Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

April 10, 2006
November 8, 2013
January 1997
March 2007   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00313352 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

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.

Congenital Disorders
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
March 2007
March 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00313352
0293-2006
No
Wendy M. Book, Emory University
Emory University
Not Provided
Principal Investigator: Wendy M Book, MD Emory University
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP