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
  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
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
  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
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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 22, 2014