Clinical trial Recruiting at 1 site Interventional Ages 6 to 60

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.

More Univentricular Heart trials

Quick facts

Study typeInterventional
Ages6 Years to 60 Years
SexAll
Enrollment200 (estimated)
SponsorUniversity of Erlangen-Nürnberg Medical School
Academic / other
Locations1 site (Erlangen)
StatusRecruiting
StartedSeptember 1, 2020
Main results expectedSeptember 1, 2031
Study endsSeptember 1, 2041
Registry record updatedOctober 3, 2022
Trial IDNCT05563376 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.