Reversal of Ventricular Remodeling With Toprol-XL

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00038077

Enrollment

300

Registered

2002-05-29

Start date

2001-08-31

Completion date

2003-09-30

Last updated

2010-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Congestive

Brief summary

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.

Interventions

DRUGSeloken ZOK/Toprol-XL

50 mg

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026