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Assessment of Complementary Treatment with Yiqi Fumai Lyophilized Injection on Acute Decompensated Ischemic Heart Failure (ACT-ADIHF): Rationale and Design of a Multicenter, Randomized, Controlled Trial

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Abstract

Background

Heart failure (HF) is the end stage of many heart diseases, and ischemic heart disease (IHD) is the primary cause. Yiqi Fumai lyophilized injection, a contemporary Chinese medicine preparation, widely used in the treatment of IHF patients, shows clinical efficacy on improving symptoms and cardiac function, but the quality of the current literature does not address multiple important issues. This article describes a protocol for assessment of complementary treatment with Yiqi Fumai lyophilized injection in acute decompensated IHD.

Methods

The protocol is designed as a multicenter randomized controlled trial to assess the efficacy and safety of complementary treatment with Yiqi Fumai lyophilized injection on acute decompensated IHD. This trial will be carried out in 37 hospitals in China and expected to enroll 666 inpatients with acute decompensated IHF due to coronary heart disease. On the basis of standardized western medications, patients are randomized to either the treatment group (250 ml 5% glucose / sodium injection + 5.2 g Yiqi Fumai lyophilized injection) or the control group for 7 days and follow-up for 30 ± 3 and 60 ± 3 days. The primary outcome is change in brain natriuretic peptide (BNP) concentrations. The secondary outcomes are composite endpoint, left ventricular ejection fraction, blood troponin T/I, cardiothoracic ratio, life quality scale, scores of the four traditional Chinese medicine (TCM) diagnostic methods.

Discussion

Standardized western medications together with TCM have been extensively used in China and have developed into a comprehensive treatment model. The trial will provide clinical research evidence for application of complementary treatment with intravenous Yiqi Fumai lyophilized injection on decompensated IHF.

Trial Registration

This study protocol has been listed in the Chinese Clinical Trial Registry (registration number: ChiCTR-IPR-15007396, http://www.chictr.org.cn/showproj.aspx?proj=12370) on November 6, 2015.

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Acknowledgements

The authors would like to thank the following participating organizations: First Teaching Hospital of Tianjin University of TCM, Second Affiliated Hospital of Tianjin University of TCM, Tianjin Hospital of ITCWM Nankai Hospital, The Second Hospital of Tianjin Medical University, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, The First Affiliated Hospital of Anhui University of Chinese Medicine, Wuhu Hospital of Traditional Chinese Medicine, Gansu University of Chinese Medicine, Yinchuan Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Changchun University of Chinese Medicine, The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Inner Mongolia People’s Hospital, Hohhot First Hospital, The Second Affiliated Hospital of Baotou Medical College, The First Affiliated Hospital of Henan University of TCM, Henan Province Hospital of TCM, The First Affiliated Hospital of Henan University, Zhengzhou City Hospital of Traditional Chinese Medicine, BenQ Medical Center, The Affiliated Hospital of Jiangxi University of Chinese Medicine, Shanxi Province Hospital of TCM, Shanxi Hospital of Integrated Traditional And Western Medicine, Shaanxi Province Hospital of Chinese Medicine, The Second Teaching Hospital of Shaanxi University of TCM, The Affiliated Hospital of Shaanxi University of Chinese Medicine, Xinjiang Uygur Autonomous Region Chinese Medicine Hospital, The First Affiliated Hospital of Xinjiang Medical University, Guangdong Province Hospital of TCM, LongHua Hospital Shanghai University of Traditional Chinese Medicine, Shuguang Hospital Affiliated to Shanghai University of TCM, Shanghai East Hospital Affiliated to Tongji University, Chengdu Hospital Affiliated to Chengdu University of TCM, The First Hospital of Harbin, Panjin Center Hospital, Sanming Hospital of Integrated Traditional and Western, Wuhan Puren Hospital.

Funding

This study is supported by the Ministry of Science and Technology of the People’s Republic of China’s Key Projects in the National Science & Technology Pillar Program during the Twelfth Five-year Plan Period (NO. 2013BAI02B02), Ministry of Education of People’s Republic of China “Program for Innovative Research Team in University” (NO. IRT_16R54), and Tianjin Science and Technology Program (No. 15ZXLCSY00020).

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Author notes

  1. Xianliang Wang and Zhiqiang Zhao contributed equally to this work.

Authors and Affiliations

  1. Cardiovascular Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300381, China

    Xianliang Wang, Zhiqiang Zhao, Yazhu Hou, E. Tang, Guoyuan Zhao, Shuai Wang, Yingfei Bi, Chengliang Zhong, Jingyuan Mao & Boli Zhang

  2. Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China

    Ming Ren, Junhua Zhang & Boli Zhang

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  1. Xianliang Wang
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Corresponding authors

Correspondence to Jingyuan Mao or Boli Zhang.

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Conflict of Interest

The authors declare that they have no conflict of interest.

Ethical Approval

This study is conducted in accordance with the Declaration of Helsinki and has been approved by the ethics committee in First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (Ethics approval number: TYLL2015[K] No.004).

Informed Consent

Written informed consent was obtained from all patients or their legally authorized representatives before randomization.

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Wang, X., Zhao, Z., Hou, Y. et al. Assessment of Complementary Treatment with Yiqi Fumai Lyophilized Injection on Acute Decompensated Ischemic Heart Failure (ACT-ADIHF): Rationale and Design of a Multicenter, Randomized, Controlled Trial. Cardiovasc Drugs Ther 32, 295–300 (2018). https://doi.org/10.1007/s10557-018-6791-0

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