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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tetralogy of Fallot; Congenital Heart Disease
• Intervention / Treatment: Diagnostic test: cardiac MRI

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne M Weber; Phone Number: 68965 +4955139; Email: radiology@med.uni-goettingen.de
• Study Contact Backup: Name: Claudia Dellas, MD; Phone Number: 66714 +4955139; Email: dellas@med.uni-goettingen.de

Study Locations

• Germany
  • Lower Saxxony
    • Göttingen, Lower Saxxony, Germany, 37075
      • University Medical Center Goettingen
      • Contact: Anne M Weber; Phone Number: 68965 +4955139; Email: radiologie@med.uni-goettingen.de
      • Principal Investigator: Joachim Lotz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• any contraindications to MRI; unstable patient; unresponsive patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified therapy cardiovascular	Any change in therapy related to cardiovascular function	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospitalization	Need of hospital admission due to any cardiovascular cause	24 months
cardiac intervention	Any cardiac invasive / minimal invasive intervention	24 months

Collaborators and Investigators

• Sponsor: University Medical Center Goettingen
• Investigators: Study Director: Joachim Lotz, MD, Institute of Diagnostic and Interventional Radiology, UMG Göttingen

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2023
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: MRI; cardiac; Tetralogy of Fallot; Multiparametric score
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Tetralogy of Fallot; Heart Defects, Congenital
• Other Study ID Numbers: 2023-02659

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Results of all successfully included patients, anonymized.
• IPD Sharing Time Frame: After completion of study and publication of results. probably 2026
• IPD Sharing Access Criteria: Access granted upon qualified request. Data will be made available through the RACOON Network of the Network of University Medicine Germany (NUM-Project) as well as the German Center of Cardiovascular Research (DZHK)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No