Statin Induced Regression of Cardiomyopathy Trial - SirCat
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in left ventricular mass at 12 months from baseline
研究概览
简要总结
The purpose of this study is to determine if a drug called atorvastatin will reduce the size and stiffness of the muscle in the left ventricle of the heart.
详细描述
Hypertrophic cardiomyopathy (HCM) is a primary disorder of the heart characterized by a thickened, fibrotic myocardium, with or without a dynamic left ventricular outflow tract gradient. It is a common heritable cardiovascular disease, with a population prevalence of 0.1% to 0.2%. Symptoms of congestive heart failure are extremely common in patients with HCM. Progression to disabling and debilitating symptoms [New York Heart Association (NYHA) class III and IV] is relatively common, occurring in 15% to 20% of unselected populations. The rate of progression to NYHA class III or IV or death from heart failure or stroke is high, with a relative risk 2.7. Management of symptoms can be very challenging, involve multiple medications, and 5% of patients may develop drug refractory heart failure, requiring invasive intervention. HCM is the most common cause of sudden death among young competitive athletes. Ventricular tachyarrhythmias appear to be the primary mechanism; however, other arrhythmias involved include asystole, rapid atrial fibrillation, and electrical mechanical dissociation. Patients may develop progressive myocardial wall thinning, a reduction in systolic performance, and an increase in left ventricular dimensions. Progressive wall thinning may be especially common in patients with initially severe hypertrophy. There is no cure for this condition. There is now evidence from both animal and human studies of a treatment that promises to reverse hypertrophy - HMG CoA reductase inhibitors. Clearly, studies of treatments that might cause regression of hypertrophy are timely and important.
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
- 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
- •18 years and over with HCM in the absence of another cardiac or systemic disease capable of producing a prespecified wall thickening
排除标准
- •Required use of statin therapy or intolerance
- •A clinical diagnosis of hypertension
- •Indication for statin therapy for primary or secondary prevention of coronary artery disease
- •Current or anticipated indication in ≤ 1 year for implantable cardioverter defibrillators or other metallic devices preventing cardiac magnetic resonance imaging (MRI).
研究组 & 干预措施
1
Atorvastatin
干预措施: Atorvastatin (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in left ventricular mass at 12 months from baseline
时间窗: 12 months
次要结局
- a decrease in the volume of dense myocardial fibrosis(12 months)
- parameters of diastolic function(12 months)
- a decrease in maximal ventricular wall cross sectional width(12 months)
- a decrease in the incidence of nonsustained ventricular tachycardia(12 months)
- a decrease in T-wave alternans(12 months)
研究者
Dr. Bob Sheldon
Professor of Cardiac Sciences, Medicine and Medical Genetics
University of Calgary
