NCT02588989

Brief Summary

The aim of this project is to better evaluate the systemic right ventricular (RV) function in patients with transposition of the great arteries (TGA).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
13mo left

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress91%
Oct 2015Jun 2027

Study Start

First participant enrolled

October 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
11.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

11.7 years

First QC Date

October 22, 2015

Last Update Submit

July 2, 2024

Conditions

Transposition of Great Vessels

Outcome Measures

Primary Outcomes (1)

  • Event-free survival

    Composite clinical end point

    10 years

Study Arms (1)

transposition of the great arteries

Patients with a TGA

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a transposition of the great arteries (TGA)

You may qualify if:

  • Patients with a TGA
  • Informed consent to participate. If the patient is under the age of 18, the assent of the patient and the permission of the parents to participate

You may not qualify if:

  • Previous double-switch intervention
  • Any medical contra-indication for cardiovascular magnetic resonance (CMR) imaging (e.g. pacemaker)
  • The presence of exercise-induced arrhythmia, symptomatic myocardial ischemia, a resting systolic blood pressure \> 200 mm Hg and/or diastolic blood pressure \> 110 mm Hg, New York Heart Association (NYHA) class III or IV, or non-cardiac co-morbidity that could aggravate by exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

Intracellular RNA collection from whole blood

MeSH Terms

Conditions

Transposition of Great Vessels

Condition Hierarchy (Ancestors)

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

Study Officials

  • Werner Budts, M.D., Ph.D.

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Jan Bogaert, M.D., Ph.D.

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2015

First Posted

October 28, 2015

Study Start

October 1, 2015

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations

BE(1)