Aldosterone Blockade to Prevent Myocardial Remodeling In Patients With Controlled Essential Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Myocardial Remodeling (cardiac chamber sizes, wall thickness, left ventricular ejection fraction, left atrial volumes, and diastolic function) assessed by transthoracic echocardiogram
研究概览
简要总结
The goal of this project is to investigate the effects that the addition of aldosterone blockade with eplerenone will have on the progression of diastolic dysfunction in patients with controlled essential hypertension.
详细描述
The purpose of this project is to determine if eplerenone, an aldosterone blocker, prevents remodelling of the heart in patients with controlled essential hypertension, defined as having a blood pressure of equal to or less than 130/80 in diabetics and equal to or less than 140/90 in non-diabetics. This study will investigate if the addition of 25 milligrams of eplerenone daily to a subject's hypertension medication regimen will prevent the progression or development of diastolic dysfunction. Echocardiography will be used to measure the changes in heart structure of subjects receiving eplerenone versus subjects receiving placebo (a drug that may resemble the study drug but contains no active ingredient). Approximately 30 subjects will take part in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated and controlled hypertension
- •Less than 140/90 in non-diabetics
- •Less than 130/80 in diabetics
排除标准
- •currently receiving an aldosterone blocker
- •clinical evidence of congestive heart failure
- •prior myocardial infarction
- •renal dysfunction with a creatinine clearance of less than 40ml/min
- •serum potassium > 5.5meq/L at initiation
- •concomitant use of a medication that inhibits the CYP3A4 enzyme (ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir)
研究组 & 干预措施
Lactose Tablet
Compounded capsule using Lactose Monohydrate Powder
干预措施: Lactose Tablet (Drug)
Eplerenone
25 mg tablet placed in a capsule filled with Lactose Monohydrate Powder.
干预措施: Eplerenone (Drug)
结局指标
主要结局
Myocardial Remodeling (cardiac chamber sizes, wall thickness, left ventricular ejection fraction, left atrial volumes, and diastolic function) assessed by transthoracic echocardiogram
时间窗: 6 months
次要结局
- Blood Pressure(6 months)