NCT01979965Unknown4 期
Ranolazine Effects on Ischemic Mitral Regurgitation Severity in Patients With Cardiac Resynchronization Therapy
University Cardiology1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- effective regurgitant orifice by echocardiography
研究概览
简要总结
The purpose of this study is to find out whether mitral regurgitation (or a leaky heart valve) caused by ischemic heart disease (decreased blood flow to heart muscle) will improve after administration of ranolazine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Ischemic cardiomyopathy AND
- •Moderate or severe mitral regurgitation AND
- •Cardiac resynchronization therapy (CRT) ≥ 3 months prior to enrollment AND
- •Maximal Medical Therapy (ACE-Inhibitor, beta blocker, aldosterone antagonist, diuretic, aspirin, statin)
排除标准
- •nonischemic cardiomyopathy
- •active heart failure
- •current ranolazine therapy
- •congenital heart disease
- •mechanical valve prostheses
- •vegetation/endocarditis
- •significant pulmonary disease
- •peripheral vascular disease
- •trivial or mild mitral regurgitation
- •creatinine clearance < 30 mL/min
- •liver cirrhosis
- •strong inhibitors of CYP3A (including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir)
- •strong inducers of CYP3A (including rifampin, rifapentine, phenobarbital, phenytoin, carbamazepine and St.John's wort)
- •Strong P-glycoprotein inhibitors (including cyclosporine, verapamil, and quinidine)
- •Initial QTc interval ≥ 440msec
研究组 & 干预措施
Active drug
Active Comparator
Ranolazine therapy for three months
干预措施: Ranolazine (Active drug) (Drug)
Sugar Pill
Placebo Comparator
sugar pill therapy for three months
干预措施: Placebo (Drug)
结局指标
主要结局
effective regurgitant orifice by echocardiography
时间窗: Day T = 90 days
proximal isovelocity surface area by echocardiography
时间窗: T = 90 days
次要结局
- Seattle Angina Questionnaire(T = 0 days, and T = 90 days)
- Rose Dyspnea Scale(T = 0 days, and T= 90 days)
研究者
研究点 (1)
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