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

• ClinicalTrials.gov Identifier: NCT01750775
• Recruitment Status: Unknown
• First Posted: December 17, 2012
• Last Update Posted: December 17, 2012
• Sponsor: kejiang Cao
• 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

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

• 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

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

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

• 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

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:

the website of the first affiliated hospital with nanjing medical university 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: kejiang Cao, director of cardiology cepartment, The First Affiliated Hospital with Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT01750775
• Other Study ID Numbers: yl-yxb07-lcsyfa-201202; ChiCTR-TRC-12002504 ( Other Identifier: ChiCTR )
• First Posted: December 17, 2012
• 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; Cardiac Conduction System Disease