The Effect of Metoprolol Succinate on the Cardiac Function of Patients With Thalassemia Cardiomyopathy a Double Blind Randomized Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- ejection fraction
研究概览
简要总结
effect of B blocker was first evaluated in patient with cardiomyopathy not induced by ischemia and idiopathic which as the most common causes of cardiomyopathy. Effect of BB on Thalassemia cardiomyopathy was evaluated in this study
详细描述
In this clinical trial, 45 patients with thalassemia cardiomyopathy were randomized to receive either metoprolol (n = 26) or placebo (n = 19). Echocardiography and 6 minute walk test was performed at baseline and repeated after 6 months and the values were compared.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •documented LVEF < 50% by echocardiography
- •B thalassemia
- •No decompensated heart failure for at least 4 weeks (hospitalization for CHF, worsening lower extremity edema, worsening dyspnea on exertion, , and orthopnea)
- •have no evidence of acute myocarditis and
- •hemoglobin level above 7 gr⁄dL.
排除标准
- •pulse rate below 60/min
- •systolic blood pressure less than 90 mmHg
- •evidence of peripheral vascular disease
- •major depression, history of asthma, PR interval more than 240 msec, second or third degree AV block
- •major medical diseases including diabetes mellitus requiring insulin injection, hypothyroidism, hypoparathyroidism, chronic renal failure (glomerular filtration rate below 30 ml/min), hepatic cirrhosis, hepatitis-B and hepatitis-C, positive tests for human immunodeficiency virus, and other hemoglobinopathies
研究组 & 干预措施
metoprolol
patient or intervention group
干预措施: metoprolol (Drug)
placebo group
control group
干预措施: placebo (Drug)
结局指标
主要结局
ejection fraction
时间窗: 6 months
LV contractility
endsystolic volume
时间窗: 6 months
functional capacity
6 minutes walk test
时间窗: 6 months
functional capacity
次要结局
- patient compliance(6 months)
研究者
Javad Kojuri
professor
Shiraz University of Medical Sciences