Effect of the Addition of Simvastatin to Enalapril in Hypertensive Individuals With Average Cholesterol Levels and Diastolic Dysfunction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Changes in E/A ratio and e' wave velocity
研究概览
简要总结
Diastolic dysfunction (DD) is an increasingly frequent condition in hypertensive individuals whose treatment remains unclear. Its presence is related to higher morbidity and mortality independent of blood pressure levels. The aim of this study is to investigate the additive effect of simvastatin on enalapril on DD in hypertensive patients with average cholesterol levels.
For this aim, hypertensive patients with DD and LDL-cholesterol <160 mg/dL will undergo a run-in phase to achieve a systolic blood pressure (SBP) <135 mmHg and diastolic blood pressure (DBP) <85 mmHg with enalapril. Hydrochlorothiazide could be added when need to achieve SBP or DBP control. Four weeks after reaching the optimum anti-hypertensive regimen patients will be randomized to receive 80 mg simvastatin or placebo for a period of 20 weeks. Echocardiograms will be performed before and after treatment with measurement of left atrial volume, conventional and tissue Doppler velocities in early diastole and late diastole. The evaluation of these will allow to identify changes of DD severity after treatment.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men or postmenopausal women aged between 40 and 65 years old
- •normal fasting blood glucose (<100 mg/dL) and glucose tolerance test (<140 mg/dL)
- •waist circumference < 102 cm (men) or < 88cm (women)
- •triglycerides <150 mg/dL, LDL cholesterol ≤ 160 mg/dl
- •creatinine <1.2 mg/dL, sinus rhythm
- •the presence of grade 1 or 2 of DD with an ejection fraction of left ventricle > 55%
- •absence of myocardial ischemia during dobutamine stress echocardiography
排除标准
- •thyroid dysfunction
- •acute or chronic liver disease
- •regular use of 3 or more antihypertensive drugs
- •secondary hypertension
- •symptoms or history of atherosclerotic disease
- •valvular dysfunction
- •LVH 14 and use of statins in the last 6 months
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
Simvastatin
Simvastatin 80 mg/day
干预措施: Simvastatin (Drug)
结局指标
主要结局
Changes in E/A ratio and e' wave velocity
时间窗: 20 weeks
次要结局
- Changes in the ratio of mitral inflow velocity to annular relaxation velocity.(20 weeks)
- Changes in e´/a´ waves ratio.(20 weeks)
- Changes in mitral deceleration time.(20 weeks)
- Changes in left atrium volume.(20 weeks)
- Changes in left ventricular mass.(20 weeks)
- Changes in mitral annulus systolic velocity(20 weeks)
- Diastolic function reserve index measured at peak stress with dobutamine(20 weeks)