NCT01721967已完成4 期
Ranolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy Investigation
Duke University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2012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
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Drug Tolerability
研究概览
简要总结
The purpose of RHYME is to evaluate the safety and efficacy of ranolazine in Hypertrophic Cardiomypathy patients with chest pain or dyspnea despite treatment with standard medical therapy. This is a small, pilot, open-label (non-randomized) study of an approved drug for the treatment of angina in a novel patient population (adult patient population with hypertrophic cardiomyopathy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Age 18 years or older
- •Left Ventricle wall thickness >/= 15mm in the absence of other condition causing hypertrophy
- •Baseline Angina/Shortness of Breath Frequency of > 2 episodes per week
- •Willing to provide informed consent
排除标准
- •Severe stenotic valvular disease
- •Severe valvular regurgitation except mitral regurgitation due to systolic anterior motion
- •Significant (>60% stenosis) coronary artery disease
- •Acute coronary syndrome within 30 days
- •Severe heart failure defined as LV systolic dysfunction with Ejection Fraction <40% or NYHA class 4 symptoms
- •Severe renal impairment (glomerular filtration rate, <30 mL/min/1.73 m2)
- •Moderate-severe hepatic impairment (Child-Pugh classes B and C)
- •Hospitalization for cardiac reason within 3 months of enrollment
- •Anticipated changes to treatment of HCM within study period, including medications, device implantation, or septal reduction therapies
- •Concomitant use of ketoconazole, macrolide antibiotics, and HIV protease inhibitors
- •Active myocarditis, pericarditis, or restrictive cardiomyopathy
- •Non-cardiac terminal illness with expected survival less than 6 months
- •Women who are of childbearing potential
- •Inability to perform or adhere to study protocol
研究组 & 干预措施
Ranolazine
Experimental
Ranolazine, 500 mg for 60 days
干预措施: Ranolazine (Drug)
结局指标
主要结局
Drug Tolerability
时间窗: 60 days
Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose
Number of Adverse Events Considered Probably or Possibly Related to Study Drug
时间窗: 60 Days
Number of events that are considered probably or possibly related to study drug.
QT Interval
时间窗: 60 Days
次要结局
- Seattle Angina Questionnaire (SAQ)(60 Days post treatment)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(60 days post treatement)
- Improvement in Number of Episodes of Angina Per Week(Baseline and 60 Days post treatment)
研究者
研究点 (1)
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