Early and Late Cardiac Effects of Arteriovenous Fistula Creation for Haemodialysis in End-stage Renal Failure and Their Possible Attenuation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- left ventricular hypertrophy
研究概览
简要总结
The primary objective is to determine if the use of losartan, an angiotensin II receptor blocker, can attenuate left ventricular hypertrophy, independent of its antihypertensive effects, in patients with near end stage chronic kidney disease (CKD) who have an arteriovenous fistula created.
Secondary outcomes include the impact of the medication on BNP and hyperkalaemia
详细描述
Study Design: This is a prospective double blind placebo control 2 arm, randomized (1:1) parallel group study in patients with near end stage renal failure who require creation of an arteriovenous fistula for future haemodialysis. Enrolment will be over a period of 12 months. The blinded phase will be for 3 months. The study design is summarized in Appendix 1. The study consists of a screening phase, a randomization phase and a treatment phase.
Patients will be randomized into 2 groups:
- Group 1 Losartan (50mg daily blinded) and 25 mg of atenolol
- Group 2 Placebo (blinded) and 25 mg of atenolol
Patients: Patients must comply with specified inclusion and exclusion criteria. The number of patients used will be sufficient to show a 15% difference in the left ventricular mass (LVM) between the two groups
Study Endpoints: The primary endpoint is the between group difference in LVM from baseline to 1 month.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CKD at near-end stage renal failure (CKD Stage IV) ( eGFR = 15-30 mls/min).
- •Age >18 years of age and <85 years of age.
- •Males and post-menopausal, sterile women. Non-pregnant pre-menopausal women should be on adequate contraception and have no intention of becoming pregnant during the duration of the study.
- •At baseline TTE LVEF>45%
- •Willing and able to give informed consent.
排除标准
- •Serum potassium level of more than 5.5 mmol/L
- •Acute myocardial infarction or cerebrovascular accident in the previous 6 months.
- •Severe uncontrolled hypertension (diastolic BP >100mmHg or systolic BP >160 mmHg)
- •Evidence or suspicion of renovascular disease.
- •Atrial fibrillation
- •Evidence or suspicion of collagen disease, cancer, psychiatric disorder that interferes with patient compliance, drug or alcohol abuse, pregnancy, breast feeding and ineffective contraception.
结局指标
主要结局
left ventricular hypertrophy
时间窗: 3 months
次要结局
未报告次要终点