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Sponsored by: |
Emory University |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00313352 |
The purpose of this chart review study is to examine the effects of -adrenergic blocking agents on systemic ventricular dimensions, systemic atrioventricular valve function and exercise tolerance in patients with transposition of the great arteries (TGA) and systemic ventricular dysfunction.
Condition |
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Congenital Disorders |
Study Type: | Observational |
Study Design: | Natural History, Longitudinal, Defined Population, Retrospective Study |
Official Title: | Effects of Beta-Adrenergic Blocking Agents in Adult Patients With Transposition of the Great Arteries on Systemic Ventricular Function |
Estimated Enrollment: | 110 |
Study Start Date: | January 1997 |
Many children with transposition of the great arteries who underwent atrial inflow correction using the Mustard or Senning operation are now adults.
While their short- and midterm prognosis have been good, their life expectancy is limited by the onset of serious cardiovascular complications including arrhythmias, systemic (morphologically right) ventricular dysfunction and sudden cardiac death.
The ability of the morphological right ventricle (RV) to support the systemic circulation is limited. It has been postulated that perfusion and wall motion abnormalities are common in the systemic RV late (10-20 years) after Mustard’s operation. Poor ventricular function causes progressive RV enlargement and systemic atrioventricular valve insufficiency, resulting in congestive heart failure (CHF). Deterioration in systolic function of the systemic ventricle is a major determinant of survival in these patients.
Little is known about the most effective therapy of progressive systemic RV dysfunction in these patients. Despite several recent studies demonstrating the benefit of -adrenergic blocking agents in improved left ventricular function in adults with heart failure and left ventricular dysfunction, there have been no reports of the use of -adrenergic blocking agents in adult patients with ventricular dysfunction due to congenital heart disease. This data collection study will be a single center, retrospective study; a chart review of patients with TGA (either DTGA or LTGA) and systemic right ventricular dysfunction.
Patient Population:
Patients followed-up at Emory University Hospital and The Emory Clinic who meet the following inclusion criteria:
Future Directions:
The effects of -adrenergic blocking agents in patients with TGA and congestive heart failure due to systemic ventricular dysfunction have never been studied. To our knowledge, only one case report suggests that carvedilol may potentially improve systemic ventricular functions and volumes in these patients. This study will identify the potential merits of -blocker therapy in patients with TGA and CHF and could theoretically lead to a multi-institutional prospective analysis of -blocker therapy in adult patients with congenial heart disease and CHF.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients followed-up at Emory University Hospital and The Emory Clinic who meet the following inclusion criteria:
Exclusion Criteria:
Study ID Numbers: | 293-2006 |
Study First Received: | April 10, 2006 |
Last Updated: | April 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00313352 History of Changes |
Health Authority: | United States: Food and Drug Administration |
adult cardiac transposition of great arteries beta-adrenergic blockers |
Great Vessels Transposition Neurotransmitter Agents Heart Diseases Adrenergic Agents Cardiovascular Abnormalities Transposition of Great Vessels |
Adrenergic beta-Antagonists Adrenergic Antagonists Congenital Abnormalities Heart Defects, Congenital Transposition of Great Arteries |
Neurotransmitter Agents Heart Diseases Cardiovascular Abnormalities Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Pharmacologic Actions |
Transposition of Great Vessels Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Congenital Abnormalities Heart Defects, Congenital |