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Late Function After Surgery for Transposition of the Great Arteries

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ClinicalTrials.gov Identifier: NCT03078413
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Eric Ebenroth, Indiana University

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).

Condition or disease
Transposition of Great Vessels

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 If this data does not exist or is outdated, participants will have a new study.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 If this data does not exist or is outdated, participants will have a new study.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 If this data does not exist or is outdated, participants will have a new study.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

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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Late Function After Surgery for Transposition of the Great Arteries
Actual Study Start Date : March 3, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018





Primary Outcome Measures :
  1. Survival [ Time Frame: 2 years ]
    Survival following Mustard procedure to time of study


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 2 years ]
    QOL as assessed by questionnaire

  2. Exercise Capacity [ Time Frame: 2 years ]
    Peak oxygen consumption in mL/kg/min

  3. Cardiac Function [ Time Frame: 2 years ]
    RV ejection fraction (%) as measured by echocardiogram and MRI/CT

  4. Cardiac rhythm assessment [ Time Frame: 2 years ]
    Percentage of abnormal rhythm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants must have had an atrial switch procedure (Mustard or Senning operation) and have participated in the prior two installments of this study.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078413


Locations
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United States, Indiana
Indiana University Health
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Publications:
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Responsible Party: Eric Ebenroth, Clinical Associate Professor of Pediatrics, Indiana University
ClinicalTrials.gov Identifier: NCT03078413    
Other Study ID Numbers: 1011003175
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eric Ebenroth, Indiana University:
Mustard Procedure
Additional relevant MeSH terms:
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Transposition of Great Vessels
Situs Inversus
Congenital Abnormalities
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases