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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Cardiovascular Institute & Fuwai Hospital
Third Military Medical University
Information provided by (Responsible Party):
kejiang Cao, The First Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01750775
First received: December 6, 2012
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Premature Ventricular Contraction
Drug: Shensong Yangxin capsule
Drug: placebo Capsule
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Shensongyangxin Capsule in the Treatment of Sinus Bradycardia With Premature Ventricular Contractions Multi-center,Randomized, Double-blind, Placebo-controlled Clinical Study

Further study details as provided by The First Hospital of Nanjing Medical University:

Primary Outcome Measures:
  • numbers of the Premature ventricular contractions detected by 24 houres ambulatory EKG [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • average heart rate detected by 24-hour ambulatory ECG [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • numbers of the Premature ventricular contractions detected by 24-hour ambulatory ECG [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • average heart rate detected by 24-hour ambulatory ECG [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Minnesota living with heart failure questionnaire (MLHFQ) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Shensong Yangxin capsule
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
Other Name: 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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750775

Locations
China, Jiangsu
the First Affiliated Hospital of Nanjing Medical Universtiy
Nanjing, Jiangsu, China
Sponsors and Collaborators
kejiang Cao
Cardiovascular Institute & Fuwai Hospital
Third Military Medical University
Investigators
Principal Investigator: Kejiang Cao, M.D the First Affiliated Hospital of Nanjing Medical University
  More Information

Additional Information:
No publications provided

Responsible Party: kejiang Cao, director of cardiology cepartment, The First Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01750775     History of Changes
Other Study ID Numbers: yl-yxb07-lcsyfa-201202, ChiCTR-TRC-12002504
Study First Received: December 6, 2012
Last Updated: December 13, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by The First Hospital of Nanjing Medical University:
sinus bradycardia
ventricular premature contraction

Additional relevant MeSH terms:
Ventricular Premature Complexes
Bradycardia
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014