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| Sponsored by: |
Children's Healthcare of Atlanta |
|---|---|
| Information provided by: | Children's Healthcare of Atlanta |
| ClinicalTrials.gov Identifier: | NCT00249067 |
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: | Natural History, Longitudinal, Defined Population, Retrospective Study |
| Official Title: | The Retrospective Evaluation of Carvedilol Versus Captopril and Digoxin/Lasix Therapy in Congestive Heart Failure Due to Left-to-Right Shunt Lesions |
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | October 2005 |
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 |
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| United States, Georgia | |
| Children's Healthcare of Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: | Jeffrey D Dayton, MD | Resident-Emory Department of Pediatrics |
More Information
| Study ID Numbers: | 05.178 |
| Study First Received: | November 4, 2005 |
| Last Updated: | June 12, 2007 |
| ClinicalTrials.gov Identifier: | NCT00249067 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Congestive Heart Failure, Left-to-Right Shunt |
|
Captopril Signs and Symptoms Heart Failure Heart Diseases |
Heart Murmurs Digoxin Furosemide Carvedilol |
|
Signs and Symptoms Heart Failure Heart Diseases Heart Murmurs Cardiovascular Diseases |
