Reversal of Ventricular Remodeling With Toprol-XL

Condition(s) targeted: Heart Failure, Congestive

Intervention: Toprol-XL 50 mg (Drug); Toprol-XL 200 mg (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored 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 design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Birmingham, Alabama, United States

Mobile, Alabama, United States

Little Rock, Arkansas, United States

Riverside, California, United States

Redondo Beach, California, United States

Los Angeles, California, United States

Northridge, California, United States

Research Site, Farmington, Connecticut, United States

Vero Beach, Florida, United States

Melbourne, Florida, United States

Clearwater, Florida, United States

Augusta, Georgia, United States

Jeffersonville, Indiana, United States

Indianapolis, Indiana, United States

Edgewood, Kentucky, United States

Shreveport, Louisiana, United States

New Orleans, Louisiana, United States

Auburn, Maine, United States

Baltimore, Maryland, United States

Salisbury, Maryland, United States

Boston, Massachusetts, United States

St. Charles, Missouri, United States

St. Louis, Missouri, United States

Omaha, Nebraska, United States

Albuquerque, New Mexico, United States

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

Burlington, North Carolina, United States

Columbus, Ohio, United States

Oklahoma City, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Flourtown, Pennsylvania, United States

Lincoln, Rhode Island, United States

Wakefield, Rhode Island, United States

Tyler, Texas, United States

Salt Lake City, Utah, United States

Roanoke, Virginia, United States

Chesapeake, Virginia, United States

Green Bay, Wisconsin, United States

Starting date: August 2001
Ending date: September 2003
Last updated: June 23, 2005