Clinical trial NCT00638222: Carvedilol and Micro T-Wave Alternans in Hypertensives With Chronic Kidney Disease
Official title: Carvedilol and Micro T-Wave Alternans in Hypertensives With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vascular Disease
Kidney Disease
Keywords: Carvedilol
Heart Disease
Vascular Disease
Kidney
Lead sponsor: University of Toledo
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2008-03-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Micro T- Wave Alternans
timeFrame: week 1, 8, 11, 18
Secondary outcomes:
measure: Oxidized LDL
timeFrame: week 1, 8, 11, 18
measure: Interleukin-6
timeFrame: week 1, 8, 11, 18
measure: Plasma C-reactive Protein
timeFrame: week 1, 8, 11, 18
measure: Plasma Cardiac Troponin T
timeFrame: week 1, 8, 11, 18
measure: Plasma NT-pro BNP
timeFrame: week 1, 8, 11, 18
measure: Plasma F2-isoprostanes
timeFrame: week 1, 8, 11, 18
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo, Health Science Campus
state: Ohio
city: Providence
country: United States
facility: Site Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: University of Toledo
name: Christopher Cooper,, MD
role: PRINCIPAL_INVESTIGATOR
References: