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

University of Toledo Health Science Campus

Status: Terminated

Conditions: Vascular Disease; Kidney Disease

Treatments: Other: Carvedilol and Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00638222

UTHSC-08

Details and patient eligibility

About

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

Full description

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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6 participants in 1 patient group

All Study Participants

Active Comparator group

Description:

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.

Treatment:

Other: Carvedilol and Placebo