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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wendy M. Book, Emory University
ClinicalTrials.gov Identifier:
NCT00313352
First received: April 10, 2006
Last updated: November 8, 2013
Last verified: November 2013
  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 Emory University:

Primary Outcome Measures:
  • functional class [ Time Frame: 6 months to 5 years ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Wendy M. Book, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00313352     History of Changes
Other Study ID Numbers: 0293-2006
Study First Received: April 10, 2006
Last Updated: November 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
adult
cardiac
transposition of great arteries
beta-adrenergic blockers

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

ClinicalTrials.gov processed this record on October 23, 2014