Shensong Yangxin Capsule in the Treatment of Heart Failure Complicated With Ventricular Premature Beat
- Conditions
- Heart FailureVentricular Premature Complex
- Interventions
- Drug: placebo CapsuleDrug: Shensong Yangxin capsule
- Registration Number
- NCT01612260
- Lead Sponsor
- Cong-xin Huang
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 460
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Capsule placebo Capsule placebo Capsule 4 granules t.i.d. po for 12weeks Shensong Yangxin capsule Shensong Yangxin capsule Shensong Yangxin capsule 4 granules t.i.d. po for 12weeks
- Primary Outcome Measures
Name Time Method numbers of the Premature ventricular contractions during 24-hour ambulatory ECG 3 months
- Secondary Outcome Measures
Name Time Method NYHA classification 3 months LVEF 3 months NT-proBNP 3 months Minnesota living with heart failure questionnaire (MLHFQ) 3 months 6 minute walking test 3 months LVEDD 3 months
Trial Locations
- Locations (20)
The first hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
General Hospital of Dongfeng Motor Corporation
🇨🇳Shiyan, Hubei, China
First hospital Affiliated to Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Ruijin Hospital, Shanghai Jiaotong University
🇨🇳Shanghai, Shanghai, China
Beijing Anzhen Hospital, Capital University of Medical Sciences
🇨🇳Beijing, Beijing, China
China-Japan Freindship Hospital
🇨🇳Beijing, Beijing, China
Chongqing Zhongshan Hospital
🇨🇳Chongqing, Chongqing, China
First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Enshi Autonomous Region Central Hospital
🇨🇳Enshi, Hubei, China
Jingzhou Central Hospital
🇨🇳Jingzhou, Hubei, China
Wuhan Asia Heart Hospital
🇨🇳Wuhan, Hubei, China
The First College of Clinical Medical Science, China Three Gorges University
🇨🇳Yichang, Hubei, China
Xiangyang Central Hospital
🇨🇳Xiangyang, Hubei, China
Traffic hospitals of Shandong Province
🇨🇳Jinan, Shandong, China
Nanjing Drum Tower Hospital,The Affiliated hospital of Nanjing University Medical school
🇨🇳Nanjing, Jiangsu, China
Zhongshan Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
The General Hospital of Shenyang Military Region
🇨🇳Shenyang, Liaoning, China
Shanghai First People's Hospital
🇨🇳Shanghai, Shanghai, China
Westchinahospital,Sichuanuniversity
🇨🇳Chengdu, Sichuan, China