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

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

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

Study Overview

• Status: Unknown
• Conditions: Premature Ventricular Contraction
• Intervention / Treatment: Drug: Shensong Yangxin capsule; Drug: placebo Capsule

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 330
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • the First Affiliated Hospital of Nanjing Medical Universtiy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shensong Yangxin capsule; Shensong Yangxin capsule 4 granules t.i.d. by mouth for 8weeks	Drug: Shensong Yangxin capsule; ShenSongYangXin Capsule 4 granules t.i.d. by mouth for 8 weeks
Placebo Comparator: placebo Capsule; placebo Capsule 4 granules t.i.d. by mouth for 8 weeks	Drug: placebo Capsule; placebo Capsule 4 granules t.i.d. by mouth for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
numbers of the Premature ventricular contractions detected by 24 houres ambulatory EKG	8 weeks
average heart rate detected by 24-hour ambulatory ECG	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
numbers of the Premature ventricular contractions detected by 24-hour ambulatory ECG	4 weeks
average heart rate detected by 24-hour ambulatory ECG	4 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Minnesota living with heart failure questionnaire (MLHFQ)	8 weeks

Collaborators and Investigators

• Sponsor: kejiang Cao
• Collaborators: Third Military Medical University; Chinese Academy of Medical Sciences, Fuwai Hospital
• Investigators: Principal Investigator: Kejiang Cao, M.D, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

General Publications

• Zhang F, Zou J, Yu H, Li X, Kojodjojo P, Cai X, Zhang S, Huang C, Hong K, Yu B, Li G, Luo S, Zhou S, Zheng Y, Fan J, Cao X, Tao G, Sheng G, Bai Z, Jiang S, Liu X, Gu W, Chen F, Cao K. Acute Efficacy of a Traditional Chinese Medicine for Treatment of Frequent Premature Ventricular Contractions in Patients with Concomitant Sinus Bradycardia: Results from a Double-Blind, Placebo-Controlled, Multicentre, Randomized Clinical Trial. Evid Based Complement Alternat Med. 2019 Mar 4;2019:3917282. doi: 10.1155/2019/3917282. eCollection 2019.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: December 6, 2012
• First Submitted That Met QC Criteria: December 13, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Estimate): December 17, 2012
• Last Update Submitted That Met QC Criteria: December 13, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: sinus bradycardia; ventricular premature contraction
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Cardiac Complexes, Premature; Premature Birth; Bradycardia; Ventricular Premature Complexes
• Other Study ID Numbers: yl-yxb07-lcsyfa-201202; ChiCTR-TRC-12002504 (Other Identifier: ChiCTR)