A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Heart Failure
Efficacy and Safety Comparison of Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in Patients With Heart Failure
1 other identifier
interventional
316
1 country
12
Brief Summary
The aim of present study is to evaluate the efficacy and safety of Extended-Release Carvedilol Sulfate versus Sustained-release Metoprolol Succinate in Patients With Mild or Moderate Chronic Heart Failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 heart-failure
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 10, 2013
CompletedFirst Posted
Study publicly available on registry
December 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedDecember 16, 2013
December 1, 2013
1.2 years
December 10, 2013
December 10, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in left ventricular ejection fraction(LVEF) by ultrasound cardiogram
Baseline and Week 36
Secondary Outcomes (6)
Change From Baseline in Left Ventricular End Systolic Volume Index
Baseline and Week 36
Change From Baseline in Left Ventricular End Diastolic Volume Index
Baseline and Week 36
Incidence of Hospitalizations From Exacerbation of Heart Failure
Baseline and Week 36
Incidence of Hospitalizations From All Causes
Baseline and Week 36
Incidence of Deaths From All Causes
Baseline and Week 36
- +1 more secondary outcomes
Study Arms (2)
Extended-Release Carvedilol Sulfate
EXPERIMENTAL18-72mg/d,po
Sustained-release Metoprolol Succinate
ACTIVE COMPARATOR11.875-190mg/d,po
Interventions
Eligibility Criteria
You may qualify if:
- Males or Females
- Aged from 18 to 75 years
- New York Heart Association(NYHA) classification Ⅱ-Ⅲ
- At screening, subject has an LVEF\<0.45
- Have received optimal therapy with an Angiotensin converting enzyme inhibitors or angiotensin receptor blocker for 4 weeks before enrollment
- Subjects with symptoms of Stable heart failure do not need intravenous injection diuretics,cardiac inotropes or vasodilators
- Willing to provide written informed consent
You may not qualify if:
- Current treatment on any Class I or III antiarrhythmic, except amiodarone or beta-blockers
- Current treatment on calcium antagonists except for long-acting dihydropyridine agents
- Have a history of acute coronary syndrome,cerebral apoplexy or transient ischemic attack with 3 months
- Have a history of cardio-vascular surgery or other vessel operations with 3 months
- Have a history of sustained ventricular tachycardia or ventricular fibrillation with 3 months
- Have a plan to receive coronary revascularization or heart transplantation
- Uncontrolled ventricular arrhythmias (not controlled with antiarrhythmic therapy or an implantable defibrillator)
- Subjects with uncorrected primary obstructive or severe regurgitative valvular disease，nondilated (restrictive) or hypertrophic cardiomyopathy
- Sitting systolic blood pressure≤90mmHg (based on an average of 3 readings)
- Current decompensated heart failure
- Second or third degree heart block，or sick sinus syndrome，a pacemaker is not placed
- Contraindication to vasodilators
- Have a history of cardiac resynchronization therapy or
- Have received cardioverter defibrillator or pacemaker with 1 month
- Resting heart rate\<50 beats per minute(based on the average of 3 readings)
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Gansu Provincial Hospital
Lanzhou, Gansu, China
Tongji Hospital
Wuhan, Hubei, 430030, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Taizhou Hospital
Taizhou, Zhejiang, China
Beijing ANZHEN Hospital
Beijing, 100029, China
China-Japan Friendship Hospital
Beijing, 100029, China
Xuan Wu Hospital affiliated to Capital Medical University
Beijing, 100053, China
Beijing Tongren hospital affiliated to Capital Medical University
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Changsheng Ma, Professor
Beijing Anzhen Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2013
First Posted
December 16, 2013
Study Start
December 1, 2013
Primary Completion
February 1, 2015
Last Updated
December 16, 2013
Record last verified: 2013-12