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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Heart Failure, Ventricular Premature Complex

Intervention / Treatment
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* Drug: Shensong Yangxin capsule
* Drug: placebo Capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shensong Yangxin capsule<br>Shensong Yangxin capsule 4 granules t.i.d. po for 12weeks | Drug: Shensong Yangxin capsule<br>* ShenSongYangXin Capsule 4 granules t.i.d. po for 12weeks<br>|
| Placebo Comparator: placebo Capsule<br>placebo Capsule 4 granules t.i.d. po for 12weeks | Drug: placebo Capsule<br>* 4 granules t.i.d. po for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, ventricular premature complex, Shensong Yangxin capsule