NCT01750775

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

1.1 years

First QC Date

December 6, 2012

Last Update Submit

December 13, 2012

Conditions

Premature Ventricular Contraction

Keywords

sinus bradycardiaventricular premature contraction

Outcome Measures

Primary Outcomes (2)

  • numbers of the Premature ventricular contractions detected by 24 houres ambulatory EKG

    8 weeks

  • average heart rate detected by 24-hour ambulatory ECG

    8 weeks

Secondary Outcomes (2)

  • numbers of the Premature ventricular contractions detected by 24-hour ambulatory ECG

    4 weeks

  • average heart rate detected by 24-hour ambulatory ECG

    4 weeks

Other Outcomes (1)

  • Minnesota living with heart failure questionnaire (MLHFQ)

    8 weeks

Study Arms (2)

Shensong Yangxin capsule

EXPERIMENTAL

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

Drug: Shensong Yangxin capsule

placebo Capsule

PLACEBO COMPARATOR

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

Drug: placebo Capsule

Interventions

Shensong Yangxin capsuleDRUG

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

Shensong Yangxin capsule
placebo CapsuleDRUG

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

placebo Capsule

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical Universtiy

Nanjing, Jiangsu, China

Location

Related Publications (1)

  • 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.

    PMID: 30949218DERIVED

MeSH Terms

Conditions

Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Cardiac Complexes, PrematureArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kejiang Cao, M.D

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
director of cardiology cepartment

Study Record Dates

First Submitted

December 6, 2012

First Posted

December 17, 2012

Study Start

August 1, 2012

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations

CN(1)