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Reversal of Ventricular Remodeling With Toprol-XL

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: May 28, 2002
Last updated: November 17, 2010
Last verified: November 2010
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
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

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:
    Drug: Seloken ZOK/Toprol-XL
    50 mg
    Other Name: Toprol-XL
    Drug: Seloken ZOK/Toprol-XL
    200 mg
    Other Name: Toprol-XL
    Drug: Placebo

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00038077

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  More Information

Publications automatically indexed to this study by Identifier (NCT Number): 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
Anti-Arrhythmia Agents
Antihypertensive Agents
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 processed this record on October 25, 2016