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

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ClinicalTrials.gov Identifier: NCT01750775
Recruitment Status : Unknown
Verified December 2012 by kejiang Cao, The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  Enrolling by invitation
First Posted : December 17, 2012
Last Update Posted : December 17, 2012
Sponsor:
Collaborators:
Chinese Academy of Medical Sciences, Fuwai Hospital
Third Military Medical University
Information provided by (Responsible Party):
kejiang Cao, The First Affiliated Hospital with Nanjing Medical University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Premature Ventricular Contraction Drug: Shensong Yangxin capsule Drug: placebo Capsule Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : August 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : December 2013
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. numbers of the Premature ventricular contractions detected by 24 houres ambulatory EKG [ Time Frame: 8 weeks ]
  2. average heart rate detected by 24-hour ambulatory ECG [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. numbers of the Premature ventricular contractions detected by 24-hour ambulatory ECG [ Time Frame: 4 weeks ]
  2. average heart rate detected by 24-hour ambulatory ECG [ Time Frame: 4 weeks ]

Other Outcome Measures:
  1. Minnesota living with heart failure questionnaire (MLHFQ) [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750775


Locations
China, Jiangsu
the First Affiliated Hospital of Nanjing Medical Universtiy
Nanjing, Jiangsu, China
Sponsors and Collaborators
kejiang Cao
Chinese Academy of Medical Sciences, Fuwai Hospital
Third Military Medical University
Investigators
Principal Investigator: Kejiang Cao, M.D The First Affiliated Hospital with Nanjing Medical University
More Information
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Additional Information:
the website of the first affiliated hospital with nanjing medical university  This link exits the ClinicalTrials.gov site

Responsible Party: kejiang Cao, director of cardiology cepartment, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01750775     History of Changes
Other Study ID Numbers: yl-yxb07-lcsyfa-201202
ChiCTR-TRC-12002504 ( Other Identifier: ChiCTR )
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012

Keywords provided by kejiang Cao, The First Affiliated Hospital with Nanjing Medical University:
sinus bradycardia
ventricular premature contraction

Additional relevant MeSH terms:
Premature Birth
Bradycardia
Ventricular Premature Complexes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
 Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Complexes, Premature