The Effect of Statin Therapy (Atorvastatin) on the Progression of Calcific Valvular Aortic Stenosis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Aortic Stenosis
研究概览
简要总结
The purpose of this study is to find out if an approved medicine that is used to lower cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve in patients with a condition called aortic stenosis. Patients who have aortic stenosis who volunteer for this study will take Lipitor for 2 years and will undergo a brief exam by a physician, labwork to measure cholesterol, and a routine heart ultrasound (sound picture of the heart) at the start of the study and every 6 months, stopping at 2 years.
详细描述
This is a prospective, single-center study assessing the effect of atorvastatin 40 mg/day (Lipitor, Pfizer) on the progression of calcific aortic stenosis in approximately 70 patients with mild to moderate calcific AS of a tricuspid or bicuspid aortic valve. As a control population, published data on historical AS cohorts will be used, employing the accepted rate of progression of a decrease in aortic valve area of 0.1 cm²/year. Additionally, also for comparison, we will prospectively study a registry of AS patients who meet our entry criteria but are either currently already being treated with or refuse to take an HMG-CoA reductase inhibitor (referred to as the "standard care" group).
All patient visits, laboratory studies, and echocardiograms will be performed at the Cleveland Clinic Foundation in Cleveland, Ohio with the exception of the 12-week visit ALT measurement which may be done at the patient's local doctor's office and the results faxed to Imaging Research. The 12-week follow-up assessment may be completed over the phone to establish any change in patient status since baseline, study medication compliance, concomitant medication use and to ascertain whether or not the appropriate laboratory test was obtained. Over a 2-year period, assessments will be conducted at baseline, 6, 12, 18, and 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Mild to moderate calcific AS of a tricuspid or bicuspid aortic valve
- •Echocardiographic derived mean pressure gradient >10 mmHg and an aortic valve area of 0.9 to 1.7 cm2 by continuity equation.
- •Laboratory evidence of LDL-c>70 mg/dl within 12 months prior to recruitment.
排除标准
- •Left ventricular ejection fraction <50%
- •Valvular area of 0.9 cm2 and a mean gradient >30 mmHg
- •Rheumatic heart disease
- •>Moderate (2+) aortic insufficiency
- •Prior statin therapy to include: >10 mg of atorvastatin (Lipitor) or >20 mg of other HMG-CoA Reductase Inhibitors (statins)
- •End-stage renal disease (ESRD)
- •History of thoracic radiation
- •Unable or unwilling to sign informed consent
- •Unable to unwilling to return for follow-up
- •Other clinically important renal, pulmonary, hepatic, neurological, endocrine, or hematological disorders, vasculitis, or any other situation or medical condition that, in the investigator's opinion, would make survival for the duration of the study unlikely, or would otherwise interfere with optimal participation in the study or produce a significant risk to the patient
- •Severe pulmonary hypertension (>55 mmHg)
研究组 & 干预措施
AORTIC STENOSIS PATIENTS
Atorvastatin (Lipitor) 40mg by mouth daily is administered to patients with aortic stenosis
干预措施: atorvastatin (Lipitor) (Drug)
结局指标
主要结局
Aortic Stenosis
时间窗: 2 years
aortic valve area as measured by transthoracic echocardiography was not obtained due to poor reproducibility
次要结局
- Rate of Change in the Aortic Valve Area Measured by Transthoracic Echocardiography Compared to That of Historical Controls(2 years)
- Rate of Change in the Aortic Valve Area Measured by TEE Compared to That of Historical Controls(2 years)
- Rate of Change in Aortic Valve Area as Measured by TEE Compared to Standard of Care Group(2 years)
- Change in Mean and Peak Gradients Across the Aortic Valve as Measured by TEE in the Treated Group Compared to Historical Control Group.(2 years)