| NCT ID | NCT05563376 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Erlangen-Nürnberg Medical School |
| Condition | Univentricular Heart |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2020-09-01 |
| Primary Completion | 2031-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2020-09-01 with a primary completion date of 2031-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
After successful Fontan surgery, the risk of mortality in childhood is only low. Unfortunately, some of the patients suffer from Fontan-typical long-term complications in the long-term course, whereby protein loss neuropathy must be mentioned in particular, which is described in the literature with an incidence of 3-14% (1, 2) and still has a 5-year risk of death of 6-12% today (2, 3). Protein loss tereopathy leads to loss of protein in the intestine and subsequently to diarrhea and edema. Other problems concern the liver, which can develop cirrhosis due to chronic congestion (4-6). Cardiac can lead to heart failure and arrhythmias. The registry study described in this protocol is intended to identify factors that influence the treatment outcome of patients in the Fontan circulation in the long term through systematic prospective documentation of the data from our standardized and guideline-oriented treatment.
Eligibility Criteria
Inclusion Criteria: * congenital heart defect of the univentricular type that has led to Fontan circulation Exclusion Criteria: * no exclusion criteria
Contact & Investigator
Sven Dittrich, Prof.
STUDY CHAIR
University of Erlangen-Nürnberg
Frequently Asked Questions
Who can join the NCT05563376 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 60 Years, studying Univentricular Heart. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05563376 currently recruiting?
Yes, NCT05563376 is actively recruiting participants. Contact the research team at isabelle.schoeffl@uk-erlangen.de for enrollment information.
Where is the NCT05563376 trial being conducted?
This trial is being conducted at Erlangen, Germany.
Who is sponsoring the NCT05563376 clinical trial?
NCT05563376 is sponsored by University of Erlangen-Nürnberg Medical School. The principal investigator is Sven Dittrich, Prof. at University of Erlangen-Nürnberg. The trial plans to enroll 200 participants.