A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Heart Failure
Phase 3
- Conditions
- Heart Failure
- Interventions
- Registration Number
- NCT02012075
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 316
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
- Elevated liver enzymes (alanine aminotransferase or aspartate aminotransferase levels greater than 3 times upper limit of normal)
- Serum creatinine levels greater than 2 times upper limit of normal
- Current clinical evidence of obstructive pulmonary disease (e.g., asthma or bronchitis) requiring inhaled or oral bronchodilator or steroid therapy
- History of drug sensitivity or allergic reaction to alpha or beta-blockers
- Contraindication or intolerance to beta-blockers
- Pregnant or lactating women and women planning to become pregnant
- Has any systemic disease, including cancer, with reduced life expectancy (<12 months)
- Use of an investigational drug within 30 days of enrollment
- Participation in an investigational device trial within 30 days of enrollment
- Known drug or alcohol abuse 1 year prior to enrollment
- Has a history of psychological illness/condition that interferes with ability to understand or complete requirements of the study
- In the opinion of the investigator the subject is known to be noncompliant with prescribed medication regimen
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sustained-release Metoprolol Succinate Sustained-release Metoprolol Succinate 11.875-190mg/d,po Extended-Release Carvedilol Sulfate Extended-Release Carvedilol Sulfate 18-72mg/d,po
- Primary Outcome Measures
Name Time Method Change From Baseline in left ventricular ejection fraction(LVEF) by ultrasound cardiogram Baseline and Week 36
- Secondary Outcome Measures
Name Time Method Incidence of Deaths From All Causes Baseline and Week 36 Change From Baseline in New York Heart Association（NYHA）classification Baseline and Week 36 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
Trial Locations
- Locations (12)
Gansu Provincial Hospital
🇨🇳Lanzhou, Gansu, China
Tongji Hospital
🇨🇳Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Northern Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
Taizhou Hospital
🇨🇳Taizhou, Zhejiang, China
Beijing ANZHEN Hospital
🇨🇳Beijing, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
China-Japan Friendship Hospital
🇨🇳Beijing, China
Beijing Tongren hospital affiliated to Capital Medical University
🇨🇳Beijing, China
Xuan Wu Hospital affiliated to Capital Medical University
🇨🇳Beijing, China