NCT00038077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2001

Geographic Reach
1 country

44 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 29, 2002

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

November 19, 2010

Status Verified

November 1, 2010

Enrollment Period

2.1 years

First QC Date

May 28, 2002

Last Update Submit

November 17, 2010

Conditions

Interventions

50 mg

Also known as: Toprol-XL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (44)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Mobile, Alabama, United States

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Little Rock, Arkansas, United States

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Unknown Facility

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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Unknown Facility

Riverside, California, United States

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Research Site

Farmington, Connecticut, United States

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Unknown Facility

Clearwater, Florida, United States

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Unknown Facility

Melbourne, Florida, United States

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Unknown Facility

Vero Beach, Florida, United States

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Unknown Facility

Augusta, Georgia, United States

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Unknown Facility

Indianapolis, Indiana, United States

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Unknown Facility

Jeffersonville, Indiana, United States

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Unknown Facility

Edgewood, Kentucky, United States

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Unknown Facility

New Orleans, Louisiana, United States

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Unknown Facility

Shreveport, Louisiana, United States

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Unknown Facility

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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Unknown Facility

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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Unknown Facility

Salt Lake City, Utah, United States

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Unknown Facility

Chesapeake, Virginia, United States

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Unknown Facility

Roanoke, Virginia, United States

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Unknown Facility

Green Bay, Wisconsin, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Heart Failure

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 28, 2002

First Posted

May 29, 2002

Study Start

August 1, 2001

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

November 19, 2010

Record last verified: 2010-11

Locations