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Reversal of Ventricular Remodeling With Toprol-XL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00038077
Recruitment Status : Completed
First Posted : May 29, 2002
Last Update Posted : November 19, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
The purpose of this study is to determine whether treatment with Toprol-XL for 12 months in asymptomatic heart failure subjects will improve their heart structure and thus prevent the progression to symptomatic disease.

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Drug: Seloken ZOK/Toprol-XL Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 2001
Actual Primary Completion Date : September 2003
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Intervention Details:
  • Drug: Seloken ZOK/Toprol-XL
    50 mg
    Other Name: Toprol-XL
  • Drug: Seloken ZOK/Toprol-XL
    200 mg
    Other Name: Toprol-XL
  • Drug: Placebo

Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of stable asymptomatic heart failure.
  • Documented ejection fraction less than 0.40.
  • Must be able to comply with all study procedures.

Exclusion Criteria:

  • Taken B-blocker therapy for longer than 1 week within 6 months prior to randomization.
  • Have heart problems that would not allow B-blocker therapy.
  • Receiving B-blockers therapy for any medical reason including topical B-blockers that might cause systemic absorption (e.g., glaucoma).
  • Undergone certain heart surgeries, such as, prior heart transplant or cardiomyoplasty.
  • Have certain heart diseases.
  • Pregnant or breast feeding.
  • Unlikely to survive.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038077


Locations
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United States, Alabama
Birmingham, Alabama, United States
Mobile, Alabama, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Los Angeles, California, United States
Northridge, California, United States
Redondo Beach, California, United States
Riverside, California, United States
United States, Connecticut
Research Site
Farmington, Connecticut, United States
United States, Florida
Clearwater, Florida, United States
Melbourne, Florida, United States
Vero Beach, Florida, United States
United States, Georgia
Augusta, Georgia, United States
United States, Indiana
Indianapolis, Indiana, United States
Jeffersonville, Indiana, United States
United States, Kentucky
Edgewood, Kentucky, United States
United States, Louisiana
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
United States, Maine
Auburn, Maine, United States
United States, Maryland
Baltimore, Maryland, United States
Salisbury, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Missouri
St. Charles, Missouri, United States
St. Louis, Missouri, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Bronx, New York, United States
Buffalo, New York, United States
E. Syracuse, New York, United States
New York, New York, United States
Rochester, New York, United States
Williamsville, New York, United States
United States, North Carolina
Burlington, North Carolina, United States
United States, Ohio
Columbus, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Flourtown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, Rhode Island
Lincoln, Rhode Island, United States
Wakefield, Rhode Island, United States
United States, Texas
Tyler, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Chesapeake, Virginia, United States
Roanoke, Virginia, United States
United States, Wisconsin
Green Bay, Wisconsin, United States
Sponsors and Collaborators
AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00038077    
Other Study ID Numbers: 276
USMET0002
First Posted: May 29, 2002    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: November 2010
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Metoprolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action