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

Cong-xin Huang

Status and phase: Unknown; Phase 4

Conditions: Ventricular Premature Complex; Heart Failure

Treatments: Drug: Shensong Yangxin capsule; Drug: placebo Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT01612260

2012CB518600（2012CB518606） (Other Grant/Funding Number)

yl-yxb06-lcsyfa-201201

Details and patient eligibility

About

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.

Full 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).

Enrollment: 460 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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460 participants in 2 patient groups, including a placebo group

Shensong Yangxin capsule

Experimental group

Description:

Shensong Yangxin capsule 4 granules t.i.d. po for 12weeks

Treatment:

Drug: Shensong Yangxin capsule

placebo Capsule

Placebo Comparator group

Description:

placebo Capsule 4 granules t.i.d. po for 12weeks

Treatment:

Drug: placebo Capsule