Randomized control trial to compare effect of Atenolol vs Telmisartan in hemodialysispatients with uncontrolled hypertension.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- PRIMARY OUTCOME
研究概览
简要总结
Cardiovascular events resulting from uncontrolled hypertension is a leading cause of
death in chronic hemodialysis patients. Despite the significant degree of mortality and morbidity,
there is a lot of lacunae in our understanding of an ideal drug to control blood pressure for
prevention of cardiovascular disease in this population. The majority of cardiovascular primary
and secondary prevention clinical trials have excluded patients on hemodialysis. We are doing
this trial to compare two common drugs- Atenolol and Telmisartan in hemodialysis patients with
uncontrolled blood pressure. Efficacy of the drug will be analysed by BP control, reduction of
LVMI (left ventricular mass index) on 2D ECHO. We will also analyse the safety of these 2
drugs in this population. In case any patients develops any side effect, this drug will be
immediately stopped and treatment will be provided to the patient free of cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All the end stage kidney disease patients, above 18 years of age with written informed consent.
- •On Hemodialysis (CKD stage VD) for more than 3 months. Average of Home BP readings should be more than 135/85mmHg. These readings should be collected in the morning and in the evening over 6 non-dialysis days (covering a period of 2 weeks). OR.
- •ABPM reading with an average BP of more than 130/80mmHg over 24-h monitoring during a mid-week day free of haemodialysis.
排除标准
- •Patients less than 18 yrs of age.
- •Patient with pregnancy.
- •Patients with obstructive airway disease, peripheral vascular disease, uncontrolled blood sugar levels.
- •Patients with persistent hyperkalemia [K > 6meq/L], or with ECG changes of hyperkalemia
- •Patients planned to undergo renal transplant within 1 year.
- •Patients with CV events in the last 3 months
- •Patients unwilling to give consent.
结局指标
主要结局
PRIMARY OUTCOME
时间窗: 12 months
Decrease in Echocardiographic Left Ventricular hypertrophy and Left Ventricular Mass Index at the end of 1 year
时间窗: 12 months
次要结局
- SECONDARY OUTCOME(Composite Cardiovascular outcome at the end of one year which include heart failure,coronary revascularization (PTCA/ CABG), myocardial ischemia, angina requiring hospitalization,)