NCT02012075Unknown3 期
Efficacy and Safety Comparison of Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in Patients With Heart Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 316
- 试验地点
- 12
- 主要终点
- Change From Baseline in left ventricular ejection fraction(LVEF) by ultrasound cardiogram
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Extended-Release Carvedilol Sulfate
Experimental
18-72mg/d,po
干预措施: Extended-Release Carvedilol Sulfate (Drug)
Sustained-release Metoprolol Succinate
Active Comparator
11.875-190mg/d,po
干预措施: Sustained-release Metoprolol Succinate (Drug)
结局指标
主要结局
Change From Baseline in left ventricular ejection fraction(LVEF) by ultrasound cardiogram
时间窗: Baseline and Week 36
次要结局
- 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)
研究者
研究点 (12)
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