Expired Study
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St. Louis, Missouri 63110


Purpose:

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.


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


Study is Available At:


Original ID:

NCRR-M01RR00036-5073


NCT ID:

NCT00004854


Secondary ID:

M01RR00036


Study Acronym:


Brief Title:

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


Official Title:


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

3 Months


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Center for Research Resources (NCRR)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Diagnostic


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:December 2003
Last Changed Date:June 23, 2005
First Received Date:March 8, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Carvedilol

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Center for Research Resources (NCRR)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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