Retrospective Evaluation of Carvedilol Versus Captopril in CHF Patients

This study has been terminated.
(data collection completed)
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00249067
First received: November 4, 2005
Last updated: June 12, 2007
Last verified: June 2007
  Purpose

This is a retrospective chart review examining our experience with carvedilol in CHF secondary to left-to-right heart shunt lesions. The treatment group will be children who have received carvedilol. The control or comparison groups will be patients who have received either digoxin/furosemide or captopril for this indication. Charts will be reviewed of patients who have been treated at Children’s Healthcare of Atlanta and as outpatients by Sibley Heart Center Cardiology between September 2000 and October 2005. Patients will have been started on carvedilol prior to April 1, 2005 and only information up to October 1, 2005 will be used for this study. We will review approximately 50 charts for this study.

We will evaluate the effectiveness of these medications at reducing symptoms of CHF.


Condition
Heart Failure
Heart Murmurs

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: The Retrospective Evaluation of Carvedilol Versus Captopril and Digoxin/Lasix Therapy in Congestive Heart Failure Due to Left-to-Right Shunt Lesions

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Estimated Enrollment: 50
Study Start Date: October 2005
Estimated Study Completion Date: October 2005
Detailed Description:

This is a retrospective chart review examining our experience with carvedilol in CHF secondary to left-to-right heart shunt lesions. The treatment group will be children who have received carvedilol. The control or comparison groups will be patients who have received either digoxin/furosemide or captopril for this indication. Charts will be reviewed of patients who have been treated at Children’s Healthcare of Atlanta and as outpatients by Sibley Heart Center Cardiology between September 2000 and October 2005. Patients will have been started on carvedilol prior to April 1, 2005 and only information up to October 1, 2005 will be used for this study. We will review approximately 50 charts for this study.

We will evaluate the effectiveness of these medications at reducing symptoms of CHF.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Children aged 0-18 years with a cardiac defect resulting in a left-to-right shunt (i.e. ventricular septal defect) who develop congestive heart failure. Patient must have been treated with one of the study medications: carvedilol, digoxin, or furosemide.

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Exclusion Criteria: Patients who are not between 0-18, who do not have a defect resulting in left-to-right shunt, who do not have congestive heart failure and who have not been treated with one of the study medications: carvedilol, digoxin, or furosemide.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249067

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Jeffrey D Dayton, MD Resident-Emory Department of Pediatrics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00249067     History of Changes
Other Study ID Numbers: 05.178
Study First Received: November 4, 2005
Last Updated: June 12, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Healthcare of Atlanta:
Congestive Heart Failure, Left-to-Right Shunt

Additional relevant MeSH terms:
Heart Failure
Heart Murmurs
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms
Captopril
Carvedilol
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on August 27, 2014