Shensongyangxin Capsule in the Treatment of Sinus Bradycardia With Premature Ventricular Contractions — SS-SBVPT  

Premature Ventricular Contraction Clinical Trial

Official title: Shensongyangxin Capsule in the Treatment of Sinus Bradycardia With Premature Ventricular Contractions Multi-center,Randomized, Double-blind, Placebo-controlled Clinical Study

Status Enrolling by invitation

Clinical Trial Summary

The purpose of this study is to assess the effects of Chinese medicine Shansong Yangxin capsule for sinus bradycardia complicated with ventricular premature beats.

Clinical Trial Description

Premature ventricular contractions is one of the most common symptomatic arrhythmia. Antiarrhythmia drugs for premature ventricular contractions, such as beta-blockers and sodium channel blockers, can cause bradycardia. For sinus bradycardia patients complicated with premature ventricular contractions, it's hard for doctors to make decision. The purpose of the study is to assess the effects of Chinese medicine Shansong Yangxin capsule for sinus bradycardia complicated with ventricular premature beats, which based on the numbers of premature ventricular contractions and average hear rate in 24-hour ambulatory electrocardiogram (ECG) after 8 weeks treatment as the primary endpoint of the study. Secondary endpoints are evaluation of the Shensong Yangxin capsule on quality of life. This study is a randomized, double-blind, placebo controlled, multi-center trial. Sinus bradycardia patients(average heart rate 45-59 beat per minute) associated with premature ventricular contractions (PVC number >10000 / 24h), are involved in the study. Patients are randomly assigned into Shensong Yangxin capsule group or placebo group, with the capsule administration of 4 granules t.i.d.for 8 weeks. 24-hour ambulatory ECG, are observed at baseline,4 weeks and 8 weeks after the intervention. The primary outcomes are the numbers of premature ventricular contractions and average heat rate in 24-hour ambulatory ECG, and the secondary outcomes is Minnesota living with heart failure questionnaire (MLHFQ). ;

Study Design

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

Related Conditions & MeSH terms

• Bradycardia
• Premature Birth
• Premature Ventricular Contraction
• Ventricular Premature Complexes

• NCT number: NCT01750775
• Study type: Interventional
• Source: The First Affiliated Hospital with Nanjing Medical University
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: August 2012
• Completion date: December 2013