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

Effects of Beta-adrenergic Blocking Agents in Adult Patients With Transposition of the Great Arteries on Systemic Ventricular Function

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.

Study Overview

• Status: Completed
• Conditions: Congenital Disorders

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.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional class	beta blockers improved functional class in patient's with transposition and systemic right ventricles	6 months to 5 years

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Wendy M Book, MD, Emory University

Study record dates

Study Major Dates

• Study Start: January 1, 1997
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: April 10, 2006
• First Submitted That Met QC Criteria: April 10, 2006
• First Posted (Estimate): April 12, 2006

Study Record Updates

• Last Update Posted (Estimate): November 13, 2013
• Last Update Submitted That Met QC Criteria: November 8, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: adult; cardiac; transposition of great arteries; beta-adrenergic blockers
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Transposition of Great Vessels
• Other Study ID Numbers: 0293-2006