Effects of Ranolazine on Myocardial Perfusion in Patients With Dilated Cardiomyopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Myocardial perfusion
研究概览
简要总结
Recent data suggest that areas of fibrosis and hibernating myocardium develop in patients with non ischemic dilated cardiomyopathy. Ranolazine is a new drug, developed to releave symptoms of angina in patients with stable coronary disease that is not suitable for surgical or percutaneous revascularization. It has been shown that in patients with stable coronary disease Ranolazine improves myocardial perfusion as shown with myocardial nuclear imaging. The aim of this trial is to evaluate effects of ranolazine on myocardial perfusion in patients with dilated cardiomyopathy.
详细描述
Recent data suggest that areas of fibrosis and hibernating myocardium develop in patients with non ischemic dilated cardiomyopathy. Ranolazine is a new drug, developed to releave symptoms of angina in patients with stable coronary disease that is not suitable for surgical or percutaneous revascularization. The main mechanism of action of Ranolazine is the inhibition of late I(Na) thus decreasing the Ca++ load in the cardiomyocites. Consequently oxygen consumption also decreases. It has also been shown that in patients with stable coronary disease Ranolazine improves myocardial perfusion as shown with myocardial nuclear imaging. The aim of this trial is to evaluate effects of ranolazine on myocardial perfusion in patients with dilated cardiomyopathy.
Primary end-point: To determine wheather Ranolazine improves perfusion of the myocardium in patients with non-ischemic dilated cardiomyopathy.
Secondary end-points: To determine wheather Ranolazine improves patients' NYHA functional class, excercise capacity, LV systolic and diastolic function and weather ranolazine affects supraventricular and ventricular arrhythmia occurance/frequency.
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
- Single (Outcomes Assessor)
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
- •established diagnosis of non-ischemic dilated cardiomyopathy
- •EF < 35%
- •NYHA f.c. II - IV
- •Optimal medical management > 6 months
- •Age < 75 years and > 18 years
排除标准
- •known hypersensitivity to the medication
- •age > 75 years or < 18 years
- •EF > 35%
- •renal insufficiency (GF < 30)
- •liver dysfunction (liver tests > 3x the upper normal limit))
- •LQT syndrome
- •drugs that affect CYP3A4 metabolism (azoles, macrolides, calcineurin inhibitors etc.)
- •active hemathological or malignant disease
研究组 & 干预措施
Ranolazine
Initial dose is 375 mg bid. After 2 - 4 weeks the dose is increased to 500 mg bid and after another 2-4 weeks to 750 mg bid. In case of side effects the dose of the drug is to be decreased to the highest dose that the patient is still able to tolerate.
干预措施: Ranolazine (Drug)
结局指标
主要结局
Myocardial perfusion
时间窗: 6 months
To determine wheather Ranolazine improves perfusion of the myocardium in patients with non-ischemic dilated cardiomyopathy assesed by myocardial nuclear imaging.
次要结局
- Excercise capacity(1, 3 and 6 months)
- Left ventricular systolic and diastolic function(1, 3 and 6 months)
- Supraventricular and ventricular arrhythmias(6 months)
研究者
Gregor Poglajen
MD, PhD
University Medical Centre Ljubljana