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

National Center for Research Resources (NCRR)

Status and phase: Completed; Phase 1

Conditions: Heart Diseases

Treatments: Drug: Carvedilol

Study type: Interventional

Funder types: NIH

Identifiers

NCT00004854

M01RR000036 (U.S. NIH Grant/Contract)

NCRR-M01RR00036-5073

Details and patient eligibility

About

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.

Sex: All

Ages: 3 months to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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