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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00004854
Enrollment
Unknown
Registered
2000-03-09
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

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

Conditions

Heart Diseases

Keywords

moderate heart failure

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.

Interventions

DRUGCarvedilol

Sponsors

National Center for Research Resources (NCRR)
Lead SponsorNIH

Study design

Primary purpose
DIAGNOSTIC

Eligibility

Sex/Gender
ALL
Age
3 Months to 17 Years
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

Countries

United States

Outcome results

None listed

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