- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03078413
Late Function After Surgery for Transposition of the Great Arteries
Study Overview
Status
Conditions
Detailed Description
- 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.
- 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.
- 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 If this data does not exist or is outdated, participants will have a new study.
- 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 If this data does not exist or is outdated, participants will have a new study.
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 If this data does not exist or is outdated, participants will have a new study.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.
- 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 If this data does not exist or is outdated, participants will have a new study.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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
- Patients must be willing to adhere to the guidelines of this study
Exclusion Criteria:
- Patients who are medically unstable
- Patients that are non-ambulatory
- Patients with a history of exercise induced arrhythmia
- Patients with atrial flutter or history of treatment resistant atrial flutter
- Patients who are pregnant.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival
Time Frame: 2 years
|
Survival following Mustard procedure to time of study
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life
Time Frame: 2 years
|
QOL as assessed by questionnaire
|
2 years
|
Exercise Capacity
Time Frame: 2 years
|
Peak oxygen consumption in mL/kg/min
|
2 years
|
Cardiac Function
Time Frame: 2 years
|
RV ejection fraction (%) as measured by echocardiogram and MRI/CT
|
2 years
|
Cardiac rhythm assessment
Time Frame: 2 years
|
Percentage of abnormal rhythm
|
2 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Martins P, Castela E. Transposition of the great arteries. Orphanet J Rare Dis. 2008 Oct 13;3:27. doi: 10.1186/1750-1172-3-27.
- Moons P, Gewillig M, Sluysmans T, Verhaaren H, Viart P, Massin M, Suys B, Budts W, Pasquet A, De Wolf D, Vliers A. Long term outcome up to 30 years after the Mustard or Senning operation: a nationwide multicentre study in Belgium. Heart. 2004 Mar;90(3):307-13. doi: 10.1136/hrt.2002.007138.
- Warnes CA. Transposition of the great arteries. Circulation. 2006 Dec 12;114(24):2699-709. doi: 10.1161/CIRCULATIONAHA.105.592352.
- Dos L, Teruel L, Ferreira IJ, Rodriguez-Larrea J, Miro L, Girona J, Albert DC, Goncalves A, Murtra M, Casaldaliga J. Late outcome of Senning and Mustard procedures for correction of transposition of the great arteries. Heart. 2005 May;91(5):652-6. doi: 10.1136/hrt.2003.029769.
- Ebenroth ES, Hurwitz RA. Functional outcome of patients operated for d-transposition of the great arteries with the Mustard procedure. Am J Cardiol. 2002 Feb 1;89(3):353-6. doi: 10.1016/s0002-9149(01)02242-1. No abstract available.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1011003175
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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