Shensong Yangxin Capsule in the Treatment of Heart Failure Complicated With Ventricular Premature Beat

Shensong Yangxin Capsule in the Treatment of Mild to Moderate Systolic Heart Failure Complicated With Ventricular Premature Beat: A Randomize, Double Blind, Placebo-controlled Multicenter Clinical Trial

The purpose of this study is to assess the effects of Chinese medicine Shensong Yangxin capsule for the chronic cardiac dysfunction complicated with ventricular premature beats.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Ventricular Premature Complex
• Intervention / Treatment: Drug: Shensong Yangxin capsule; Drug: placebo Capsule

Detailed Description

Premature ventricular contractions is one of the most common arrhythmia in the patients with structural heart disease and heart failure, which is not only has the high incidence but also has a high predictive value of sudden death. The purpose of the study is to assess the effects of Chinese medicine Shensong Yangxin capsule for the chronic cardiac dysfunction complicated with ventricular premature beats, which based on the numbers of premature ventricular contractions in 24-hour ambulatory electrocardiogram (ECG) as the main endpoint of the study. Secondary endpoints are evaluation of the Shensong Yangxin capsule on cardiac function and quality of life. This study is a randomized, double-blind, placebo controlled, multi-center trial. Chronic heart failure patients(cardiac function is Class II-III) associated with premature ventricular contractions (premature number 720-10000 / 24h), who received standardized treatment for heart failure at least three months, were involved in the study. Patients were randomly assigned into Shensong Yangxin capsule group or placebo group, with the capsule administration of 4 granules t.i.d.for 12 weeks. 24-hour ambulatory ECG, echocardiography and evaluation of heart function were observed at baseline and 12 weeks after the intervention. The primary outcomes are the numbers of premature ventricular contractions in 24-hour ambulatory ECG, and the secondary outcomes are New York Heart Association (NYHA) classification, NT-proBNP, left ventricular ejection fraction (LVEF) and left ventricular end-diastolic dimension (LVEDD, 6 minute walking test and Minnesota living with heart failure questionnaire (MLHFQ).

• Study Type: Interventional
• Enrollment (Anticipated): 460
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Cong-xin Huang, PH D; Phone Number: 13907131546; Email: huangcongxin@yahoo.com.cn
• Study Contact Backup: Name: Xi Wang; Phone Number: 15994207265; Email: xiwangwhu@16..com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Beijing Anzhen Hospital, Capital University of Medical Sciences
      • Contact: changsheng Ma, PH D; Phone Number: 13901357404
    • Beijing, Beijing, China, 100000
      • Recruiting
      • China-Japan Freindship Hospital
      • Contact: yong Wang, PH D; Phone Number: 13801239117
  • Chongqing
    • Chongqing, Chongqing, China, 404100
      • Recruiting
      • Chongqing Zhongshan Hospital
      • Contact: xia Mei, PH D; Phone Number: 13508322668
  • Guangxi
    • Nanning, Guangxi, China, 530000
      • Recruiting
      • First Affiliated Hospital of Guangxi Medical University
      • Contact: weifeng Wu, PH D; Phone Number: 13907719960; Email: wucna@yahoo.com.cn
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • The First Hospital of Hebei Medical University
      • Contact: yue Xia, PH D
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: chunguang Qiu, PH D; Phone Number: 13803898806
  • Hubei
    • Enshi, Hubei, China, 445000
      • Recruiting
      • Enshi Autonomous Region Central Hospital
      • Contact: yuanhong Li, PH D; Phone Number: 13986843863
    • Jingzhou, Hubei, China, 434000
      • Recruiting
      • Jingzhou Central Hospital
      • Contact: xin Li, PH D; Phone Number: 13872347567
    • Shiyan, Hubei, China, 442000
      • Recruiting
      • General Hospital of Dongfeng Motor Corporation
      • Contact: handong Yang, PH D; Phone Number: 13807285189
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Wuhan Asia Heart Hospital
      • Contact: yangyang Dai, PH D; Phone Number: 15327411241
    • Xiangyang, Hubei, China, 441000
      • Recruiting
      • Xiangyang Central Hospital
      • Contact: wenwei Liu, PH D; Phone Number: 13907279669
    • Yichang, Hubei, China, 443000
      • Recruiting
      • The First College of Clinical Medical Science, China Three Gorges University
      • Contact: jun Yang, PH D; Phone Number: 13972561866
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • First Hospital Affiliated to Nanjing Medical University
      • Contact: jiangang Zou, PH D; Phone Number: 13605191407; Email: jgzou@njmu.edu.cn
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
      • Contact: wei Xu, PH D; Phone Number: 13390900868; Email: xuwei2003@medmail.com.cn
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • Recruiting
      • The General Hospital Of Shenyang Military Region
      • Contact: zulu Wang, PH D; Phone Number: 13309824590; Email: wangzl@medmail.com.cn
  • Shandong
    • Jinan, Shandong, China, 250000
      • Recruiting
      • Traffic hospitals of Shandong Province
      • Contact: tian Wang, PH D
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai First People's Hospital
      • Contact: fang Wang, PH D; Phone Number: 13621950918; Email: onlyfang2@gmail.com
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Ruijin Hospital, Shanghai Jiaotong University
      • Contact: liqun Wu, PH D; Phone Number: 13801621534; Email: wuliquan89@hotmail.com
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Zhongshan Hospital of Fudan University
      • Contact: yunzeng Zou, PH D; Phone Number: 13817702933
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • Westchinahospital,Sichuanuniversity
      • Contact: dejia Huang, PH D; Phone Number: 13908181686

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with cardiac function NYHA II~III, Left ventricular ejection fraction (LVEF) 35%~50% tested by Modified Simpson, has a stable hemodynamics and no need to deliver treatment through vein
• To be treated by standard treatment of heart failure at least 3 months with a stable dosage already
• Ventricular premature beats: 720-10000 beats/24 hours
• Heart failure caused by ischemic heart disease, or dilated cardiomyopathy

Exclusion Criteria:

• Subject to be expected to alive no more than 6 months
• Subject suffered from acute coronary syndrome in last three months (Acute myocardial infarction of ST segment elevation and non ST segment elevation, unstable angina
• To be complicated with persistent atrial fibrillation, atrioventricular conduction block (II degree of Type II or III degree), or acute myocarditis
• To be complicated with ventricular fibrillation, torsion type ventricular heartbeat rate, sustained ventricular tachycardia, or non sustained ventricular tachycardia with rapid ventricular rate and hemodynamic disorders
• Sinus heart rate less than 45 beats/minutes and needs to receive the pacemaker or has received pacemaker, or with abnormal sinus node function
• The hypertension, diabetes difficult to be controlled

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shensong Yangxin capsule; Shensong Yangxin capsule 4 granules t.i.d. po for 12weeks	Drug: Shensong Yangxin capsule; ShenSongYangXin Capsule 4 granules t.i.d. po for 12weeks
Placebo Comparator: placebo Capsule; placebo Capsule 4 granules t.i.d. po for 12weeks	Drug: placebo Capsule; 4 granules t.i.d. po for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
numbers of the Premature ventricular contractions during 24-hour ambulatory ECG	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
NYHA classification	3 months
LVEF	3 months
NT-proBNP	3 months
Minnesota living with heart failure questionnaire (MLHFQ)	3 months
6 minute walking test	3 months
LVEDD	3 months

Collaborators and Investigators

• Sponsor: Cong-xin Huang
• Collaborators: Fudan University; Third Military Medical University; Chinese Academy of Medical Sciences, Fuwai Hospital; Nanjing Medical University; Shanghai Changzheng Hospital

Publications and helpful links

General Publications

• Wang X, Hu D, Dang S, Huang H, Huang CX, Yuan MJ, Tang YH, Zheng QS, Yin F, Zhang S, Zhang BL, Gao RL; Efficacy and Safety of Shensong Yangxin Capsules for Frequent VPCs in Congestive Heart Failure Study Group. 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. Chin Med J (Engl). 2017 Jul 20;130(14):1639-1647. doi: 10.4103/0366-6999.209906.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: May 24, 2012
• First Submitted That Met QC Criteria: June 4, 2012
• First Posted (Estimate): June 5, 2012

Study Record Updates

• Last Update Posted (Estimate): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 7, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: heart failure; ventricular premature complex; Shensong Yangxin capsule
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Heart Failure; Premature Birth; Cardiac Complexes, Premature; Ventricular Premature Complexes
• Other Study ID Numbers: yl-yxb06-lcsyfa-201201; 2012CB518600（2012CB518606） (Other Grant/Funding Number: National Basic Research Program of China（973 Program）)