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

• Sponsor: University Medical Center Goettingen (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05916976
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 30.5
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tetralogy of Fallot; Congenital Heart Disease	Diagnostic Test: cardiac MRI	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Intervention Model Description: all patients scheduled for MRI for follow-up of repaired Tetralogy of Fallot.all patients scheduled for MRI for follow-up of repaired Tetralogy of Fallot.
• Masking: None (Open Label)
• Masking Description: MRI data are made available for clinical decision. Score will not be made available to treatment decision team. Nor is the study team involved in the clinical decision process until completion of follow-up data acquisition
• Primary Purpose: Diagnostic
• 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
• Anticipated Study Start Date: Oct 15, 2023
• Anticipated Primary Completion Date: Apr 30, 2026
• Anticipated Study Completion Date: Apr 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: rTOF-patients rTOF-patients with age 16 and above enrolled in Adult Congenital Heart Disease (ACHD)-outpatient clinics program with regularly scheduled MRI-exam	Diagnostic Test: cardiac MRI; Multiparametric MRI of the heart

Outcome Measures

Primary Outcome Measures

1. Modified therapy cardiovascular [24 months]

   Any change in therapy related to cardiovascular function

Secondary Outcome Measures

1. hospitalization [24 months]

   Need of hospital admission due to any cardiovascular cause

2. cardiac intervention [24 months]

   Any cardiac invasive / minimal invasive intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• any contraindications to MRI; unstable patient; unresponsive patient

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Goettingen	Göttingen	Lower Saxxony	Germany	37075

Sponsors and Collaborators

• University Medical Center Goettingen

Investigators

• Study Director: Joachim Lotz, MD, Institute of Diagnostic and Interventional Radiology, UMG Göttingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joachim Lotz, Professor of Radiology; Director Institute of Diagnostic and Interventional Radiology, University Medical Center Goettingen
• ClinicalTrials.gov Identifier: NCT05916976
• Other Study ID Numbers: 2023-02659
• First Posted: Jun 23, 2023
• Last Update Posted: Jun 23, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Joachim Lotz, Professor of Radiology; Director Institute of Diagnostic and Interventional Radiology, University Medical Center Goettingen: MRI; Tetralogy of Fallot; Multiparametric score; cardiac
• Additional relevant MeSH terms: Heart Diseases; Heart Defects, Congenital; Tetralogy of Fallot

Study Results

No Results Posted as of Jun 23, 2023