Brief Title
Late Function After Surgery for Transposition of the Great Arteries
Official Title
Late Function After Surgery for Transposition of the Great Arteries
Brief Summary
The investigators proposed to review the exercise tolerance, cardiac function, and quality of
life in patients born with transposition of the great arteries that have undergone surgery
with either the Mustard or Senning procedure. Participants will complete a questionnaire. The
investigators will review the participants' recent cardiac function testing which will assess
their current health status. These tests include an echocardiogram, a metabolic exercise
stress test, cardiac imaging, and a 24-hour Holter monitor. This collection of testing
results will be compared specifically with previously acquired data during the first phases
of this study (published in 2001 and 2007).
Detailed Description
1. Enrolled subjects must consent to the study and authorize release of health information.
All studies obtained as part of this research study are considered part of routine care.
2. Prior to testing, subjects must complete a questionnaire assessing quality of life. This
is the same questionnaire that has been used in the previous portions of this study.
3. The investigators will review results of cardiac imaging for all participants consisting
of a cardiac MRI or cardiac CT obtained within the last 5 years. If this data does not
exist or is outdated, participants will have a new study.
4. The investigators will review results of cardiac imaging for all participants consisting
of an echocardiogram within the last 5 years. If this data does not exist or is
outdated, participants will have a new study.
5. The investigators will review results of cardiac function testing for all participants
consisting of an exercise stress test obtained within the last 5 years. If this data
does not exist or is outdated, participants will have a new study. End criteria for the
exercise stress test includes either
a. Achieving two or more of the following: i. Heart rate of > 95% of age-predicted
maximum (using equation 220-age = maximal heart rate) ii. RER > 1.1 iii. VO2 plateau
defined as The VO2 plateau was defined as a change in VO2 during the final minute of
exercise less than 2 SD below the mean of increases between previous workloads iv. RPE >
8 on OMNI RPE scale v. Volitional exertion OR b. Achievement of any of the
contraindications to exercise testing.
6. The investigators will review results of cardiac rhythm monitoring for all participants
consisting of a 24 hour Holter monitor obtained within the last 5 years. If this data
does not exist or is outdated, participants will have a new study.
Study Type
Observational
Primary Outcome
Survival
Secondary Outcome
Quality of Life
Condition
Transposition of Great Vessels
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
45
Start Date
March 3, 2017
Completion Date
June 30, 2018
Primary Completion Date
June 30, 2018
Eligibility Criteria
Inclusion Criteria:
1. Participants must have had an atrial switch procedure (Mustard or Senning operation).
Since these operations were last performed on this population in the early 1980's all
patients will be older than 18 years of age at the time of enrollment.
2. Patients must be willing to adhere to the guidelines of this study
Exclusion Criteria:
1. Patients who are medically unstable
2. Patients that are non-ambulatory
3. Patients with a history of exercise induced arrhythmia
4. Patients with atrial flutter or history of treatment resistant atrial flutter
5. Patients who are pregnant.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03078413
Organization ID
1011003175
Responsible Party
Principal Investigator
Study Sponsor
Indiana University
Study Sponsor
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Verification Date
November 2018