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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Cong-xin Huang, Wuhan University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01612260
First Posted: June 5, 2012
Last Update Posted: January 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Chinese Academy of Medical Sciences, Fuwai Hospital
Fudan University
Shanghai Changzheng Hospital
Nanjing Medical University
Third Military Medical University
Information provided by (Responsible Party):
Cong-xin Huang, Wuhan University
May 24, 2012
June 5, 2012
January 8, 2013
September 2012
August 2013   (Final data collection date for primary outcome measure)
numbers of the Premature ventricular contractions during 24-hour ambulatory ECG [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT01612260 on ClinicalTrials.gov Archive Site
  • NYHA classification [ Time Frame: 3 months ]
  • LVEF [ Time Frame: 3 months ]
  • NT-proBNP [ Time Frame: 3 months ]
  • Minnesota living with heart failure questionnaire (MLHFQ) [ Time Frame: 3 months ]
  • 6 minute walking test [ Time Frame: 3 months ]
  • LVEDD [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
 
Shensong Yangxin Capsule in the Treatment of Heart Failure Complicated With Ventricular Premature Beat
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.
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).
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Heart Failure
  • Ventricular Premature Complex
  • Drug: Shensong Yangxin capsule
    ShenSongYangXin Capsule 4 granules t.i.d. po for 12weeks
  • Drug: placebo Capsule
    4 granules t.i.d. po for 12 weeks
  • Experimental: Shensong Yangxin capsule
    Shensong Yangxin capsule 4 granules t.i.d. po for 12weeks
    Intervention: Drug: Shensong Yangxin capsule
  • Placebo Comparator: placebo Capsule
    placebo Capsule 4 granules t.i.d. po for 12weeks
    Intervention: Drug: placebo Capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
460
December 2013
August 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01612260
yl-yxb06-lcsyfa-201201
2012CB518600(2012CB518606) ( Other Grant/Funding Number: National Basic Research Program of China(973 Program) )
Yes
Not Provided
Not Provided
Cong-xin Huang, Wuhan University
Cong-xin Huang
  • Chinese Academy of Medical Sciences, Fuwai Hospital
  • Fudan University
  • Shanghai Changzheng Hospital
  • Nanjing Medical University
  • Third Military Medical University
Not Provided
Wuhan University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP