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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.
Trials. 2015 May 21; 16:222.T

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).

DISCUSSION

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.

TRIAL REGISTRATION

This trial was registered on 26 December 2012 at the Chinese Clinical Trials Register (Identifier: ChiCTR-TRC-12002857).

Authors+Show Affiliations

Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, 312 Anshan Western Road, Nankai District, Tianjin, 300193, China. liuchunxiangebm@foxmail.com.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.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.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.Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, 312 Anshan Western Road, Nankai District, Tianjin, 300193, China. liuz_ebm@foxmail.com.Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, 312 Anshan Western Road, Nankai District, Tianjin, 300193, China. zhaijingbo@foxmail.com.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.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.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25994188

Citation

Liu, Chunxiang, et al. "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." Trials, vol. 16, 2015, p. 222.
Liu C, Hou Y, Wang X, et al. 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. Trials. 2015;16:222.
Liu, C., Hou, Y., Wang, X., Zhao, Z., Liu, Z., Zhai, J., Mao, J., & Shang, H. (2015). 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. Trials, 16, 222. https://doi.org/10.1186/s13063-015-0729-7
Liu C, et al. 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. Trials. 2015 May 21;16:222. PubMed PMID: 25994188.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Liu,Chunxiang, AU - Hou,Yazhu, AU - Wang,Xianliang, AU - Zhao,Zhiqiang, AU - Liu,Zhi, AU - Zhai,Jingbo, AU - Mao,Jingyuan, AU - Shang,Hongcai, Y1 - 2015/05/21/ PY - 2014/11/17/received PY - 2015/04/23/accepted PY - 2015/5/22/entrez PY - 2015/5/23/pubmed PY - 2016/2/5/medline SP - 222 EP - 222 JF - Trials JO - Trials VL - 16 N2 - 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). DISCUSSION: 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. TRIAL REGISTRATION: This trial was registered on 26 December 2012 at the Chinese Clinical Trials Register (Identifier: ChiCTR-TRC-12002857). SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/25994188/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_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0729-7 DB - PRIME DP - Unbound Medicine ER -