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

This study is currently recruiting participants.

Verified by University of Toledo Health Science Campus, August 2009

First Received: March 5, 2008 Last Updated: August 10, 2009 History of Changes

Sponsor:	University of Toledo Health Science Campus
Collaborator:	GlaxoSmithKline
Information provided by:	University of Toledo Health Science Campus
ClinicalTrials.gov Identifier:	NCT00638222

Purpose

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

Condition	Intervention
Vascular Disease Kidney Disease	Drug: Carvedilol Drug: Placebo

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Carvedilol and Micro T-Wave Alternans in Hypertensives With Chronic Kidney Disease

Resource links provided by NLM:

MedlinePlus related topics: Vascular Diseases

Drug Information available for: Carvedilol

U.S. FDA Resources

Further study details as provided by University of Toledo Health Science Campus:

Primary Outcome Measures:

Micro T- Wave Alternans [ Time Frame: week 1, 8, 11, 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Oxidized LDL [ Time Frame: week 1, 8, 11, 18 ] [ Designated as safety issue: No ]
Interleukin-6 [ Time Frame: week 1, 8, 11, 18 ] [ Designated as safety issue: No ]
Plasma C-reactive protein [ Time Frame: week 1, 8, 11, 18 ] [ Designated as safety issue: No ]
Plasma cardiac troponin T [ Time Frame: week 1, 8, 11, 18 ] [ Designated as safety issue: No ]
Plasma NT-pro BNP [ Time Frame: week 1, 8, 11, 18 ] [ Designated as safety issue: No ]
plasma F2-isoprostanes [ Time Frame: week 1, 8, 11, 18 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	May 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
IA: Active Comparator Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.	Drug: Carvedilol Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.
2A: Placebo Comparator Subjects will receive placebo for 8 weeks then be given study drug for 8 more.	Drug: Placebo Subjects will receive placebo for 8 weeks then be given study drug for 8 more.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638222

Contacts

Contact: Holly Burtch, RN	419-383-6289	holly.burtch@utoledo.edu
Contact: Christopher Cooper, MD	419-383-3697	christopher.cooper@utoledo.edu

Locations

United States, Ohio
University of Toledo, Health Science Campus	Recruiting
Toledo, Ohio, United States, 43606
Contact: Christopher Cooper, MD 419-383-3697 christopher.cooper@utoledo.edu
Contact: Holly Burtch, RN 419-383-6289 holly.burtch@utoledo.edu
United States, Rhode Island
Site Rhode Island Hospital	Recruiting
Providence, Rhode Island, United States, 02903
Contact: Lance Dworkin
Contact: Ann Marie O'Mara 401-444-8554 AOmara@Lifespan.org
Principal Investigator: Lance Dworkin, MD

Sponsors and Collaborators

University of Toledo Health Science Campus

GlaxoSmithKline

Investigators

Principal Investigator:

Christopher Cooper, , MD

University of Toledo

More Information

No publications provided

Responsible Party:	University of Toledo, Health Science Campus ( Christopher J Cooper, MD )
Study ID Numbers:	UTHSC-08
Study First Received:	March 5, 2008
Last Updated:	August 10, 2009
ClinicalTrials.gov Identifier:	NCT00638222 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Toledo Health Science Campus:

Carvedilol
Heart Disease
Vascular Disease
Kidney

Additional relevant MeSH terms:

Vasodilator Agents
Renal Insufficiency
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Kidney Failure, Chronic
Vascular Diseases
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Urologic Diseases
Renal Insufficiency, Chronic
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Kidney Diseases
Kidney Failure
Carvedilol

ClinicalTrials.gov processed this record on November 20, 2009