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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Wuhan University
Sponsor:
Collaborators:
Cardiovascular Institute & Fuwai Hospital
Fudan University
Shanghai Changzheng Hospital
Nanjing Medical University
Third Military Medical University
Information provided by (Responsible Party):
Cong-xin Huang, Wuhan University
ClinicalTrials.gov Identifier:
NCT01612260
First received: May 24, 2012
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Heart Failure
Ventricular Premature Complex
Drug: Shensong Yangxin capsule
Drug: placebo Capsule
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Wuhan University:

Primary Outcome Measures:
  • numbers of the Premature ventricular contractions during 24-hour ambulatory ECG [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • NYHA classification [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • LVEF [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • NT-proBNP [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Minnesota living with heart failure questionnaire (MLHFQ) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • 6 minute walking test [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • LVEDD [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 460
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Shensong Yangxin capsule
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
Other Name: 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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612260

Contacts
Contact: Cong-xin Huang, PH D 13907131546 huangcongxin@yahoo.com.cn
Contact: Xi Wang 15994207265 xiwangwhu@16..com

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

No publications provided

Responsible Party: Cong-xin Huang, professor, Wuhan University
ClinicalTrials.gov Identifier: NCT01612260     History of Changes
Other Study ID Numbers: yl-yxb06-lcsyfa-201201, 2012CB518600(2012CB518606)
Study First Received: May 24, 2012
Last Updated: January 7, 2013
Health Authority: China: Ethics Committee

Keywords provided by Wuhan University:
heart failure
ventricular premature complex
Shensong Yangxin capsule

Additional relevant MeSH terms:
Heart Failure
Ventricular Premature Complexes
Cardiac Complexes, Premature
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014