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

This study has been completed.
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00004854
First received: March 8, 2000
Last updated: June 23, 2005
Last verified: December 2003

March 8, 2000
June 23, 2005
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Complete list of historical versions of study NCT00004854 on ClinicalTrials.gov Archive Site
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The Safety and Efficacy of Adjunct Carvedilol in Children With Moderate Heart Failure
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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.

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Interventional
Phase 1
Primary Purpose: Diagnostic
Heart Diseases
Drug: Carvedilol
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
3 Months to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004854
NCRR-M01RR00036-5073, M01RR00036
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National Center for Research Resources (NCRR)
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National Center for Research Resources (NCRR)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP