Clinical trialNCT00052026CompletedPhase 3Interventional

Safety and Efficacy Study of Carvedilol to Treat Children With Congestive Heart Failure

SponsorShaddy, Robert, M.D.Enrollment161Congestive Heart Failure

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to determine whether a new medicine, called carvedilol, improves symptoms and heart function in children who have congestive heart failure (diminished function of their heart muscle that pumps blood to the body). To accomplish this, we will give carvedilol to some patients who have diminished heart function and congestive heart failure and see whether symptoms and heart function are better at the end of an 8 month period in those who received carvedilol compared to the other patients who did not receive carvedilol. We will be testing 2 different doses of carvedilol compared to no additional medicine.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Robert E. Shaddy, MD
University of Utah
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

21 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama
Birmingham, Alabama, United States
Children'S Hospital Los Angeles
Los Angeles, California, United States
Mattel Children'S Hospital at Ucla
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of Colorado
Denver, Colorado, United States
University of Miami
Miami, Florida, United States
University of Southern Florida
St. Petersburg, Florida, United States
Children'S Memorial Hospital
Chicago, Illinois, United States
Children'S Hospital, Boston
Boston, Massachusetts, United States
C.S. Mott Children'S Hospital
Ann Arbor, Michigan, United States
Children'S Hospital of Michigan
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
Columbia University
New York, New York, United States
Nyu Medical Center
New York, New York, United States
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children'S Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt Children'S Hospital
Nashville, Tennessee, United States
Ut Southwestern Medical Center
Dallas, Texas, United States
Texas Children'S Hospital
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Seattle Childrens Hospital and Regional Medical Center
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Carvedilol →Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 May 2000
Primary completion: 30 Jun 2005
Completion: 31 Jul 2006
Last update posted: 25 Dec 2008
Registered enrollment: 161
Registry id: NCT00052026

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.