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OpenTrials
Completed

NCT Number: NCT00004854

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

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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Key information

Age range

3 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carvedilol

Drug

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Registry information

Important dates

First posted
Mar 9, 2000
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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