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

Not Applicable

Not yet recruiting

• Conditions: Tetralogy of Fallot; Congenital Heart Disease
• Interventions: Diagnostic Test: cardiac MRI

• Registration Number: NCT05916976
• Lead Sponsor: University Medical Center Goettingen

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-06-14
• Last Update Submitted: 2023-06-14
• Study First Posted: 2023-06-23
• Last Update Posted: 2023-06-23
• Study Start: 2023-10-15
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• rTOF; age above 16; eligible for MRI-exam

Exclusion Criteria

• any contraindications to MRI; unstable patient; unresponsive patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
rTOF-patients	cardiac MRI	rTOF-patients with age 16 and above enrolled in Adult Congenital Heart Disease (ACHD)-outpatient clinics program with regularly scheduled MRI-exam

Primary Outcome Measures

Name	Time	Method
Modified therapy cardiovascular	24 months	Any change in therapy related to cardiovascular function

Secondary Outcome Measures

Name	Time	Method
hospitalization	24 months	Need of hospital admission due to any cardiovascular cause
cardiac intervention	24 months	Any cardiac invasive / minimal invasive intervention

Trial Locations

Locations (1)

University Medical Center Goettingen; 🇩🇪 Göttingen, Lower Saxxony, Germany