Repaired Tetralogy of Fallot: Risc Score From MRI & Clinical Data to Predict the Need for Change of Treatment

Congenital Heart Disease Clinical Trial

— rTOF-MR-SHARP  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05916976
• Other study ID #: 2023-02659
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: June 2023
• Source: University Medical Center Goettingen
• Contact: Anne M Weber
• Phone: +4955139
• Email: radiology[@]med.uni-goettingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. Though a large number of diverse MRI-derived parameter have been shown to correlate with the incidence of major adverse cardiac events in patients with rTOF, there is not a single MRI-derived parameter that reliably predicts the incidence of heart failure, malignant arrhythmias or sudden cardiac death - the most common major adverse cardiac events in this group (rTOF-MACE). This feasibility trial is set to evaluate the feasibility of a weighted compound risk score based on about 40 parameters derived from MRI and augmented by clinical as well as serum-based biomarkers. This trial will recruit 70 consecutive patients with rTOF and correlate the new compound score with the clinical course over 2 years and the incidence of any change in therapy due to cardiac reasons. At the end of the trial each of the contributing parameters of the compound score will have been assigned a modifier based on its statistical relevance for the prediction of patient-specific rTOF-MACE or any change in cardiac related therapy. Based on this feasibility trial we aim to use the weighted compound score in a large multicenter trial to proof its applicability and relevance to short, medium and longterm prognosis of this special patient group.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Tetralogy of Fallot

Intervention

Diagnostic Test:
• cardiac MRI
Multiparametric MRI of the heart

Locations

Country	Name	City	State
Germany	University Medical Center Goettingen	Göttingen	Lower Saxxony

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

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