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

NCT ID: NCT05916976

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-15
• Study Completion Date: 2026-04-30

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.

Conditions

Tetralogy of Fallot; Congenital Heart Disease

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

rTOF-patients

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

Group Type: OTHER

cardiac MRI

Intervention Type: DIAGNOSTIC_TEST

Multiparametric MRI of the heart

Interventions

cardiac MRI

Multiparametric MRI of the heart

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• any contraindications to MRI; unstable patient; unresponsive patient

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Goettingen

OTHER

Sponsor Role: lead

Responsible Party

Joachim Lotz

Professor of Radiology; Director Institute of Diagnostic and Interventional Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joachim Lotz, MD

Role: STUDY_DIRECTOR

Institute of Diagnostic and Interventional Radiology, UMG Göttingen

Locations

University Medical Center Goettingen

Göttingen, Lower Saxxony, Germany

Countries

Germany

Central Contacts

Anne M Weber

Role: CONTACT

radiology@med.uni-goettingen.de

+4955139 ext. 68965

Claudia Dellas, MD

Role: CONTACT

dellas@med.uni-goettingen.de

+4955139 ext. 66714

Facility Contacts

Anne M Weber

Role: primary

radiologie@med.uni-goettingen.de

+4955139 ext. 68965

Other Identifiers

2023-02659

Identifier Type: -

Identifier Source: org_study_id