Congenital Heart Disease Clinical Trial
— rTOF-MR-SHARPOfficial title:
MRI in Repaired Tetralogy of Fallot: Risc Score Derived From Multiparametric Magnetic Resonance-Imaging and Clinical Data to Sharpen the Indication for Change of Individualized Treatment
Patient with Tetralogy of Fallot need live-long surveillance after initial operative correction (rTOF). MRI is an established and important component of the standardized follow-up in this patient population. A new score will be used to summarize the multitude of MRI-based parameters into a single number. Individual modificators are assigned to the components of the score. The value of each modificatory will be determined as a result of this feasibility trial. This new compound score is designed to anticipate any deterioration of cardiac function, arrhythmias or sudden cardiac death. This feasibility study is the first step to establish this score and find initial values for the modifies that are assigned to the more than 40 biomarkers from MRI, clinical examinations and serum parameters that are included in this new score.
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | April 30, 2026 |
Est. primary completion date | April 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - rTOF; age above 16; eligible for MRI-exam Exclusion Criteria: - any contraindications to MRI; unstable patient; unresponsive patient |
Country | Name | City | State |
---|---|---|---|
Germany | University Medical Center Goettingen | Göttingen | Lower Saxxony |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Goettingen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Modified therapy cardiovascular | Any change in therapy related to cardiovascular function | 24 months | |
Secondary | hospitalization | Need of hospital admission due to any cardiovascular cause | 24 months | |
Secondary | cardiac intervention | Any cardiac invasive / minimal invasive intervention | 24 months |
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