Efficacy of L-methylfolate and Methylcobalamine in Treating Resistant Hypertension Associated with Elevated Serum Homocysteine in Hemodialysis Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- average pre-dialysis blood pressure target of ≤ 140/90 mm Hg or an average post-dialysis blood pressure target of ≤ 130/80 mm Hg
研究概览
简要总结
The aim of the study is to evaluate the efficacy of L-methylfolate in combination with methylcobalamine in reducing homocysteine blood levels in hypertensive end-stage renal disease patients on regular hemodialysis and its association with blood pressure control in treatment of resistant hypertension
详细描述
- Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University
- Agreement from all participants should be taken in this clinical study by assigning an informed consent
- Adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension will be recruited from hemodialysis unit in Alexandria University Hospitals
- Patients will be screened for resistant hypertension as determined by the mean of mid-week pre-dialysis BP > 140/90 mm Hg, post-dialysis BP > 130/80 mm Hg over a period of one month.
- A blood sample will be collected for homocysteine measurement at baseline
- Patients will be randomized using simple randomization technique via computer based program to take one tablet daily containing L-methylfolate and methylcobalamine or no treatment.
- Patients will be followed over a period of 3 months after which blood pressure measurement and blood sampling would be repeated and compared to baseline values
- As a measurement of the prognosis of elevated homocysteine, we should follow the development of myocardial infarction, stroke and cardiovascular events for 3 months
- The appropriate statistical tests will be held according to the study design and parameters to evaluate the significance of the results
- Results, conclusion, discussion and recommendations will be given
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension as determined by pre-dialysis BP > 140/90 mm Hg, post-dialysis BP > 130/80 mm Hg despite the use of three or more drugs
排除标准
- •Age > 75 years
- •Excessive use of alcohol or smoking
- •Severe hepatic impairment
- •Acute kidney injury on top of chronic kidney disease
- •Pregnant females
- •Allergy or intolerance to any component of the formulation
- •Medication side effects (methotrexate, theophylline, phenytoin, and cyclosporine) or any drug proven to cause hyperhomocysteinemia
研究组 & 干预措施
Experimental: Intervention group
Adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension as determined by pre-dialysis BP > 140/90 mm Hg, post-dialysis BP > 130/80 mm Hg despite the use of three or more drugs.
Patients will be assigned to take one tablet daily containing L-methylfolate and methylcobalamine.
Patients will be followed over a period of 3 months after which blood pressure measurement and blood sampling would be repeated and compared to baseline values.
干预措施: L-Methyl Folate and methylcobalamine (Drug)
结局指标
主要结局
average pre-dialysis blood pressure target of ≤ 140/90 mm Hg or an average post-dialysis blood pressure target of ≤ 130/80 mm Hg
时间窗: 3 months
To achieve an average pre-dialysis blood pressure target of ≤ 140/90 mm Hg or an average post-dialysis blood pressure target of ≤ 130/80 mm Hg. This should be parallel to lowering of serum homocysteine compared to baseline values
次要结局
- myocardial infarction, stroke and cardiovascular events.(3 months)