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临床试验/NCT04085562
NCT04085562已完成4 期

Effect of Amlodipine Versus Bisoprolol on Hypertensive Patients With End-stage Renal Disease on Maintenance Hemodialysis.

Alexandria University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2019年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
46
试验地点
1
主要终点
Change in Left Ventricular Mass Index

研究概览

简要总结

Hypertension is highly prevalent in hemodialysis (HD) patients and leads to increased morbidity and mortality due to cardiovascular disease(CVD). Left ventricular hypertrophy (LVH) is both a manifestation of hypertension caused end-organ damage and an independent risk factor for CVD. Evidence shows that Beta-blockers, especially of low dialyzability decrease risk of CVD and mortality. Calcium channel blockers (CCBs) were also shown to effectively control BP in the volume expanded state and reduce cardiovascular disease risk. Asymmetric dimethyl arginine (ADMA) is a uremic toxin that decreases NO synthesis and is correlated to LVH, carotid intimal thickness (CIT), CVD, and mortality. Amlodipine is shown in one study to significantly reduce ADMA level in HD patients. The purpose of this study is to determine the effect of calcium channel blocker Amlodipine compared to Beta-blocker Bisoprolol on regression of LVH, reduction of ADMA plasma level and on BP control among hypertensive patients on HD.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • On maintenance hemodialysis 3 times weekly for at least 3 months.
  • Hypertensive as determined by predialytic BP > 140/ 90, post-dialytic > 130/80, home-measured BP >140/90, Office based BP >140/90 and/or on antihypertensive medication.

排除标准

  • History of malignancy.
  • History of significant valvular heart disease.
  • Chronic congestive heart failure.
  • History of coronary artery disease.
  • Ongoing atrial fibrillation.
  • Known drug abuse.
  • Known contraindication to Bisoprolol or Amlodipine.
  • History of MI
  • History of Stroke

研究组 & 干预措施

Amlodipine

Experimental

Hypertensive patients on dialysis receiving Amlodipine 5-10 mg tablet daily alone or as part of antihypertensive regimen.

干预措施: Amlodipine 5-10 mg (Drug)

Bisoprolol

Experimental

Hypertensive patients on dialysis receiving Bisoprolol 5-10 mg tablet daily alone or as part of antihypertensive regimen.

干预措施: Bisoprolol Fumarate 5-10 mg (Drug)

结局指标

主要结局

Change in Left Ventricular Mass Index

时间窗: 6 months

次要结局

  • Change in ADMA Blood level(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Youssef

Teaching assistant

Alexandria University

研究点 (1)

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