Reduction of Symptomatic Ventricular Premature Beats With Ranolazine
试验速览
- 阶段
- 4 期
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Reduction in Premature Ventricular Beats
研究概览
简要总结
Investigate whether ranolazine, a novel anti-anginal agent with antiarrhythmic properties, has a role in the management of symptomatic ventricular premature beats.
详细描述
The main objective is to compare the effect of ranolazine versus placebo on premature ventricular beats (using 24-hour ambulatory electrocardiographic monitoring) for subjects with symptomatic palpitations. Subject population will consist of seventy-two adult subjects of both sexes who have greater than 1,000 premature ventricular beats during initial monitoring.
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
- Triple (Participant, Care Provider, 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
- •Subjects male and female 18 years and older
- •Symptoms of palpitations
- •Greater than or equal to 1,000 Ventricular Premature Beats during 24-hour electrocardiographic monitoring
- •Completion of a consent form prior to pre-randomization Holter monitor
排除标准
- •Moderate to severe symptomatic heart failure, New York Heart Association Class III/IV
- •Moderate to severe symptomatic angina, Canadian Cardiovascular Classification III/IV
- •Moderate to severe structural heart disease in the absence of an implantable cardiac defibrillator in a subject who would otherwise be eligible for a defibrillator (e.g. history of myocardial infarction and a left ventricular ejection fraction less than 30%)
- •Clinically significant hepatic disease (cirrhosis or chronic hepatitis) or abnormal liver associated enzymes greater than three times the upper limits of normal
- •A baseline corrected QT interval greater than or equal to 500msec or history of congenital channelopathy (long QT syndrome, Brugada syndrome) or torsades de pointes.
- •Treatment with agents known to prolong the QTc interval
- •Treatment with agents that are potent or moderately potent inhibitors of CYP3A, to include, but is not limited to the following: ketoconazole, HIV protease inhibitors (i.e. ritonavir), macrolide antibiotics (i.e. clarithromycin), diltiazem and verapamil
- •Females who are pregnant, planning to get pregnant, or breast feeding ( females under the age of 55 years who have not previously undergone surgical sterilization procedures will have serum qualitative pregnancy testing)
- •Thyroid stimulating hormone less than 0.27 IU/mL
- •Serum magnesium less than 1.5mg/dL
- •Serum potassium less than 3.5 mEq/dL or greater than 5.0 mEq/dL
- •Estimated GFR less than 30 mL/min
研究组 & 干预措施
Ranolazine
Subjects will be consented by the study investigator and then randomly assigned in an allocation-concealed fashion to double blinded treatment with either titrated doses of ranolazine or matched placebo. After the initial 6 days of treatment with ranolazine, 500 mg twice daily or matched placebo, subjects will undergo repeat 24 hour electrocardiographic monitoring. If tolerated, the subjects will then have their study medication increased (Ranolazine 1,000 mg twice daily or matching placebo) with the plan to then undergo a repeat 24 hour ambulatory electrocardiographic monitoring in 6 days. When the subject returns the monitor, subjects will enter the washout period (cessation of the study medication) for 6 days and have electrocardiographic monitoring prior to return to the subject's referring provider for care.
干预措施: Ranolazine (Drug)
结局指标
主要结局
Reduction in Premature Ventricular Beats
时间窗: 24-hour Holter Monitor after 14 days of therapy
The primary endpoint will be a 50% reduction in premature ventricular beats during 24-hour Holter monitoring after randomization to active treatment or placebo for 14 days of therapy.
次要结局
- Reduction of Premature Atrial Beats(24-hour Holter Monitor after 14 days of therapy)
- Measure Temperature Rebound Rate (TRR)(14 days of therapy)
- Changes in transthoracic echocardiographic parameters(14 days of therapy)
- Frequency of palpitations(14 days of therapy)