Shensongyangxin Capsule in the Treatment of Sinus Bradycardia With Premature Ventricular Contractions (SS-SBVPT)
This study is enrolling participants by invitation only.
Sponsor:
kejiang Cao
Collaborators:
Chinese Academy of Medical Sciences, 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
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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 Affiliated Hospital with 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
|
|
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
|
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 (Adult, Senior) |
| 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
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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
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
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
Additional Information:
| 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 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 |
ClinicalTrials.gov processed this record on September 23, 2016