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

NCT05916976 | Not Yet Recruiting

• 1 other identifier: 2023-02659
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Tetralogy of Fallot; Congenital Heart Disease

Keywords

MRI; Tetralogy of Fallot; Multiparametric score; cardiac

Outcome Measures

Primary Outcomes (1)

• Modified therapy cardiovascular

  Any change in therapy related to cardiovascular function

  24 months

Secondary Outcomes (2)

• hospitalization

  24 months

• cardiac intervention

  24 months

Study Arms (1)

rTOF-patients

OTHER

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

Interventions

cardiac MRI DIAGNOSTIC_TEST

Multiparametric MRI of the heart

rTOF-patients

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• any contraindications to MRI; unstable patient; unresponsive patient

Sponsors & Collaborators

• University Medical Center Goettingen: lead

Study Sites (1)

University Medical Center Goettingen

Göttingen, Lower Saxxony, 37075, Germany

Location

MeSH Terms

Conditions

Tetralogy of Fallot; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Joachim Lotz, MD

  Institute of Diagnostic and Interventional Radiology, UMG Göttingen

  STUDY DIRECTOR

Central Study Contacts

Anne M Weber

CONTACT

+4955139; radiology@med.uni-goettingen.de

Claudia Dellas, MD

CONTACT

+4955139; dellas@med.uni-goettingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology; Director Institute of Diagnostic and Interventional Radiology

Model Details: all patients scheduled for MRI for follow-up of repaired Tetralogy of Fallot.

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: October 15, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After completion of study and publication of results. probably 2026
• 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)

Locations

DE (1)