 2014. Zhonghua Xin Xue Guan Bing Za Zhi. 2014;42(2):98–122.
11.
World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bull World Health Organ. 2001;79(4):373–4.
12.
Switula D. Principles of good clinical practice (GCP) in clinical research. Sci Eng Ethics. 2000;6(1):71–7.CrossRefPubMed
13.
Zhou K, Lin Q, Lu J, Nong Y, Wan J. Validities of Chronic Heart Failure Quality of Life Scale of Integrated Chinese and Western Medicine and SF-36 scale: a comparative study. J Anhui Tradit Chin Med Coll. 2013;32(02):30–34.
14.
Bettencourt P, Azevedo A, Pimenta J, Friões F, Ferreira S, Ferreira A. N-terminal-pro-brain natriuretic peptide predicts outcome after hospital discharge in heart failure patients. Circulation. 2004;110(15):2168–74.CrossRefPubMed
15.
Ferreira S, Almeida R, Guerrero H, Lourenço-Ferreira S, Fonseca L, Rocha R, et al. Prognosis of decompensated heart failure: role of NT-proBNP. Rev Port Cardiol. 2007;26(5):535–45.PubMed
16.
Weber KT. Cardiac interstitium in health and disease: the fibrillar collagen network. J Am Coll Cardiol. 1989;13(7):1637–52.CrossRefPubMed
17.
Weber KT, Sun Y, Bhattacharya SK, Ahokas RA, Gerling IC. Myofibroblast-mediated mechanisms of pathological remodelling of the heart. Nat Rev Cardiol. 2013;10(1):15–26.CrossRefPubMed
18.
Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE, Drazner MH, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;62(16):e147–239.CrossRefPubMed
19.
Wei CC, Hase N, Inoue Y, Bradley EW, Yahiro E, Li M, et al. Mast cell chymase limits the cardiac efficacy of Ang I-converting enzyme inhibitor therapy in rodents. J Clin Invest. 2010;120(4):1229–39.CrossRefPubMedPubMedCentral
20.
Singh VP, Le B, Khode R, Baker KM, Kumar R. Intracellular angiotensin II production in diabetic rats is correlated with cardiomyocyte apoptosis, oxidative stress, and cardiac fibrosis. Diabetes. 2008;57(12):3297–306.CrossRefPubMedPubMedCentral
21.
Li C, Wang Y, Qiu Q, Shi T, Wu Y, Han J, et al. Qishenyiqi protects ligation-induced left ventricular remodeling by attenuating inflammation and fibrosis via STAT3 and NF-κB signaling pathway. PLoS One. 2014;9(8):e104255.CrossRefPubMedPubMedCentral
Metadata
Title
Safety and efficacy of Qishen granules in patients with chronic heart failure: study protocol for a randomized controlled trial
Authors
Jinping Wang
Jun Shi
Jiawei Wei
Juan Wang
Kuo Gao
Xueli Li
Jianxin Chen
Shaojing Li
Huihui Zhao
Wei Wang
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2193-z

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