Shensong Yangxin Capsule in the Treatment of Heart Failure Complicated With Ventricular Premature Beat
This study is currently recruiting participants.
Verified January 2013 by Wuhan University
Sponsor:
Cong-xin Huang
Collaborators:
Cardiovascular Institute & 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
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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
Other Name: Shensong Yangxin capsule
|
|
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
Other Name: placebo Capsule
|
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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612260
Contacts
| Contact: Cong-xin Huang, PH D | 13907131546 | huangcongxin@yahoo.com.cn |
| Contact: Xi Wang | 15994207265 | xiwangwhu@16..com |
Locations
| China, Beijing | |
| China-Japan Freindship Hospital | Recruiting |
| Beijing, Beijing, China, 100000 | |
| Contact: yong Wang, PH D 13801239117 | |
| Beijing Anzhen Hospital, Capital University of Medical Sciences | Recruiting |
| Beijing, Beijing, China, 100000 | |
| Contact: changsheng Ma, PH D 13901357404 | |
| China, Chongqing | |
| Chongqing Zhongshan Hospital | Recruiting |
| Chongqing, Chongqing, China, 404100 | |
| Contact: xia Mei, PH D 13508322668 | |
| China, Guangxi | |
| First Affiliated Hospital of Guangxi Medical University | Recruiting |
| Nanning, Guangxi, China, 530000 | |
| Contact: weifeng Wu, PH D 13907719960 wucna@yahoo.com.cn | |
| China, Hebei | |
| The first hospital of Hebei Medical University | Recruiting |
| Shijiazhuang, Hebei, China, 050000 | |
| Contact: yue Xia, PH D | |
| China, Henan | |
| The First Affiliated Hospital of Zhengzhou University | Recruiting |
| Zhengzhou, Henan, China, 450000 | |
| Contact: chunguang Qiu, PH D 13803898806 | |
| China, Hubei | |
| Enshi Autonomous Region Central Hospital | Recruiting |
| Enshi, Hubei, China, 445000 | |
| Contact: yuanhong Li, PH D 13986843863 | |
| Jingzhou Central Hospital | Recruiting |
| Jingzhou, Hubei, China, 434000 | |
| Contact: xin Li, PH D 13872347567 | |
| General Hospital of Dongfeng Motor Corporation | Recruiting |
| Shiyan, Hubei, China, 442000 | |
| Contact: handong Yang, PH D 13807285189 | |
| Wuhan Asia Heart Hospital | Recruiting |
| Wuhan, Hubei, China, 430022 | |
| Contact: yangyang Dai, PH D 15327411241 | |
| Xiangyang Central Hospital | Recruiting |
| Xiangyang, Hubei, China, 441000 | |
| Contact: wenwei Liu, PH D 13907279669 | |
| The First College of Clinical Medical Science, China Three Gorges University | Recruiting |
| Yichang, Hubei, China, 443000 | |
| Contact: jun Yang, PH D 13972561866 | |
| China, Jiangsu | |
| First hospital Affiliated to Nanjing Medical University | Recruiting |
| Nanjing, Jiangsu, China, 210000 | |
| Contact: jiangang Zou, PH D 13605191407 jgzou@njmu.edu.cn | |
| Nanjing Drum Tower Hospital,The Affiliated hospital of Nanjing University Medical school | Recruiting |
| Nanjing, Jiangsu, China, 210000 | |
| Contact: wei Xu, PH D 13390900868 xuwei2003@medmail.com.cn | |
| China, Liaoning | |
| The General Hospital of Shenyang Military Region | Recruiting |
| Shenyang, Liaoning, China, 110000 | |
| Contact: zulu Wang, PH D 13309824590 wangzl@medmail.com.cn | |
| China, Shandong | |
| Traffic hospitals of Shandong Province | Recruiting |
| Jinan, Shandong, China, 250000 | |
| Contact: tian Wang, PH D | |
| China, Shanghai | |
| Zhongshan Hospital of Fudan University | Recruiting |
| Shanghai, Shanghai, China, 200000 | |
| Contact: yunzeng Zou, PH D 13817702933 | |
| Shanghai First People's Hospital | Recruiting |
| Shanghai, Shanghai, China, 200000 | |
| Contact: fang Wang, PH D 13621950918 onlyfang2@gmail.com | |
| Ruijin Hospital, Shanghai Jiaotong University | Recruiting |
| Shanghai, Shanghai, China, 200000 | |
| Contact: liqun Wu, PH D 13801621534 wuliquan89@hotmail.com | |
| China, Sichuan | |
| Westchinahospital,Sichuanuniversity | Recruiting |
| Chengdu, Sichuan, China, 610000 | |
| Contact: dejia Huang, PH D 13908181686 | |
Sponsors and Collaborators
Cong-xin Huang
Cardiovascular Institute & Fuwai Hospital
Fudan University
Shanghai Changzheng Hospital
Nanjing Medical University
Third Military Medical University
More Information
No publications provided
| 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 Ventricular Premature Complexes Cardiac Complexes, Premature Heart Failure, Systolic |
Heart Diseases Cardiovascular Diseases Arrhythmias, Cardiac Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013