Late Function After Surgery for Transposition of the Great Arteries

Status Completed

Clinical Trial 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).

Clinical Trial 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 If this data does not exist or is outdated, participants will have a new study.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 If this data does not exist or is outdated, participants will have a new study.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 If this data does not exist or is outdated, participants will have a new study.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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03078413
Study type	Observational
Source	Indiana University
Contact
Status	Completed
Phase
Start date	March 3, 2017
Completion date	June 30, 2018

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.