Shensong Yangxin Capsule in the Treatment of Heart Failure Complicated With Ventricular Premature Beat

January 7, 2013 updated by: Cong-xin Huang

Shensong Yangxin Capsule in the Treatment of Mild to Moderate Systolic Heart Failure Complicated With Ventricular Premature Beat: A Randomize, Double Blind, Placebo-controlled Multicenter Clinical Trial

The purpose of this study is to assess the effects of Chinese medicine Shensong Yangxin capsule for the chronic cardiac dysfunction complicated with ventricular premature beats.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Premature ventricular contractions is one of the most common arrhythmia in the patients with structural heart disease and heart failure, which is not only has the high incidence but also has a high predictive value of sudden death. The purpose of the study is to assess the effects of Chinese medicine Shensong Yangxin capsule for the chronic cardiac dysfunction complicated with ventricular premature beats, which based on the numbers of premature ventricular contractions in 24-hour ambulatory electrocardiogram (ECG) as the main endpoint of the study. Secondary endpoints are evaluation of the Shensong Yangxin capsule on cardiac function and quality of life. This study is a randomized, double-blind, placebo controlled, multi-center trial. Chronic heart failure patients(cardiac function is Class II-III) associated with premature ventricular contractions (premature number 720-10000 / 24h), who received standardized treatment for heart failure at least three months, were involved in the study. Patients were randomly assigned into Shensong Yangxin capsule group or placebo group, with the capsule administration of 4 granules t.i.d.for 12 weeks. 24-hour ambulatory ECG, echocardiography and evaluation of heart function were observed at baseline and 12 weeks after the intervention. The primary outcomes are the numbers of premature ventricular contractions in 24-hour ambulatory ECG, and the secondary outcomes are New York Heart Association (NYHA) classification, NT-proBNP, left ventricular ejection fraction (LVEF) and left ventricular end-diastolic dimension (LVEDD, 6 minute walking test and Minnesota living with heart failure questionnaire (MLHFQ).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
460

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Beijing Anzhen Hospital, Capital University of Medical Sciences
        • Contact:
          • changsheng Ma, PH D
          • Phone Number: 13901357404
      • Beijing, Beijing, China, 100000
        • Recruiting
        • China-Japan Freindship Hospital
        • Contact:
          • yong Wang, PH D
          • Phone Number: 13801239117
    • Chongqing
      • Chongqing, Chongqing, China, 404100
        • Recruiting
        • Chongqing Zhongshan Hospital
        • Contact:
          • xia Mei, PH D
          • Phone Number: 13508322668
    • Guangxi
      • Nanning, Guangxi, China, 530000
        • Recruiting
        • First Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
          • yue Xia, PH D
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • chunguang Qiu, PH D
          • Phone Number: 13803898806
    • Hubei
      • Enshi, Hubei, China, 445000
        • Recruiting
        • Enshi Autonomous Region Central Hospital
        • Contact:
          • yuanhong Li, PH D
          • Phone Number: 13986843863
      • Jingzhou, Hubei, China, 434000
        • Recruiting
        • Jingzhou Central Hospital
        • Contact:
          • xin Li, PH D
          • Phone Number: 13872347567
      • Shiyan, Hubei, China, 442000
        • Recruiting
        • General Hospital of Dongfeng Motor Corporation
        • Contact:
          • handong Yang, PH D
          • Phone Number: 13807285189
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Asia Heart Hospital
        • Contact:
          • yangyang Dai, PH D
          • Phone Number: 15327411241
      • Xiangyang, Hubei, China, 441000
        • Recruiting
        • Xiangyang Central Hospital
        • Contact:
          • wenwei Liu, PH D
          • Phone Number: 13907279669
      • Yichang, Hubei, China, 443000
        • Recruiting
        • The First College of Clinical Medical Science, China Three Gorges University
        • Contact:
          • jun Yang, PH D
          • Phone Number: 13972561866
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • First Hospital Affiliated to Nanjing Medical University
        • Contact:
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • The General Hospital Of Shenyang Military Region
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250000
        • Recruiting
        • Traffic hospitals of Shandong Province
        • Contact:
          • tian Wang, PH D
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai First People's Hospital
        • Contact:
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University
        • Contact:
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Zhongshan Hospital of Fudan University
        • Contact:
          • yunzeng Zou, PH D
          • Phone Number: 13817702933
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • Westchinahospital,Sichuanuniversity
        • Contact:
          • dejia Huang, PH D
          • Phone Number: 13908181686

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with cardiac function NYHA II~III, Left ventricular ejection fraction (LVEF) 35%~50% tested by Modified Simpson, has a stable hemodynamics and no need to deliver treatment through vein
  • To be treated by standard treatment of heart failure at least 3 months with a stable dosage already
  • Ventricular premature beats: 720-10000 beats/24 hours
  • Heart failure caused by ischemic heart disease, or dilated cardiomyopathy

Exclusion Criteria:

  • Subject to be expected to alive no more than 6 months
  • 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, atrioventricular conduction block (II degree of Type II or III degree), 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 abnormal sinus node function
  • The hypertension, diabetes difficult to be controlled

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Shensong Yangxin capsule
Shensong Yangxin capsule 4 granules t.i.d. po for 12weeks
Drug: Shensong Yangxin capsule
ShenSongYangXin Capsule 4 granules t.i.d. po for 12weeks
Placebo Comparator: placebo Capsule
placebo Capsule 4 granules t.i.d. po for 12weeks
Drug: placebo Capsule
4 granules t.i.d. po for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
numbers of the Premature ventricular contractions during 24-hour ambulatory ECG
Time Frame: 3 months
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
NYHA classification
Time Frame: 3 months
3 months
LVEF
Time Frame: 3 months
3 months
NT-proBNP
Time Frame: 3 months
3 months
Minnesota living with heart failure questionnaire (MLHFQ)
Time Frame: 3 months
3 months
6 minute walking test
Time Frame: 3 months
3 months
LVEDD
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cong-xin Huang

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fudan University
Third Military Medical University
Chinese Academy of Medical Sciences, Fuwai Hospital
Nanjing Medical University
Shanghai Changzheng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • yl-yxb06-lcsyfa-201201
  • 2012CB518600（2012CB518606） (Other Grant/Funding Number: National Basic Research Program of China（973 Program）)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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