Reversal of Ventricular Remodeling With Toprol-XL

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00038077

First received: May 28, 2002

Last updated: November 17, 2010

Last verified: November 2010

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

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

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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 44 Study Locations

Sponsors and Collaborators

AstraZeneca

More Information

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

Additional relevant MeSH terms:


Heart Failure Ventricular Remodeling Heart Diseases Cardiovascular Diseases Pathological Conditions, Anatomical Metoprolol Anti-Arrhythmia Agents 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 September 21, 2017

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