Multicentre, Open-label, Non-interventional Observational Clinical Study Lasting 48 Weeks in Patients With Heart Failure or Reduced Left Ventricular Ejection Fraction Following Acute Myocardial Infarction Who Are Treated With Carvedilol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 415
- 试验地点
- 1
- 主要终点
- Change in Left Ventricular Ejection Fraction LVEF(%)
研究概览
简要总结
Beta-blockers should be administered to all patients with heart failure stages II to IV NYHA. It should also be administered to patients with stage I after myocardial infarction. The low ejection fraction, especially after myocardial infarction is a strong indication for beta-blockers, as many studies indicate that administration of these drugs substantially reduces cardiovascular mortality. Beta-blockers reduce mortality and hospitalizations and improve the operational phase for all categories of patients with heart failure. Since beta-blockers, only carvedilol, metoprolol, and recently visoprololi nevimpololi have shown these benefits and thus, only those have to be administered.
The clinical study Carvedia aims to observe and record the action of beta-blocker carvedilol on cardiac function in patients with heart failure or reduced left ventricular ejection fraction after acute myocardial infarction.
详细描述
The relationship between stroke volume, which is extruded from the left ventricle gives a measure for the restrictive left ventricular function. Any patient with known cardiovascular disease should undergo assessment of left ventricular function by measuring the ejection fraction. Several studies have shown that when the ejection fraction (LVEF), which measures the heart's ability to eject blood to the aorta does not exceed 40% (natural price ^ 50%) increased dramatically in the post-infarction mortality. The ejection fraction as a reliable predictor, can be measured by ultrasonography. The reduced ejection fraction is associated with an increased risk of life-threatening arrhythmias, heart failure and death. The low ejection fraction, especially after myocardial infarction is a strong indication for beta-blockers, as many studies indicate that administration of these drugs substantially reduces cardiovascular mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients visiting outpatient clinics.
- •Male or female patients over 18 years
- •Patients with mild heart failure and history of symptoms according to the instructions of the European Society of Cardiology (ESC)
- •Patients who entered the study have LVEF <40% in echocardiography
- •Patients with new diagnosis of heart failure
- •Patients who have left ventricular ejection fraction after acute myocardial infarction <40%
- •Patients who have been treated in hospital during the previous month before their inclusion in the study
- •Patients who have signed the consent form for recording and processing of personal data.
- •Patients who are willing to comply with the requirements of the study
- •Patients who are treated with carvedilol for at least a month before their inclusion in this
排除标准
- •Patients under 18 years
- •Patients with unstable chronic heart failure
- •Patients with unstable hemodynamic profiles
- •Patients with heart valve disease
- •Patients with hypertrophic cardiomyopathy
- •Patients with unstable angina or active myocarditis
- •Patients with contraindications to treatment with beta-adrenergic receptors
- •Patients who have not consented to recording and processing of personal the data.
- •Women pregnant or breastfeeding
- •Patients have been treated in hospital during the preceding months before their inclusion in the study
- •Patients treated with carvedilol for less than one month
研究组 & 干预措施
Carvedilol, LVEF, Heart Failure
Patients with Heart Failure on carvedilol therapy measured for their LVEF value
干预措施: Carvedilol (Drug)
结局指标
主要结局
Change in Left Ventricular Ejection Fraction LVEF(%)
时间窗: 0 (baseline), 48 weeks (12 months)
Change from baseline in Left Ventricular Ejection Fraction LVEF(%) at 12 months.
次要结局
- Number of study participants with Adverse Events(0 (baseline), 24 weeks (6 months), 48 weeks (12 months))
- Cardedilol dosage range(0 (baseline), 24 weeks (6 months), 48 weeks)