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NCT00004854 Clinical Trial

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

Heart Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004854
Other study ID # NCRR-M01RR00036-5073
Secondary ID M01RR000036
Status Completed
Phase Phase 1
First received March 8, 2000
Last updated June 23, 2005

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 17 Years
Eligibility 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

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Carvedilol

Locations
Country Name City State
United States Washington University School of Medicine St. Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

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