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

Not Applicable

Terminated

• Conditions: Kidney Disease; Vascular Disease
• Interventions: Other: Carvedilol and Placebo

• Registration Number: NCT00638222
• Lead Sponsor: University of Toledo Health Science Campus

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.

Study Timeline

• Study First Submitted: 2008-03-05
• Study First Submitted QC: 2008-03-18
• Study First Posted: 2008-03-19
• Study Start: 2008-05
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2014-07-08
• Status Verified: 2014-11
• Results First Submitted QC: 2014-11-05
• Last Update Submitted: 2014-11-05
• Results First Posted: 2014-11-13
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
All Study Participants	Carvedilol and Placebo	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.

Primary Outcome Measures

Name	Time	Method
Micro T- Wave Alternans	week 1, 8, 11, 18

Secondary Outcome Measures

Name	Time	Method
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
Oxidized LDL	week 1, 8, 11, 18

Trial Locations

Locations (2)

Site Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States

University of Toledo, Health Science Campus; 🇺🇸 Toledo, Ohio, United States