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 Wang; Dan HU; Song Dang; He Huang; Cong-xin Huang; Ming-jie Yuan; Yan-hong Tang; Qing-shan Zheng; Fang Yin; Shu Zhang; Bo-li Zhang; Run-lin Gao; Null

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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.

Author: Xi WANG ¹ ; Dan HU ² ; Song DANG ¹ ; He HUANG ¹ ; Cong-Xin HUANG ¹ ; Ming-Jie YUAN ¹ ; Yan-Hong TANG ¹ ; Qing-Shan ZHENG ³ ; Fang YIN ³ ; Shu ZHANG ⁴ ; Bo-Li ZHANG ⁵ ; Run-Lin GAO ⁴ ; null
Author Information

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
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.
Publication Type:Journal Article
From: Chinese Medical Journal 2017;130(14):1639-1647
CountryChina
Language:English
Abstract:
BACKGROUNDPharmacological 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).
METHODSThis 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).
RESULTSThe 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.
CONCLUSIONSIn 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 REGISTRATIONwww.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).