Clinical trial NCT01612260: Shensong Yangxin Capsule in the Treatment of Heart Failure Complicated With Ventricular Premature Beat
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart Failure
Ventricular Premature Complex
Keywords: heart failure
ventricular premature complex
Shensong Yangxin capsule
Lead sponsor: Wuhan University
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Fudan University
name: Shanghai Changzheng Hospital
name: Nanjing Medical University
name: Third Military Medical University
First posted: 2012-06-05
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: numbers of the Premature ventricular contractions during 24-hour ambulatory ECG
timeFrame: 3 months
Secondary outcomes:
measure: NYHA classification
timeFrame: 3 months
measure: LVEF
timeFrame: 3 months
measure: NT-proBNP
timeFrame: 3 months
measure: Minnesota living with heart failure questionnaire (MLHFQ)
timeFrame: 3 months
measure: 6 minute walking test
timeFrame: 3 months
measure: LVEDD
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital University of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: China-Japan Freindship Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Zhongshan Hospital
state: Chongqing
city: Nanning
country: China
facility: First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Shijiazhuang
country: China
facility: The first hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Enshi
country: China
facility: Enshi Autonomous Region Central Hospital
state: Hubei
city: Jingzhou
country: China
facility: Jingzhou Central Hospital
state: Hubei
city: Shiyan
country: China
facility: General Hospital of Dongfeng Motor Corporation
state: Hubei
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Yichang
country: China
facility: The First College of Clinical Medical Science, China Three Gorges University
state: Hubei
city: Nanjing
country: China
facility: First hospital Affiliated to Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital,The Affiliated hospital of Nanjing University Medical school
state: Jiangsu
city: Shenyang
country: China
facility: The General Hospital of Shenyang Military Region
state: Liaoning
city: Jinan
country: China
facility: Traffic hospitals of Shandong Province
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
state: Shanghai
city: Chengdu
country: China
facility: Westchinahospital,Sichuanuniversity
state: Sichuan
Study officials:
References:
citation: 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.