Tetralogy of FallotrTOF-MR-SHARPNCT05916976
Repaired Tetralogy of Fallot: Risc Score From MRI & Clinical Data to Predict the Need for Change of Treatment
A study testing cardiac MRI in people with Tetralogy of Fallot and Congenital Heart Disease, run by University Medical Center Goettingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Tetralogy of Fallot, Congenital Heart Disease
- What is being tested?
- cardiac MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- rTOF; age above 16; eligible for MRI-exam
Who cannot join
- any contraindications to MRI; unstable patient; unresponsive patient
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Goettingen
Göttingen, Lower Saxxony, 37075
Anne M Weber, +4955139 ext. 68965, radiologie@med.uni-goettingen.de
Joachim Lotz, MD
About this study
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
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.
Read the 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
- Being tested
- cardiac MRI
- Keywords
- MRI, Tetralogy of Fallot, Multiparametric score, cardiac
- Medical subject headings
- Tetralogy of Fallot, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac MRIDiagnostic test
Multiparametric MRI of the heart
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified therapy cardiovascular
Any change in therapy related to cardiovascular function
Measured: 24 months
Secondary outcomes (2)
hospitalization
Need of hospital admission due to any cardiovascular cause
Measured: 24 months
cardiac intervention
Any cardiac invasive / minimal invasive intervention
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start15 Oct 2023 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetralogy of FallotStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- all patients scheduled for MRI for follow-up of repaired Tetralogy of Fallot.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim Lotz, University Medical Center Goettingen
- Investigators
- Joachim Lotz, MD, Study director, Institute of Diagnostic and Interventional Radiology, UMG Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916976
- Sponsor's protocol ID
- 2023-02659
- Other IDs
- 2023
- Acronym
- rTOF-MR-SHARP
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results of all successfully included patients, anonymized.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05916976
- Acronym / sponsor ID
- rTOF-MR-SHARP / 2023-02659
- Conditions
- Tetralogy of Fallot, Congenital Heart Disease
- Keywords
- MRI, Tetralogy of Fallot, Multiparametric score, cardiac
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- all patients scheduled for MRI for follow-up of repaired Tetralogy of Fallot.
| Arm | Type | Receives |
|---|---|---|
| rTOF-patients | Other | Diagnostic Test: cardiac MRIrTOF-patients with age 16 and above enrolled in Adult Congenital Heart Disease (ACHD)-outpatient clinics program with regularly scheduled MRI-exam |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- rTOF; age above 16; eligible for MRI-exam
Key exclusion criteria (1 listed)
- any contraindications to MRI; unstable patient; unresponsive patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac MRIMultiparametric MRI of the heart | Diagnostic test | rTOF-patients |
Primary outcome
Modified therapy cardiovascular
Time frame: 24 months
Any change in therapy related to cardiovascular function
2 secondary outcomes
hospitalization
Time frame: 24 months
cardiac intervention
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: Yes. Results of all successfully included patients, anonymized.
Related trials for Tetralogy of Fallot
RecruitingPhase 4
Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF)
RecruitingPhase 1
Beta-blocker Administration for Cardiomyocyte Division
Tetralogy of Fallot, Double Outlet Right Ventricle
Active, not recruiting
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
Recruiting
Investigation of Tetralogy of Fallot in Neonates
Tetralogy of Fallot (TOF), Pulmonary Stenosis
RecruitingObservational study
Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot
Tetralogy of Fallot (TOF), Congenital Heart Defects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Lotz, MD study director
Institute of Diagnostic and Interventional Radiology, UMG Göttingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac MRI in people with Tetralogy of Fallot and Congenital Heart Disease, run by University Medical Center Goettingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne M Weber (+4955139 ext. 68965, radiology@med.uni-goettingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified therapy cardiovascular (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.