NCT03078413

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

March 3, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

1.3 years

First QC Date

March 2, 2017

Last Update Submit

November 16, 2018

Conditions

Transposition of Great Vessels

Keywords

Mustard Procedure

Outcome Measures

Primary Outcomes (1)

  • Survival

    Survival following Mustard procedure to time of study

    2 years

Secondary Outcomes (4)

  • Quality of Life

    2 years

  • Exercise Capacity

    2 years

  • Cardiac Function

    2 years

  • Cardiac rhythm assessment

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Related Publications (5)

  • 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.

    PMID: 18851735BACKGROUND

  • 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.

    PMID: 14966055BACKGROUND

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

    PMID: 17159076BACKGROUND

  • 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.

    PMID: 15831655BACKGROUND

  • 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.

    PMID: 11809443BACKGROUND

MeSH Terms

Conditions

Transposition of Great Vessels

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor of Pediatrics

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 13, 2017

Study Start

March 3, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

November 19, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)