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

Condition(s) targeted: Vascular Disease; Kidney Disease

Intervention: Carvedilol (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Toledo Health Science Campus

Official(s) and/or principal investigator(s):
Christopher Cooper, , MD, Principal Investigator, Affiliation: University of Toledo

Overall contact:
Holly Burtch, RN, Phone: 419-383-6289, Email: holly.burtch@utoledo.edu

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

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

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

Primary outcome: Micro T- Wave Alternans

Secondary outcome:

Oxidized LDL

Interleukin-6

Plasma C-reactive protein

Plasma cardiac troponin T

Plasma NT-pro BNP

plasma F2-isoprostanes

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Holly Burtch, RN, Phone: 419-383-6289, Email: holly.burtch@utoledo.edu

University of Toledo, Health Science Campus, Toledo, Ohio 43606, United States; Recruiting
Christopher Cooper, MD, Phone: 419-383-3697, Email: christopher.cooper@utoledo.edu
Holly Burtch, RN, Phone: 419-383-6289, Email: holly.burtch@utoledo.edu

Site Rhode Island Hospital, Providence, Rhode Island 02903, United States; Recruiting
Lance Dworkin
Ann Marie O'Mara, Phone: 401-444-8554, Email: AOmara@Lifespan.org
Lance Dworkin, MD, Principal Investigator

Starting date: May 2008
Ending date: March 2010
Last updated: August 10, 2009