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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Diseases

Keywords

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moderate heart failure

Study Design

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Primary Study Purpose

DIAGNOSTIC

Interventions

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Carvedilol

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

3 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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M01RR000036

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCRR-M01RR00036-5073

Identifier Type: -

Identifier Source: org_study_id