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| ID | Type | Description | Link |
|---|---|---|---|
| 2012CB518600(2012CB518606) | Other Grant/Funding Number | National Basic Research Program of China(973 Program) |
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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| Fudan University | OTHER |
| Shanghai Changzheng Hospital | OTHER |
| Nanjing Medical University |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shensong Yangxin capsule | Experimental | Shensong Yangxin capsule 4 granules t.i.d. po for 12weeks |
|
| placebo Capsule | Placebo Comparator | placebo Capsule 4 granules t.i.d. po for 12weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shensong Yangxin capsule | Drug | ShenSongYangXin Capsule 4 granules t.i.d. po for 12weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| numbers of the Premature ventricular contractions during 24-hour ambulatory ECG | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| NYHA classification | 3 months | |
| LVEF | 3 months | |
| NT-proBNP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cong-xin Huang, PH D | Contact | 13907131546 | huangcongxin@yahoo.com.cn | |
| Xi Wang | Contact | 15994207265 | xiwangwhu@16..com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital University of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28685712 | Derived | 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. |
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| OTHER |
| Third Military Medical University | OTHER |
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| placebo Capsule | Drug | 4 granules t.i.d. po for 12 weeks |
|
| 3 months |
| Minnesota living with heart failure questionnaire (MLHFQ) | 3 months |
| 6 minute walking test | 3 months |
| LVEDD | 3 months |
| China-Japan Freindship Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| Chongqing Zhongshan Hospital | Recruiting | Chongqing | Chongqing Municipality | 404100 | China |
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| First Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | 530000 | China |
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| The first hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050000 | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450000 | China |
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| Enshi Autonomous Region Central Hospital | Recruiting | Enshi | Hubei | 445000 | China |
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| Jingzhou Central Hospital | Recruiting | Jingzhou | Hubei | 434000 | China |
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| General Hospital of Dongfeng Motor Corporation | Recruiting | Shiyan | Hubei | 442000 | China |
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| Wuhan Asia Heart Hospital | Recruiting | Wuhan | Hubei | 430022 | China |
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| Xiangyang Central Hospital | Recruiting | Xiangyang | Hubei | 441000 | China |
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| The First College of Clinical Medical Science, China Three Gorges University | Recruiting | Yichang | Hubei | 443000 | China |
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| First hospital Affiliated to Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| Nanjing Drum Tower Hospital,The Affiliated hospital of Nanjing University Medical school | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| The General Hospital of Shenyang Military Region | Recruiting | Shenyang | Liaoning | 110000 | China |
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| Traffic hospitals of Shandong Province | Recruiting | Jinan | Shandong | 250000 | China |
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| Ruijin Hospital, Shanghai Jiaotong University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| Shanghai First People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| Zhongshan Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| Westchinahospital,Sichuanuniversity | Recruiting | Chengdu | Sichuan | 610000 | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D018879 | Ventricular Premature Complexes |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D005117 | Cardiac Complexes, Premature |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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