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NCT05916976: rTOF-MR-SHARP
Repaired Tetralogy of Fallot: Risc Score From MRI & Clinical Data to Predict the Need for Change of Treatment
NA trial testing cardiac MRI in Tetralogy of Fallot in 70 participants. Not yet recruiting.
30 April 2026
Quick facts
| Lead sponsor | University Medical Center Goettingen |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 70 |
| Start date | 15 October 2023 |
| Primary completion | 30 April 2026 |
| Estimated completion | 30 April 2026 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- cardiac MRI
Conditions studied
- Tetralogy of Fallot — all drugs for Tetralogy of Fallot →
- Congenital Heart Disease — all drugs for Congenital Heart Disease →
Sponsor
University Medical Center Goettingen
Who can join
16 and older, any sex, with Tetralogy of Fallot or Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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. 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05916976
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other University Medical Center Goettingen trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05916976 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Medical Center Goettingen
- Last refreshed: 23 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05916976.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing