Reversal of Ventricular Remodeling With Toprol-XL

November 17, 2010 updated by: AstraZeneca
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 3

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
    • Alabama
      • Birmingham, Alabama, United States
      • Mobile, Alabama, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Los Angeles, California, United States
      • Northridge, California, United States
      • Redondo Beach, California, United States
      • Riverside, California, United States
    • Connecticut
      • Farmington, Connecticut, United States
        • Research Site
    • Florida
      • Clearwater, Florida, United States
      • Melbourne, Florida, United States
      • Vero Beach, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
    • Indiana
      • Indianapolis, Indiana, United States
      • Jeffersonville, Indiana, United States
    • Kentucky
      • Edgewood, Kentucky, United States
    • Louisiana
      • New Orleans, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maine
      • Auburn, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Salisbury, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Missouri
      • St. Charles, Missouri, United States
      • St. Louis, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New Mexico
      • Albuquerque, New Mexico, 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
    • North Carolina
      • Burlington, North Carolina, United States
    • Ohio
      • Columbus, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Flourtown, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Rhode Island
      • Lincoln, Rhode Island, United States
      • Wakefield, Rhode Island, United States
    • Texas
      • Tyler, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Chesapeake, Virginia, United States
      • Roanoke, Virginia, United States
    • Wisconsin
      • Green Bay, Wisconsin, United States

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:

  • 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.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Masking: DOUBLE

Collaborators and Investigators

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

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2001

Primary Completion (ACTUAL)

September 1, 2003

Study Completion (ACTUAL)

September 1, 2003

Study Registration Dates

First Submitted

May 28, 2002

First Submitted That Met QC Criteria

May 28, 2002

First Posted (ESTIMATE)

May 29, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

November 19, 2010

Last Update Submitted That Met QC Criteria

November 17, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 276
  • USMET0002

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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