Shensong Yangxin Capsule in the Treatment of Heart Failure Complicated With Ventricular Premature Beat
2 other identifiers
interventional
460
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 heart-failure
Started Sep 2012
Shorter than P25 for phase_4 heart-failure
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2012
CompletedFirst Posted
Study publicly available on registry
June 5, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 8, 2013
January 1, 2013
11 months
May 24, 2012
January 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
numbers of the Premature ventricular contractions during 24-hour ambulatory ECG
3 months
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Shensong Yangxin capsule
EXPERIMENTALShensong Yangxin capsule 4 granules t.i.d. po for 12weeks
placebo Capsule
PLACEBO COMPARATORplacebo Capsule 4 granules t.i.d. po for 12weeks
Interventions
ShenSongYangXin Capsule 4 granules t.i.d. po for 12weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cong-xin Huanglead
- Chinese Academy of Medical Sciences, Fuwai Hospitalcollaborator
- Fudan Universitycollaborator
- Shanghai Changzheng Hospitalcollaborator
- Nanjing Medical Universitycollaborator
- Third Military Medical Universitycollaborator
Study Sites (20)
Beijing Anzhen Hospital, Capital University of Medical Sciences
Beijing, Beijing Municipality, 100000, China
China-Japan Freindship Hospital
Beijing, Beijing Municipality, 100000, China
Chongqing Zhongshan Hospital
Chongqing, Chongqing Municipality, 404100, China
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530000, China
The first hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Enshi Autonomous Region Central Hospital
Enshi, Hubei, 445000, China
Jingzhou Central Hospital
Jingzhou, Hubei, 434000, China
General Hospital of Dongfeng Motor Corporation
Shiyan, Hubei, 442000, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441000, China
The First College of Clinical Medical Science, China Three Gorges University
Yichang, Hubei, 443000, China
First hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, 210000, China
Nanjing Drum Tower Hospital,The Affiliated hospital of Nanjing University Medical school
Nanjing, Jiangsu, 210000, China
The General Hospital of Shenyang Military Region
Shenyang, Liaoning, 110000, China
Traffic hospitals of Shandong Province
Jinan, Shandong, 250000, China
Ruijin Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200000, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200000, China
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200000, China
Westchinahospital,Sichuanuniversity
Chengdu, Sichuan, 610000, China
Related Publications (1)
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.
PMID: 28685712DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
May 24, 2012
First Posted
June 5, 2012
Study Start
September 1, 2012
Primary Completion
August 1, 2013
Study Completion
December 1, 2013
Last Updated
January 8, 2013
Record last verified: 2013-01