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临床试验/NCT00638222
NCT00638222终止不适用

Carvedilol and Micro T-Wave Alternans in Hypertensives With Chronic Kidney Disease

University of Toledo Health Science Campus4 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2008年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
6
试验地点
4
主要终点
Micro T- Wave Alternans

研究概览

简要总结

Evaluate effectiveness of Carvedilol CR on Micro T-Wave Alternans in high risk hypertensives

详细描述

The effect of Carvedilol CR on Micro T-Wave Alternans will be assessed in 30 hypertensives with stage 4 or 5 chronic kidney disease utilizing a cross-over design and contrasting no treatment against active treatment periods of 8 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults age 18 and older
  • Chronic kidney disease
  • Must be able to do stress test

排除标准

  • Must not be mentally disabled
  • Unable to provide informed consent
  • Unable or unwilling to comply with study protocol or procedures
  • Pregnancy or unknown pregnancy status in female of childbearing potential
  • Participation in any drug trial during the study period
  • Prior enrollment in this study
  • Active liver disease
  • Currently on β-blocker medication at the time of enrollment
  • Known history of asthma exacerbation with β-blocker therapy
  • Second or third degree AV nodal block or bradycardia with resting heart rate <50 bpm
  • Prior allograft organ transplantation
  • Planned allograft transplantation reasonably foreseen within the active treatment period
  • Electrocardiographic left or right bundle branch block
  • Permanent implanted pacemaker
  • Atrial fibrillation
  • Ongoing treatment with any of the following medications: sotalol (Betapace), azimilide (Stedicor), quinidine (Quinidex), disopyramide (Norpace), dofetilide (Tikosyn), ibutilide (Corvert), procainamide (Procanbid), bepridil (Vascor), amiodarone (Cordarone), clarithromycin (Biaxin), erythromycin (Eryc), halofantrine (Halfan), pentamidine (Pentam), sparfloxacin (Zagam), domperidone (Motilium), droperidol (Inapsine), chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), thioridazine (Mellaril), pimozide (Orap), arsenic trioxide (Trisenox), cisapride (Propulsid), lidoflazine (Clinium), and methadone (Dolophine)

结局指标

主要结局

Micro T- Wave Alternans

时间窗: week 1, 8, 11, 18

次要结局

  • Interleukin-6(week 1, 8, 11, 18)
  • Plasma C-reactive Protein(week 1, 8, 11, 18)
  • Plasma Cardiac Troponin T(week 1, 8, 11, 18)
  • Plasma NT-pro BNP(week 1, 8, 11, 18)
  • Plasma F2-isoprostanes(week 1, 8, 11, 18)
  • Oxidized LDL(week 1, 8, 11, 18)

研究者

发起方
University of Toledo Health Science Campus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Cooper, MD

Professor, Interim Chair/Dir Cardiovas Research Cntr

University of Toledo Health Science Campus

研究点 (4)

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