Long-term outcomes for patients with univentricular hearts after Fontan surgery
Official title: Prospektive Erfassung Von standardmäßig Erhobenen Daten im Rahmen Der Erlanger Fontan-Sprechstunde Zur Behandlung Und Überwachung Von PatientInnen Mit univentrikulärem Herzfehler im Sinne Einer Fontan-Zirkulation
Run by University of Erlangen-Nürnberg Medical School · NCT05563376 · Data updated 2026-11-12
This study looks at how people with univentricular hearts do over the long term after Fontan surgery, focusing on their heart health, liver and kidney function, and overall well-being.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 60 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Locations | 1 site (Erlangen) |
| Status | Recruiting |
| Started | September 1, 2020 |
| Main results expected | September 1, 2031 |
| Study ends | September 1, 2041 |
| Registry record updated | October 3, 2022 |
| Trial ID | NCT05563376 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with congenital heart defects of the univentricular type who have undergone Fontan surgery.
✕Probably not a fit
Patients with heart conditions other than univentricular defects may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to systematically document and analyze long-term outcomes in patients who have undergone Fontan surgery for univentricular heart defects. It will investigate various factors influencing treatment outcomes, including lymphatic drainage disorders, immunological changes, and psychological and social development. The study will also assess liver and kidney health, cardiac function, and the impact of physical activity and early interventions on complications. Data will be collected through routine clinical assessments and standardized questionnaires over multiple time points.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies and better long-term health outcomes for patients with univentricular hearts.
How similar studies have gone: Other studies have shown success in understanding long-term complications in similar patient populations, indicating that this approach is both relevant and necessary.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * congenital heart defect of the univentricular type that has led to Fontan circulation Exclusion Criteria: * no exclusion criteria
Where it's running
-
Universitätsklinikum
Erlangen, Germany Recruiting
Study contacts
- Study coordinator: Isabelle Schöffl, PD
- Email: isabelle.schoeffl@uk-erlangen.de
- Phone: 09131 85 33750
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Fontan outcomes with low versus high lung blood flow in single‑ventricle hearts
This project will test whether people with single‑ventricle congenital heart disease who have reduced versus increased pulmonary blood flow do better or worse after the Fontan operation.
-
Cardiac imaging for patients with Fontan circulation
This study is testing if special heart scans can help find early heart problems in patients who have had Fontan surgery for univentricular heart conditions, so they can get treatment before things get worse.
-
Using lab-grown heart cells to treat congenital heart disease
This study is testing if using heart cells made from patients' own skin can safely help people with congenital heart disease feel better.
-
Evaluation of treatment for univentricular heart defects
This study is testing a new treatment approach for children with univentricular heart defects to see if it can improve their care and lower the risk of death.
-
Registry to evaluate the safety of a new venous cannula for patients with heart failure
This study is testing the safety of a new venous cannula for patients with heart failure who are using a special heart pump to see how well it works and if it has any risks.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.