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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 Wuhan University.
Recruitment status was:  Recruiting
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01612260
First received: May 24, 2012
Last updated: January 7, 2013
Last verified: January 2013
  Purpose
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.

Condition Intervention Phase
Heart Failure
Ventricular Premature Complex
Drug: Shensong Yangxin capsule
Drug: placebo Capsule
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Wuhan University:

Primary Outcome Measures:
  • numbers of the Premature ventricular contractions during 24-hour ambulatory ECG [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • NYHA classification [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • LVEF [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • NT-proBNP [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Minnesota living with heart failure questionnaire (MLHFQ) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • 6 minute walking test [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • LVEDD [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 460
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612260

Locations
China, Beijing
Beijing Anzhen Hospital, Capital University of Medical Sciences
Beijing, Beijing, China, 100000
China-Japan Freindship Hospital
Beijing, Beijing, China, 100000
China, Chongqing
Chongqing Zhongshan Hospital
Chongqing, Chongqing, China, 404100
China, Guangxi
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530000
China, Hebei
The first hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
China, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
China, Hubei
Enshi Autonomous Region Central Hospital
Enshi, Hubei, China, 445000
Jingzhou Central Hospital
Jingzhou, Hubei, China, 434000
General Hospital of Dongfeng Motor Corporation
Shiyan, Hubei, China, 442000
Wuhan Asia Heart Hospital
Wuhan, Hubei, China, 430022
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441000
The First College of Clinical Medical Science, China Three Gorges University
Yichang, Hubei, China, 443000
China, Jiangsu
First hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Nanjing Drum Tower Hospital,The Affiliated hospital of Nanjing University Medical school
Nanjing, Jiangsu, China, 210000
China, Liaoning
The General Hospital of Shenyang Military Region
Shenyang, Liaoning, China, 110000
China, Shandong
Traffic hospitals of Shandong Province
Jinan, Shandong, China, 250000
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University
Shanghai, Shanghai, China, 200000
Shanghai First People's Hospital
Shanghai, Shanghai, China, 200000
Zhongshan Hospital of Fudan University
Shanghai, Shanghai, China, 200000
China, Sichuan
Westchinahospital,Sichuanuniversity
Chengdu, Sichuan, China, 610000
Sponsors and Collaborators
Cong-xin Huang
Chinese Academy of Medical Sciences, Fuwai Hospital
Fudan University
Shanghai Changzheng Hospital
Nanjing Medical University
Third Military Medical University
  More Information

Responsible Party: Cong-xin Huang, professor, Wuhan University
ClinicalTrials.gov Identifier: NCT01612260     History of Changes
Other Study ID Numbers: yl-yxb06-lcsyfa-201201  2012CB518600(2012CB518606) 
Study First Received: May 24, 2012
Last Updated: January 7, 2013
Health Authority: China: Ethics Committee

Keywords provided by Wuhan University:
heart failure
ventricular premature complex
Shensong Yangxin capsule

Additional relevant MeSH terms:
Heart Failure
Premature Birth
Ventricular Premature Complexes
Cardiac Complexes, Premature
Heart Diseases
Cardiovascular Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on December 02, 2016