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

Sponsored by:	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: Toprol-XL 50 mg Drug: Toprol-XL 200 mg Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

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
Estimated Study Completion Date:	September 2003

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 National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	276, USMET0002
Study First Received:	May 28, 2002
Last Updated:	June 10, 2009
ClinicalTrials.gov Identifier:	NCT00038077 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Heart Failure
Heart Diseases
Adrenergic Agents
Metoprolol succinate
Adrenergic beta-Antagonists

Adrenergic Antagonists
Peripheral Nervous System Agents
Cardiovascular Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Metoprolol

Additional relevant MeSH terms:

Sympatholytics
Heart Failure
Neurotransmitter Agents
Heart Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Metoprolol

Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Metoprolol succinate
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Peripheral Nervous System Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on September 11, 2009