临床试验/NCT01728025

NCT01728025Unknown2 期

Long Term Prophylactic Therapy of Congenital Long QT Syndrome Type III (LQT3) With Ranolazine

Tel-Aviv Sourasky Medical Center1 个研究点分布在 1 个国家目标入组 10 人开始时间: 2012年10月最近更新: 2015年3月26日

适应症

干预措施

试验速览

阶段: 2 期
发起方: Tel-Aviv Sourasky Medical Center
入组人数: 10
试验地点: 1
主要终点: Number of participants with syncope and/or documented ventricular arrhythmia

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether ranolazine will reduce the risk of arrhythmic events in patients with long QT syndrome type 3.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Long QT patients with genetic confirmation of carrier-status for the D1790G mutation in the SCN5A gene
•Corrected QT interval > 460 msec

排除标准

•Need for therapy with medications that are potent or moderately potent CYP3A inhibitors (such as ketoconazole, diltiazem, verapamil, macrolide antibiotics or HIV protease inhibitors)

研究组 & 干预措施

Ranolazine

Experimental

Ranolazine 500-1000 mg twice a day as tolerated

干预措施: Ranolazine (Drug)

结局指标

主要结局

Number of participants with syncope and/or documented ventricular arrhythmia

时间窗: 5 years

次要结局

Change in corrected QT interval(within 30 days of initiation of Ranolazine treatment)

研究者

发起方

Tel-Aviv Sourasky Medical Center

申办方类型

Other Gov

责任方

Sponsor

研究点 (1)

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