Hypertension in Hemodialysis Patients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year.
研究概览
简要总结
We will directly test the hypothesis that an initial strategy of lisinopril-based therapy will be more effective than atenolol-based therapy in causing regression of left ventricular hypertrophy (LVH) over one year in patients with hemodialysis hypertension despite similar degree of BP reduction.
详细描述
This is a parallel group, active control, single-center, open-label, randomized controlled trial comparing the safety and efficacy of initial therapy with an angiotensin converting enzyme (ACE) inhibitor (lisinopril) vs. beta-blocker therapy (atenolol) each administered three times weekly after dialysis.
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
- 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
- •Patients on chronic hemodialysis for > 3 mos.
- •Compliance with hemodialysis treatments as defined by less than one missed dialysis per month
- •Hypertension as diagnosed by ambulatory blood pressure monitoring (ABPM) >135/75 mm Hg after participation in the ultrafiltration (UF) Trial, or those on no antihypertensive medications but unwilling to do UF Trial.
- •Presence of LVH on echocardiogram defined as left ventricular mass index (LVMi) >104 g/m2 in women and >116 g/m2 in men.
- •Willingness to give informed consent.
- •Exclusion criteria:
- •Vascular event (stroke, myocardial infarction or limb ischemia requiring bypass) within previous six months
- •Noncompliance with hemodialysis treatments
- •Known drug abuse
- •Chronic obstructive pulmonary disorder (COPD) requiring home oxygen
- •Congestive Heart Failure Class III or IV.
- •Body mass index > 40 kg/m
- •Known contraindication to atenolol (severe heart failure, bradycardia, bronchial asthma, intolerance or allergy) or lisinopril (cough, pregnancy, intolerance or allergy)
排除标准
- 未提供
研究组 & 干预措施
1
Atenolol
干预措施: Atenolol (Drug)
2
Lisinopril
干预措施: Lisinopril (Drug)
结局指标
主要结局
The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year.
时间窗: Baseline, 6 months, 12 months
The primary outcome of the study was the average reduction in left ventricular mass indexed for body surface area from baseline to 1 year. A mixed model was used with left ventricular mass index (LVMI) as the outcome variable. Fixed effects were indicator variables for time, treatment and their interaction. Random effect was subject and statistical inference was made using the maximum likelihood estimator. No imputation was made for missing data.
次要结局
未报告次要终点