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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Toledo Health Science Campus
ClinicalTrials.gov Identifier:
NCT00638222
First received: March 5, 2008
Last updated: December 8, 2010
Last verified: December 2010
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Carvedilol and Micro T-Wave Alternans in Hypertensives With Chronic Kidney Disease

Resource links provided by NLM:

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
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IA
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.
Placebo Comparator: 2A
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

Locations
United States, Ohio
University of Toledo, Health Science Campus
Toledo, Ohio, United States, 43606
United States, Rhode Island
Site Rhode Island Hospital
Providence, Rhode Island, United States, 02903
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: Christopher J Cooper, MD, University of Toledo, Health Science Campus
ClinicalTrials.gov Identifier: NCT00638222     History of Changes
Other Study ID Numbers: UTHSC-08
Study First Received: March 5, 2008
Last Updated: December 8, 2010
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:
Kidney Diseases
Vascular Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Cardiovascular Diseases
Renal Insufficiency
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on June 13, 2013