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| Tracking Information | |||||
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| First Received Date ICMJE | November 4, 2005 | ||||
| Last Updated Date | June 12, 2007 | ||||
| Start Date ICMJE | October 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00249067 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Retrospective Evaluation of Carvedilol Versus Captopril in CHF Patients | ||||
| Official Title ICMJE | The Retrospective Evaluation of Carvedilol Versus Captopril and Digoxin/Lasix Therapy in Congestive Heart Failure Due to Left-to-Right Shunt Lesions | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Natural History, Longitudinal, Defined Population, Retrospective Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 50 | ||||
| Completion Date | October 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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. - 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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| Gender | Both | ||||
| Ages | up to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00249067 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 05.178 | ||||
| Study Sponsor ICMJE | Children's Healthcare of Atlanta | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Children's Healthcare of Atlanta | ||||
| Verification Date | June 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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