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The Safety and Efficacy of Adjunct Carvedilol in Children With Moderate Heart Failure

Sponsor
National Center for Research Resources (NCRR) (NIH)
Overall Status
Completed
CT.gov ID
NCT00004854
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

We would like to see if using Carvedilol in adjunct with Ace inhibitors will increase ejection fraction of the heart under echo. All interpretation of data will be sent to Boston Children's Hospital to be reviewed, which is the primary research center in this study. There are 5 hospitals participating in this study. The population targeted are children with moderate heart failure and must be on Ace inhibitors at the time of enrollment. Our outcome after placing them on Carvedilol is to change their ejection fraction on echo. The patients will be seen every 1-2 weeks, while we will titrate their medication to a maintenance dose. Secondary outcome is to increase quality of life, exercise tolerance and decrease their symptom scores as noted on their questionnaires.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Primary Purpose:
Diagnostic

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Months to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Etiology of heart failure in Group 1 or Group 2

    • Moderate heart failure as evidenced by ventricular shortening fraction <= standard deviations below the mean, or ejection fraction <= 40% d) documented shortening fraction or ejection fraction that meet criteria for greater than 3 months

    • Standard medical therapy include ACE inhibitors plus or minus diuretics plus or minus digoxin; all efforts will made to maximize therapy prior to entry. Medication doses must be stable for 3 months prior to entry

    • Willingness to comply with followup testing

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University School of Medicine St. Louis Missouri United States 63110

    Sponsors and Collaborators

    • National Center for Research Resources (NCRR)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004854
    Other Study ID Numbers:
    • NCRR-M01RR00036-5073
    • M01RR000036
    First Posted:
    Mar 9, 2000
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Dec 1, 2003
    Keywords provided by , ,
    moderate heart failure
    Additional relevant MeSH terms:
    Heart Diseases
    Carvedilol

    Study Results

    No Results Posted as of Jun 24, 2005