Reversal of Ventricular Remodeling With Toprol-XL

NCT ID: NCT00038077

Last Updated: 2010-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2003-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure, Congestive

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Seloken ZOK/Toprol-XL

50 mg

Intervention Type DRUG

Seloken ZOK/Toprol-XL

200 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Toprol-XL Toprol-XL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Locations

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Birmingham, Alabama, United States

Site Status

Mobile, Alabama, United States

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Little Rock, Arkansas, United States

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Los Angeles, California, United States

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Northridge, California, United States

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Redondo Beach, California, United States

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Riverside, California, United States

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Research Site

Farmington, Connecticut, United States

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Clearwater, Florida, United States

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Melbourne, Florida, United States

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Vero Beach, Florida, United States

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Augusta, Georgia, United States

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Indianapolis, Indiana, United States

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Jeffersonville, Indiana, United States

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Edgewood, Kentucky, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Auburn, Maine, United States

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Baltimore, Maryland, United States

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Salisbury, Maryland, United States

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Boston, Massachusetts, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Albuquerque, New Mexico, United States

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Buffalo, New York, United States

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East Syracuse, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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Williamsville, New York, United States

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Burlington, North Carolina, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Flourtown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Lincoln, Rhode Island, United States

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Wakefield, Rhode Island, United States

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Tyler, Texas, United States

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Salt Lake City, Utah, United States

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Chesapeake, Virginia, United States

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Roanoke, Virginia, United States

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Green Bay, Wisconsin, United States

Site Status

Countries

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United States

References

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Colucci WS, Kolias TJ, Adams KF, Armstrong WF, Ghali JK, Gottlieb SS, Greenberg B, Klibaner MI, Kukin ML, Sugg JE; REVERT Study Group. Metoprolol reverses left ventricular remodeling in patients with asymptomatic systolic dysfunction: the REversal of VEntricular Remodeling with Toprol-XL (REVERT) trial. Circulation. 2007 Jul 3;116(1):49-56. doi: 10.1161/CIRCULATIONAHA.106.666016. Epub 2007 Jun 18.

Reference Type DERIVED
PMID: 17576868 (View on PubMed)

Other Identifiers

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USMET0002

Identifier Type: -

Identifier Source: secondary_id

276

Identifier Type: -

Identifier Source: org_study_id