Effects of Traditional Chinese Medicine Shensong Yangxin Capsules on Heart Rhythm and Function in Congestive Heart Failure Patients with Frequent Ventricular Premature Complexes: A Randomized, Double-blind, Multicenter Clinical Trial
Xi Wang1, Dan Hu2, Song Dang1, He Huang1, Cong-Xin Huang1, Ming-Jie Yuan1, Yan-Hong Tang1, Qing-Shan Zheng3, Fang Yin3, Shu Zhang4, Bo-Li Zhang5, Run-Lin Gao4, for the Efficacy and Safety of Shensong Yangxin Capsules for Frequent VPCs in Congestive Heart Failure Study Group6
1 Department of Cardiology, Cardiovascular Research Institute, Renmin Hospital of Wuhan University, Wuhan University, Wuhan, Hubei 430060, China
2 Department of Cardiology, Cardiovascular Research Institute, Renmin Hospital of Wuhan University, Wuhan University, Wuhan, Hubei 430060, China; Department of Experimental Cardiology, Masonic Medical Research Laboratory, Utica, NY 13501, USA
3 Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
4 National Center for Cardiovascular Disease, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China
5 State Key Laboratory of Modern Chinese Medicine, College of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
Department of Cardiology, Cardiovascular Research Institute, Renmin Hospital of Wuhan University, Wuhan University, Wuhan, Hubei 430060
Source of Support: None, Conflict of Interest: None
Background: Pharmacological therapy for congestive heart failure (CHF) with ventricular arrhythmia is limited. In the study, our aim was to evaluate the effects of Chinese traditional medicine Shensong Yangxin capsules (SSYX) on heart rhythm and function in CHF patients with frequent ventricular premature complexes (VPCs).
Methods: This double-blind, placebo-controlled, multicenter study randomized 465 CHF patients with frequent VPCs to the SSYX (n = 232) and placebo groups (n = 233) for 12 weeks of treatment. The primary endpoint was the VPCs monitored by a 24-h ambulatory electrocardiogram. The secondary endpoints included the left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter, N-terminal pro-brain natriuretic peptide (NT-proBNP), New York Heart Association (NYHA) classification, 6-min walking distance (6MWD), Minnesota Living with Heart Failure Questionnaire (MLHFQ) scores, and composite cardiac events (CCEs).
Results: The clinical characteristics were similar at baseline. SSYX caused a significantly greater decline in the total number of VPCs than the placebo did (−2145 ± 2848 vs. −841 ± 3411, P < 0.05). The secondary endpoints of the LVEF, NYHA classification, NT-proBNP, 6MWD, and MLHFQ scores showed a greater improvements in the SSYX group than in the placebo group (ΔLVEF at 12th week: 4.75 ± 7.13 vs. 3.30 ± 6.53; NYHA improvement rate at the 8th and 12th week: 32.6% vs. 21.8%, 40.5% vs. 25.7%; mean level of NT-proBNP in patients with NT-proBNP ≥125 pg/ml at 12th week: −122 [Q1, Q3: −524, 0] vs. −75 [Q1, Q3: −245, 0]; Δ6MWD at 12th week: 35.1 ± 38.6 vs. 17.2 ± 45.6; ΔMLHFQ at the 4th, 8th, and 12th week: −4.24 ± 6.15 vs. −2.31 ± 6.96, −8.19 ± 8.41 vs. −3.25 ± 9.40, −10.60 ± 9.41 vs. −4.83 ± 11.23, all P < 0.05). CCEs were not different between the groups during the study period.
Conclusions: In this 12-week pilot study, SSYX was demonstrated to have the benefits of VPCs suppression and cardiac function improvement with good compliance on a background of standard treatment for CHF.
Trial Registration: www.chictr.org.cn, ChiCTR-TRC-12002061 (http://www.chictr.org.cn/showproj.aspx?proj=7487) and Clinicaltrials.gov, NCT01612260 (https://clinicaltrials.gov/ct2/show/NCT01612260).