Reversal of Ventricular Remodeling With Toprol-XL - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00038077

Purpose

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.

Condition	Intervention	Phase
Heart Failure, Congestive	Drug: Seloken ZOK/Toprol-XL Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Metoprolol Metoprolol Tartrate Metoprolol succinate Metoprolol fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Estimated Enrollment:	300
Study Start Date:	August 2001
Study Completion Date:	September 2003
Primary Completion Date:	September 2003 (Final data collection date for primary outcome measure)

Intervention Details:

50 mg

Other Name: Toprol-XL

200 mg

Other Name: Toprol-XL

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038077

Show 44 Study Locations

Sponsors and Collaborators

AstraZeneca

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00038077 History of Changes
Other Study ID Numbers:	276, USMET0002
Study First Received:	May 28, 2002
Last Updated:	November 17, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Heart Failure
Ventricular Remodeling
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Metoprolol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012