NCT00313352

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 1997

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1997

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

10.2 years

First QC Date

April 10, 2006

Last Update Submit

November 8, 2013

Conditions

Congenital Disorders

Keywords

adultcardiactransposition of great arteriesbeta-adrenergic blockers

Outcome Measures

Primary Outcomes (1)

  • functional class

    beta blockers improved functional class in patient's with transposition and systemic right ventricles

    6 months to 5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesTransposition of Great Vessels

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital Abnormalities

Study Officials

  • Wendy M Book, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 10, 2006

First Posted

April 12, 2006

Study Start

January 1, 1997

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

US(1)