Reversal of Ventricular Remodeling With Toprol-XL - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00038077

Purpose

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	Intervention	Phase
Heart Failure, Congestive	Drug: Toprol-XL 50 mg Drug: Toprol-XL 200 mg Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Metoprolol Metoprolol Tartrate Metoprolol succinate Metoprolol fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Estimated Enrollment:	300
Study Start Date:	August 2001
Estimated Study Completion Date:	September 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038077

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Locations

United States, Alabama

Birmingham, Alabama, United States

Mobile, Alabama, United States
United States, Arkansas

Little Rock, Arkansas, United States
United States, California

Riverside, California, United States

Redondo Beach, California, United States

Los Angeles, California, United States

Northridge, California, United States
United States, Connecticut
Research Site
Farmington, Connecticut, United States
United States, Florida

Vero Beach, Florida, United States

Melbourne, Florida, United States

Clearwater, Florida, United States
United States, Georgia

Augusta, Georgia, United States
United States, Indiana

Jeffersonville, Indiana, United States

Indianapolis, Indiana, United States
United States, Kentucky

Edgewood, Kentucky, United States
United States, Louisiana

Shreveport, Louisiana, United States

New Orleans, 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

Williamsville, New York, United States

New York, New York, United States

Rochester, New York, United States

E. Syracuse, New York, United States

Buffalo, 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

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Flourtown, 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

Roanoke, Virginia, United States

Chesapeake, Virginia, United States
United States, Wisconsin

Green Bay, Wisconsin, United States

Sponsors and Collaborators

AstraZeneca

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2007 Jun 18.

Study ID Numbers:	276, USMET0002
Study First Received:	May 28, 2002
Last Updated:	June 10, 2009
ClinicalTrials.gov Identifier:	NCT00038077 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sympatholytics
Heart Failure
Neurotransmitter Agents
Heart Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Metoprolol

Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Metoprolol succinate
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Peripheral Nervous System Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on November 30, 2009