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

This study has been completed.
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00004854
First received: March 8, 2000
Last updated: June 23, 2005
Last verified: December 2003
History of Changes
  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.


Condition Intervention Phase
Heart Diseases
 Drug: Carvedilol
 Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic

Resource links provided by NLM:

Drug Information available for: Carvedilol
U.S. FDA Resources

Further study details as provided by National Center for Research Resources (NCRR):

  Eligibility

Ages Eligible for Study:   3 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004854

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
National Center for Research Resources (NCRR)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004854     History of Changes
Other Study ID Numbers: NCRR-M01RR00036-5073, M01RR00036
Study First Received: March 8, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):
moderate heart failure

Additional relevant MeSH terms:
Heart Diseases
Heart Failure
Cardiovascular Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on May 23, 2013