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

NCT ID: NCT00638222

Last Updated: 2014-11-13

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Vascular Disease Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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All Study Participants

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.

Group Type ACTIVE_COMPARATOR

Carvedilol and Placebo

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

University of Toledo Health Science Campus

OTHER

Sponsor Role lead

Responsible Party

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Christopher Cooper, MD

Professor, Interim Chair/Dir Cardiovas Research Cntr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Cooper,, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toledo

Locations

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University of Toledo, Health Science Campus

Toledo, Ohio, United States

Site Status

Site Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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UTHSC-08

Identifier Type: -

Identifier Source: org_study_id