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Transposition of Great VesselsNCT03078413

Late Function After Surgery for Transposition of the Great Arteries

An observational study of Transposition of Great Vessels, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Transposition of Great Vessels
How many people
45 participants
Where
1 siteUnited States
Study dates
3 Mar 2017to 30 Jun 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana University Health

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

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).

Read the 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
  6. 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.
  7. 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.
Keywords
Mustard Procedure
Medical subject headings
Transposition of Great Vessels

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

    Survival following Mustard procedure to time of study

    Measured: 2 years

Secondary outcomes (4)

  1. Quality of Life

    QOL as assessed by questionnaire

    Measured: 2 years

  2. Exercise Capacity

    Peak oxygen consumption in mL/kg/min

    Measured: 2 years

  3. Cardiac Function

    RV ejection fraction (%) as measured by echocardiogram and MRI/CT

    Measured: 2 years

  4. Cardiac rhythm assessment

    Percentage of abnormal rhythm

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2017
  2. Study start3 Mar 2017
  3. Primary completion30 Jun 2018
  4. Study completion30 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03078413
Sponsor's protocol ID
1011003175
Status last verified
Nov 2018
First submitted
2 Mar 2017
Last updated
19 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 18851735

  • 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.

    PubMed 14966055

  • Warnes CA. Transposition of the great arteries. Circulation. 2006 Dec 12;114(24):2699-709. doi: 10.1161/CIRCULATIONAHA.105.592352.

    PubMed 17159076

  • 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.

    PubMed 15831655

  • 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.

    PubMed 11809443

Questions about this trial

What is this clinical trial studying?

An observational study of Transposition of Great Vessels, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03078413, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.

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