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

November 5, 2014 updated by: Christopher Cooper, MD, University of Toledo Health Science Campus
Evaluate effectiveness of Carvedilol CR on Micro T-Wave Alternans in high risk hypertensives

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Toledo, Ohio, United States, 43606
        • University of Toledo, Health Science Campus
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Site Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Micro T- Wave Alternans
Time Frame: week 1, 8, 11, 18
week 1, 8, 11, 18

Secondary Outcome Measures

Outcome Measure
Time Frame
Oxidized LDL
Time Frame: week 1, 8, 11, 18
week 1, 8, 11, 18
Interleukin-6
Time Frame: week 1, 8, 11, 18
week 1, 8, 11, 18
Plasma C-reactive Protein
Time Frame: week 1, 8, 11, 18
week 1, 8, 11, 18
Plasma Cardiac Troponin T
Time Frame: week 1, 8, 11, 18
week 1, 8, 11, 18
Plasma NT-pro BNP
Time Frame: week 1, 8, 11, 18
week 1, 8, 11, 18
Plasma F2-isoprostanes
Time Frame: week 1, 8, 11, 18
week 1, 8, 11, 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toledo Health Science Campus

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Christopher Cooper,, MD, University of Toledo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria

March 18, 2008

First Posted (Estimate)

March 19, 2008

Study Record Updates

Last Update Posted (Estimate)

November 13, 2014

Last Update Submitted That Met QC Criteria

November 5, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTHSC-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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