NCT00574756终止不适用
The Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in E/Ea
研究概览
简要总结
The purpose of this study is to evaluate the effects of ranolazine, an FDA-approved medication for the treatment of angina, on heart function by using echocardiography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate of severe diastolic dysfunction, E/Ea>12
- •Preserved systolic function
- •NYHA Class I-II
排除标准
- •QTc >450 msec at enrollment
- •Taking medications that prolong QT interval or are potent inhibitors of CYP3A
- •Significant coronary artery disease
- •Severe valvular disease
- •Hepatic disease
- •Severe kidney disease
- •Women of childbearing age
- •Prior serious ventricular arrhythmia
研究组 & 干预措施
1
Other
Active drug for 2 weeks, then washout period for 2 weeks, then placebo for 2 weeks
干预措施: ranolazine (Drug)
2
Other
Placebo for 2 weeks, then washout for 2 weeks, then ranolazine for 2 weeks
干预措施: ranolazine (Drug)
结局指标
主要结局
Change in E/Ea
时间窗: 2 weeks
次要结局
- changes in mitral inflow parameters (E, A, IVRT, DT)(2 weeks)
- Changes in pulmonary venous inflow (S, D, a reversal)(2 weeks)
- Changes in tissue doppler parameters (Ea, Aa)(2 weeks)
研究者
研究点 (1)
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