Official Title: “Carvedilol and Micro T-Wave Alternans in Hypertensives With Chronic Kidney Disease”

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

Study Type: Interventional

Study Design: Prevention, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Carvedilol
  • Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.
• Drug: Placebo
  • Subjects will receive placebo for 8 weeks then be given study drug for 8 more.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: IA
  • Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.
• Placebo Comparator: 2A
  • Subjects will receive placebo for 8 weeks then be given study drug for 8 more.

Primary Measures

• Micro T- Wave Alternans
  • Time Frame: week 1, 8, 11, 18
    Safety Issue?: No

Secondary Measures

• Oxidized LDL
  • Time Frame: week 1, 8, 11, 18
    Safety Issue?: No
• Interleukin-6
  • Time Frame: week 1, 8, 11, 18
    Safety Issue?: No
• Plasma C-reactive protein
  • Time Frame: week 1, 8, 11, 18
    Safety Issue?: No
• Plasma cardiac troponin T
  • Time Frame: week 1, 8, 11, 18
    Safety Issue?: No
• Plasma NT-pro BNP
  • Time Frame: week 1, 8, 11, 18
    Safety Issue?: No
• plasma F2-isoprostanes
  • Time Frame: week 1, 8, 11, 18
    Safety Issue?: No

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Toledo Health Science Campus

Overall Clinical Trial Officials and Contacts

Christopher Cooper, , MD Principal Investigator University of Toledo  

Overall Contact: Mary Ann Ankenbrandt, , RN 419-383-6293 Maryann.ankenbrandt@utoledo.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00638222

Study ID Number: UTHSC-08

ClinicalTrials.gov Identifier: NCT00638222

Health Authority: United States: Institutional Review Board