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

Primary Purpose

Vascular Disease, Kidney Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carvedilol and Placebo
Sponsored by
University of Toledo Health Science Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vascular Disease focused on measuring Carvedilol, Heart Disease, Vascular Disease, Kidney

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Toledo, Health Science Campus
  • Site Rhode Island Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

All Study Participants

Arm Description

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.

Outcomes

Primary Outcome Measures

Micro T- Wave Alternans

Secondary Outcome Measures

Oxidized LDL
Interleukin-6
Plasma C-reactive Protein
Plasma Cardiac Troponin T
Plasma NT-pro BNP
Plasma F2-isoprostanes

Full Information

First Posted
March 5, 2008
Last Updated
November 5, 2014
Sponsor
University of Toledo Health Science Campus
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00638222
Brief Title
Carvedilol and Micro T-Wave Alternans in Hypertensives With Chronic Kidney Disease
Official Title
Carvedilol and Micro T-Wave Alternans in Hypertensives With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toledo Health Science Campus
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Disease, Kidney Disease
Keywords
Carvedilol, Heart Disease, Vascular Disease, Kidney

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Study Participants
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Carvedilol and Placebo
Intervention Description
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 Measure Information:
Title
Micro T- Wave Alternans
Time Frame
week 1, 8, 11, 18
Secondary Outcome Measure Information:
Title
Oxidized LDL
Time Frame
week 1, 8, 11, 18
Title
Interleukin-6
Time Frame
week 1, 8, 11, 18
Title
Plasma C-reactive Protein
Time Frame
week 1, 8, 11, 18
Title
Plasma Cardiac Troponin T
Time Frame
week 1, 8, 11, 18
Title
Plasma NT-pro BNP
Time Frame
week 1, 8, 11, 18
Title
Plasma F2-isoprostanes
Time Frame
week 1, 8, 11, 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Cooper,, MD
Organizational Affiliation
University of Toledo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toledo, Health Science Campus
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Site Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

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

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