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Effects of Beta-adrenergic in Adults w/Transposition of Great Arteries on Systemic Ventricular Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00313352
First Posted: April 12, 2006
Last Update Posted: November 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wendy M. Book, Emory University
  Purpose
The purpose of this chart review study is to examine the effects of beta -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
Congenital Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effects of Beta-adrenergic Blocking Agents in Adult Patients With Transposition of the Great Arteries on Systemic Ventricular Function

Resource links provided by NLM:


Further study details as provided by Wendy M. Book, Emory University:

Primary Outcome Measures:
  • functional class [ Time Frame: 6 months to 5 years ]
    beta blockers improved functional class in patient's with transposition and systemic right ventricles


Enrollment: 110
Study Start Date: January 1997
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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 beta-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 beta-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:

  1. Age ≥ 18 years
  2. Diagnosis: Complete d-TGA or Congenitally Corrected TGA with a systemic morphologic right ventricle
  3. Patients > 18 years of age seen at The Emory Clinic and Emory University Hospital with transposition of the great arteries
  4. Systemic ventricular ejection fraction < 50% with or without a clinical diagnosis of heart failure
  5. Echocardiogram performed between January 1, 1997and February 1, 2006

Future Directions:

The effects of beta-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 beta-blocker therapy in patients with TGA and CHF and could theoretically lead to a multi-institutional prospective analysis of beta-blocker therapy in adult patients with congenial heart disease and CHF.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A retrospective study analysis of medical records of patients age 18yrs and up, who had systemic RV dysfunction late after atrial inflow correction for d-TGA.
Criteria

Inclusion Criteria:

  • Patients followed-up at Emory University Hospital and The Emory Clinic who meet the following inclusion criteria:

    1. Age ≥ 18 years
    2. Diagnosis: Complete d-TGA or Congenitally Corrected TGA with a systemic morphologic right ventricle
    3. Patients > 18 years of age seen at The Emory Clinic and Emory University Hospital with transposition of the great arteries
    4. Systemic ventricular ejection fraction < 50% with or without a clinical diagnosis of heart failure
    5. Echocardiogram performed between January 1, 1997and February 1, 2006

Exclusion Criteria:

  • Those who do not meet inclusion criteria.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313352


Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Wendy M Book, MD Emory University
  More Information

Responsible Party: Wendy M. Book, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00313352     History of Changes
Other Study ID Numbers: 0293-2006
First Submitted: April 10, 2006
First Posted: April 12, 2006
Last Update Posted: November 13, 2013
Last Verified: November 2013

Keywords provided by Wendy M. Book, Emory University:
adult
cardiac
transposition of great arteries
beta-adrenergic blockers

Additional relevant MeSH terms:
Transposition of Great Vessels
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs