Long-term outcomes for patients with univentricular hearts after Fontan surgery
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
NA · University of Erlangen-Nürnberg Medical School · NCT05563376
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 6 Years to 60 Years |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School (other) |
| Locations | 1 site (Erlangen) |
| Trial ID | NCT05563376 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with congenital heart defects of the univentricular type who have undergone Fontan surgery.
Not a fit: Patients with heart conditions other than univentricular defects may not benefit from this study.
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 performed: Other studies have shown success in understanding long-term complications in similar patient populations, indicating that this approach is both relevant and necessary.
Eligibility criteria
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 this trial is running
Erlangen
- Universitätsklinikum — Erlangen, Germany (RECRUITING)
Study contacts
- Study coordinator: Isabelle Schöffl, PD
- Email: isabelle.schoeffl@uk-erlangen.de
- Phone: 09131 85 33750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Univentricular Heart