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Shensongyangxin Capsule in the Treatment of Sinus Bradycardia With Premature Ventricular Contractions

NCT ID: NCT01750775

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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).

Conditions

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Premature Ventricular Contraction

Keywords

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sinus bradycardia ventricular premature contraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Shensong Yangxin capsule

Shensong Yangxin capsule 4 granules t.i.d. by mouth for 8weeks

Group Type EXPERIMENTAL

Shensong Yangxin capsule

Intervention Type DRUG

ShenSongYangXin Capsule 4 granules t.i.d. by mouth for 8 weeks

placebo Capsule

placebo Capsule 4 granules t.i.d. by mouth for 8 weeks

Group Type PLACEBO_COMPARATOR

placebo Capsule

Intervention Type DRUG

placebo Capsule 4 granules t.i.d. by mouth for 8 weeks

Interventions

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Shensong Yangxin capsule

ShenSongYangXin Capsule 4 granules t.i.d. by mouth for 8 weeks

Intervention Type DRUG

placebo Capsule

placebo Capsule 4 granules t.i.d. by mouth for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role collaborator

Third Military Medical University

OTHER

Sponsor Role collaborator

kejiang Cao

OTHER

Sponsor Role lead

Responsible Party

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kejiang Cao

director of cardiology cepartment

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kejiang Cao, M.D

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

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the First Affiliated Hospital of Nanjing Medical Universtiy

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 30949218 (View on PubMed)

Other Identifiers

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ChiCTR-TRC-12002504

Identifier Type: OTHER

Identifier Source: secondary_id

yl-yxb07-lcsyfa-201202

Identifier Type: -

Identifier Source: org_study_id