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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

Tracking Information
First Submitted Date  ICMJE December 6, 2012
First Posted Date  ICMJE December 17, 2012
Last Update Posted Date December 17, 2012
Study Start Date  ICMJE August 2012
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2012)
  • numbers of the Premature ventricular contractions detected by 24 houres ambulatory EKG [ Time Frame: 8 weeks ]
  • average heart rate detected by 24-hour ambulatory ECG [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2012)
  • numbers of the Premature ventricular contractions detected by 24-hour ambulatory ECG [ Time Frame: 4 weeks ]
  • average heart rate detected by 24-hour ambulatory ECG [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 13, 2012)
Minnesota living with heart failure questionnaire (MLHFQ) [ Time Frame: 8 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Shensongyangxin Capsule in the Treatment of Sinus Bradycardia With Premature Ventricular Contractions
Official Title  ICMJE Shensongyangxin Capsule in the Treatment of Sinus Bradycardia With Premature Ventricular Contractions Multi-center,Randomized, Double-blind, Placebo-controlled Clinical Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Premature Ventricular Contraction
Intervention  ICMJE
  • Drug: Shensong Yangxin capsule
    ShenSongYangXin 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
Study Arms  ICMJE
  • Experimental: Shensong Yangxin capsule
    Shensong Yangxin capsule 4 granules t.i.d. by mouth for 8weeks
    Intervention: Drug: Shensong Yangxin capsule
  • Placebo Comparator: placebo Capsule
    placebo Capsule 4 granules t.i.d. by mouth for 8 weeks
    Intervention: Drug: placebo Capsule
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 13, 2012)
330
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01750775
Other Study ID Numbers  ICMJE yl-yxb07-lcsyfa-201202
ChiCTR-TRC-12002504 ( Other Identifier: ChiCTR )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party kejiang Cao, The First Affiliated Hospital with Nanjing Medical University
Study Sponsor  ICMJE kejiang Cao
Collaborators  ICMJE
  • Chinese Academy of Medical Sciences, Fuwai Hospital
  • Third Military Medical University
Investigators  ICMJE
Principal Investigator: Kejiang Cao, M.D The First Affiliated Hospital with Nanjing Medical University
PRS Account The First Affiliated Hospital with Nanjing Medical University
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP