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Heart FailurePhase 4NCT01612260

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

A Phase 4 study testing Shensong Yangxin capsule in people with Heart Failure and Ventricular Premature Complex, run by Cong-xin Huang at 20 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Heart Failure, Ventricular Premature Complex
What is being tested?
Shensong Yangxin capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
460 participants
Where
20 sitesChina
Study dates
Sep 2012to Dec 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

20 sites in 1 country.

Cong-xin Huang, PH D contact

13907131546

huangcongxin@yahoo.com.cn

Xi Wang contact

15994207265

xiwangwhu@16..com

20 sites in 1 country

China20 sites, 20 recruiting

  • Beijing Anzhen Hospital, Capital University of Medical Sciences

    Beijing, Beijing Municipality, 100000

    changsheng Ma, PH D, 13901357404

    Recruiting

  • China-Japan Freindship Hospital

    Beijing, Beijing Municipality, 100000

    yong Wang, PH D, 13801239117

    Recruiting

  • Westchinahospital,Sichuanuniversity

    Chengdu, Sichuan, 610000

    dejia Huang, PH D, 13908181686

    Recruiting

  • Chongqing Zhongshan Hospital

    Chongqing, Chongqing Municipality, 404100

    xia Mei, PH D, 13508322668

    Recruiting

  • Enshi Autonomous Region Central Hospital

    Enshi, Hubei, 445000

    yuanhong Li, PH D, 13986843863

    Recruiting

  • Traffic hospitals of Shandong Province

    Jinan, Shandong, 250000

    tian Wang, PH D

    Recruiting

  • Jingzhou Central Hospital

    Jingzhou, Hubei, 434000

    xin Li, PH D, 13872347567

    Recruiting

  • First hospital Affiliated to Nanjing Medical University

    Nanjing, Jiangsu, 210000

    jiangang Zou, PH D, 13605191407, jgzou@njmu.edu.cn

    Recruiting

  • Nanjing Drum Tower Hospital,The Affiliated hospital of Nanjing University Medical school

    Nanjing, Jiangsu, 210000

    wei Xu, PH D, 13390900868, xuwei2003@medmail.com.cn

    Recruiting

  • First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530000

    weifeng Wu, PH D, 13907719960, wucna@yahoo.com.cn

    Recruiting

  • Ruijin Hospital, Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200000

    liqun Wu, PH D, 13801621534, wuliquan89@hotmail.com

    Recruiting

  • Shanghai First People's Hospital

    Shanghai, Shanghai Municipality, 200000

    fang Wang, PH D, 13621950918, onlyfang2@gmail.com

    Recruiting

  • Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200000

    yunzeng Zou, PH D, 13817702933

    Recruiting

  • The General Hospital of Shenyang Military Region

    Shenyang, Liaoning, 110000

    zulu Wang, PH D, 13309824590, wangzl@medmail.com.cn

    Recruiting

  • The first hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    yue Xia, PH D

    Recruiting

  • General Hospital of Dongfeng Motor Corporation

    Shiyan, Hubei, 442000

    handong Yang, PH D, 13807285189

    Recruiting

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei, 430022

    yangyang Dai, PH D, 15327411241

    Recruiting

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441000

    wenwei Liu, PH D, 13907279669

    Recruiting

  • The First College of Clinical Medical Science, China Three Gorges University

    Yichang, Hubei, 443000

    jun Yang, PH D, 13972561866

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

    chunguang Qiu, PH D, 13803898806

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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).

Being tested
Shensong Yangxin capsule, placebo Capsule
Keywords
heart failure, ventricular premature complex, Shensong Yangxin capsule
Medical subject headings
Heart Failure, Ventricular Premature Complexes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shensong Yangxin capsuleDrug

    ShenSongYangXin Capsule 4 granules t.i.d. po for 12weeks

  • placebo CapsuleDrug

    4 granules t.i.d. po for 12 weeks

Study groups in NCT01612260
Study groupRoleWhat they receive
Shensong Yangxin capsuleExperimentalShensong Yangxin capsule 4 granules t.i.d. po for 12weeks
Receives: Drug: Shensong Yangxin capsule
placebo CapsulePlacebo comparatorplacebo Capsule 4 granules t.i.d. po for 12weeks
Receives: Drug: placebo Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. numbers of the Premature ventricular contractions during 24-hour ambulatory ECG

    Measured: 3 months

Secondary outcomes (6)

  1. NYHA classification

    Measured: 3 months

  2. LVEF

    Measured: 3 months

  3. NT-proBNP

    Measured: 3 months

  4. Minnesota living with heart failure questionnaire (MLHFQ)

    Measured: 3 months

  5. 6 minute walking test

    Measured: 3 months

  6. LVEDD

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionAug 2013 (estimated)
  4. Study completionDec 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
460 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01612260
Sponsor's protocol ID
yl-yxb06-lcsyfa-201201
Other IDs
2012CB518600（2012CB518606）
Status last verified
Jan 2013
First submitted
24 May 2012
Last updated
8 Jan 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Wang X, Hu D, Dang S, Huang H, Huang CX, Yuan MJ, Tang YH, Zheng QS, Yin F, Zhang S, Zhang BL, Gao RL; Efficacy and Safety of Shensong Yangxin Capsules for Frequent VPCs in Congestive Heart Failure Study Group. Effects of Traditional Chinese Medicine Shensong Yangxin Capsules on Heart Rhythm and Function in Congestive Heart Failure Patients with Frequent Ventricular Premature Complexes: A Randomized, Double-blind, Multicenter Clinical Trial. Chin Med J (Engl). 2017 Jul 20;130(14):1639-1647. doi: 10.4103/0366-6999.209906.

    PubMed 28685712

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Shensong Yangxin capsule in people with Heart Failure and Ventricular Premature Complex, run by Cong-xin Huang at 20 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cong-xin Huang, PH D (13907131546, huangcongxin@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

numbers of the Premature ventricular contractions during 24-hour ambulatory ECG (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01612260, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2013.

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