Clinical trial NCT00038077: Reversal of Ventricular Remodeling With Toprol-XL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure, Congestive
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2002-05-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Northridge
country: United States
state: California
city: Redondo Beach
country: United States
state: California
city: Riverside
country: United States
state: California
city: Farmington
country: United States
facility: Research Site
state: Connecticut
city: Clearwater
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Jeffersonville
country: United States
state: Indiana
city: Edgewood
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Auburn
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Salisbury
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: St. Charles
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Albuquerque
country: United States
state: New Mexico
city: Bronx
country: United States
state: New York
city: Buffalo
country: United States
state: New York
city: E. Syracuse
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Burlington
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Flourtown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Lincoln
country: United States
state: Rhode Island
city: Wakefield
country: United States
state: Rhode Island
city: Tyler
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Chesapeake
country: United States
state: Virginia
city: Roanoke
country: United States
state: Virginia
city: Green Bay
country: United States
state: Wisconsin
Study officials:
References:
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.