Reversal of Ventricular Remodeling With Toprol-XL - Tabular View

Tracking Information
First Received Date ^ICMJE	May 28, 2002
Last Updated Date	June 10, 2009
Start Date ^ICMJE	August 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00038077 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Reversal of Ventricular Remodeling With Toprol-XL
Official Title ^ICMJE
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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Condition ^ICMJE	Heart Failure, Congestive
Intervention ^ICMJE	Drug: Toprol-XL 50 mg Drug: Toprol-XL 200 mg Drug: Placebo
Study Arms / Comparison Groups
Publications *	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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	300
Completion Date	September 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00038077
Responsible Party
Study ID Numbers ^ICMJE	276, USMET0002
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	AstraZeneca
Verification Date	June 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP