NCT02588989

Active Not Recruiting

Fibrosis, Valvular and Ventricular Function in Patients With...

Universitaire Ziekenhuizen KU Leuven Source

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Other study identifiers

Sponsor study identifier

TGA_function

Study Type

observational

Actual enrollment (reported)

37

Locations

1 country

Sites

1

Timeline

Study Start

October 2015

Actual (reported)

Primary Completion

June 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

June 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: active not recruiting
Actual enrollment (reported): 37 participants
Study completion date: June 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2015
Actual (reported)
First Submitted
October 22, 2015
Actual (reported)
First Posted
October 28, 2015
Actual (reported)
Primary Completion
June 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: July 3, 2024
Status Verified: July 2024
Last Update Submitted: 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

Sponsors & Collaborators

Universitaire Ziekenhuizen KU Leuven
Otherlead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

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

Enrollment

37 participants (actual enrollment reported by the registry).

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 2015

Actual (reported)

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Unknown

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Cardiovascular Magnetic Resonance in Adults With SysTemic Right Ventricle (STAR)

Unknown

NCT05089773

Outcomes of Transposition of the Great Arteries After Arterial Switch Operation

Completed

NCT01916499

MRI Study After Arterial Switch Operation in Patients With Transposition of the Great Arteries

Completed

NCT03661385

Nitric Oxide During Bypass for Arterial Switch Operation

Phase 3Completed

NCT00703352

Eplerenone in Systemic Right Ventricle

Phase 4Completed

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.

Primary Completion

June 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

June 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

July 3, 2024

Record last verified: 2024-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02588989
Data provider: ClinicalTrials.gov
Source updated: 2024-07-03
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:01 UTC

Locations

BE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

transposition of the great arteries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations