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

Study Overview
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Brief Summary
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Evaluate effectiveness of Carvedilol CR on Micro T-Wave Alternans in high risk hypertensives

Detailed Description
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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.

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

Conditions
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Vascular Disease, Kidney Disease

Intervention / Treatment
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* Other: Carvedilol and Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: All Study Participants<br>All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately. | Other: Carvedilol and Placebo<br>* All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Micro T- Wave Alternans |  | week 1, 8, 11, 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidized LDL |  | week 1, 8, 11, 18 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney, Carvedilol, Heart Disease, Vascular Disease