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Reversal of Ventricular Remodeling With Toprol-XL

Primary Purpose

Heart Failure, Congestive

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Seloken ZOK/Toprol-XL
Seloken ZOK/Toprol-XL
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 28, 2002
Last Updated
November 17, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00038077
Brief Title
Reversal of Ventricular Remodeling With Toprol-XL
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Seloken ZOK/Toprol-XL
Other Intervention Name(s)
Toprol-XL
Intervention Description
50 mg
Intervention Type
Drug
Intervention Name(s)
Seloken ZOK/Toprol-XL
Other Intervention Name(s)
Toprol-XL
Intervention Description
200 mg
Intervention Type
Drug
Intervention Name(s)
Placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
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Mobile
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Alabama
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United States
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Little Rock
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Arkansas
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United States
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Los Angeles
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California
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United States
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Northridge
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California
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United States
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Redondo Beach
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California
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United States
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Riverside
State/Province
California
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United States
Facility Name
Research Site
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Farmington
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Connecticut
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United States
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Clearwater
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Florida
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United States
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Melbourne
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Florida
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United States
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Vero Beach
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Florida
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United States
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Augusta
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Georgia
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Indianapolis
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Indiana
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United States
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Jeffersonville
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Indiana
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United States
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Edgewood
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Kentucky
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New Orleans
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Louisiana
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United States
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Shreveport
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Louisiana
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United States
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Auburn
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Maine
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United States
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Baltimore
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Maryland
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United States
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Salisbury
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United States
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Boston
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Massachusetts
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United States
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St. Charles
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Missouri
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United States
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St. Louis
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Missouri
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United States
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Omaha
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Nebraska
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United States
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Albuquerque
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New Mexico
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United States
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Bronx
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New York
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United States
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Buffalo
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New York
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United States
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E. Syracuse
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New York
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United States
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New York
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New York
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Rochester
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United States
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Williamsville
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New York
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United States
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Burlington
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North Carolina
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United States
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Columbus
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Ohio
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United States
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Oklahoma City
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Oklahoma
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United States
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Flourtown
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Pennsylvania
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United States
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Philadelphia
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United States
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Pittsburgh
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United States
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Lincoln
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Rhode Island
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United States
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Wakefield
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Rhode Island
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United States
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Tyler
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Texas
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United States
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Salt Lake City
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Utah
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United States
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Chesapeake
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Virginia
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United States
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Roanoke
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Virginia
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United States
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Green Bay
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17576868
Citation
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.
Results Reference
derived

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Reversal of Ventricular Remodeling With Toprol-XL

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