Shensongyangxin Capsule in the Treatment of Sinus Bradycardia With Premature Ventricular Contractions

Premature Ventricular Contraction Clinical Trial

— SS-SBVPT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01750775
• Other study ID #: yl-yxb07-lcsyfa-201202
• Secondary ID: ChiCTR-TRC-12002
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: December 6, 2012
• Last updated: December 13, 2012
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2012
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 330
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18 Years to 70 Years old

• Documented sinus bradycardia with average heart rate at 45-59 by 24hours ambulatory EKG

• Ventricular premature beats: >1000 beats/24 hours

Exclusion Criteria:

• Younger than 18 years or older than 75 years

• Symptomatic sinus arrest >3 seconds or high degree atrioventricular block indicated for pacemaker

• 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, or paroxysmal atrial fibrillation >5% during 24hrs ambulatory EKG 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 ICD,CRTP/D

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

Intervention

Drug:
• Shensong Yangxin capsule
ShenSongYangXin Capsule 4 granules t.i.d. by mouth for 8 weeks
• placebo Capsule
placebo Capsule 4 granules t.i.d. by mouth for 8 weeks

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Nanjing Medical Universtiy	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
kejiang Cao	Chinese Academy of Medical Sciences, Fuwai Hospital, Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Minnesota living with heart failure questionnaire (MLHFQ)		8 weeks	No
Primary	numbers of the Premature ventricular contractions detected by 24 houres ambulatory EKG		8 weeks	No
Primary	average heart rate detected by 24-hour ambulatory ECG		8 weeks	No
Secondary	numbers of the Premature ventricular contractions detected by 24-hour ambulatory ECG		4 weeks	No
Secondary	average heart rate detected by 24-hour ambulatory ECG		4 weeks	No

External Links

•   the website of the first affiliated hospital with nanjing medical university