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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01612260
• Other study ID #: yl-yxb06-lcsyfa-201201
• Secondary ID: 2012CB518600(201
• Status: Recruiting
• Phase: Phase 4
• First received: May 24, 2012
• Last updated: January 7, 2013
• Start date: September 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2013
• Source: Wuhan University
• Contact: Cong-xin Huang, PH D
• Phone: 13907131546
• Email: huangcongxin[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Heart Failure
• Premature Birth
• Ventricular Premature Complex
• Ventricular Premature Complexes

Intervention

Drug:
• Shensong Yangxin capsule
ShenSongYangXin Capsule 4 granules t.i.d. po for 12weeks
• placebo Capsule
4 granules t.i.d. po for 12 weeks

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital University of Medical Sciences	Beijing	Beijing
China	China-Japan Freindship Hospital	Beijing	Beijing
China	Westchinahospital,Sichuanuniversity	Chengdu	Sichuan
China	Chongqing Zhongshan Hospital	Chongqing	Chongqing
China	Enshi Autonomous Region Central Hospital	Enshi	Hubei
China	Traffic hospitals of Shandong Province	Jinan	Shandong
China	Jingzhou Central Hospital	Jingzhou	Hubei
China	First hospital Affiliated to Nanjing Medical University	Nanjing	Jiangsu
China	Nanjing Drum Tower Hospital,The Affiliated hospital of Nanjing University Medical school	Nanjing	Jiangsu
China	First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Ruijin Hospital, Shanghai Jiaotong University	Shanghai	Shanghai
China	Shanghai First People's Hospital	Shanghai	Shanghai
China	Zhongshan Hospital of Fudan University	Shanghai	Shanghai
China	The General Hospital of Shenyang Military Region	Shenyang	Liaoning
China	The first hospital of Hebei Medical University	Shijiazhuang	Hebei
China	General Hospital of Dongfeng Motor Corporation	Shiyan	Hubei
China	Wuhan Asia Heart Hospital	Wuhan	Hubei
China	Xiangyang Central Hospital	Xiangyang	Hubei
China	The First College of Clinical Medical Science, China Three Gorges University	Yichang	Hubei
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (6)

Lead Sponsor	Collaborator
Cong-xin Huang	Chinese Academy of Medical Sciences, Fuwai Hospital, Fudan University, Nanjing Medical University, Shanghai Changzheng Hospital, Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	numbers of the Premature ventricular contractions during 24-hour ambulatory ECG		3 months	Yes
Secondary	NYHA classification		3 months	Yes
Secondary	LVEF		3 months	Yes
Secondary	NT-proBNP		3 months	Yes
Secondary	Minnesota living with heart failure questionnaire (MLHFQ)		3 months	Yes
Secondary	6 minute walking test		3 months	Yes
Secondary	LVEDD		3 months	Yes