Clinical trial Recruiting at 1 site Observational Ages 18 and up

Cardiac imaging for patients with Fontan circulation

Official title: Att Överleva Och Leva Som Vuxen Med Enkammarhjärta I Sverige

Run by Karolinska Institutet · NCT06735521 · Data updated 2026-11-12

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.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment30 (estimated)
SponsorKarolinska Institutet
Academic / other
Drugs / interventionsradiation
Locations1 site (Stockholm)
StatusRecruiting
StartedApril 15, 2024
Main results expectedJune 30, 2025
Study endsSeptember 1, 2025
Registry record updatedDecember 16, 2024
Trial IDNCT06735521 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults over 18 years old who have undergone total cavo-pulmonary connection surgery and are classified as NYHA class I-II.

Probably not a fit

Patients with advanced heart failure (NYHA class III-IV), significant kidney failure, or those with arrhythmias 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 observational study utilizes cardiac magnetic resonance (CMR) imaging to assess patients with univentricular heart conditions who have undergone Fontan surgery. The study aims to detect early signs of cardiac dysfunction and microvascular issues through advanced non-invasive imaging techniques, allowing for timely intervention before symptoms worsen. Participants will undergo CMR scans with specific imaging protocols and contrast agents to create detailed myocardial stress-perfusion maps. The goal is to improve clinical decision-making regarding treatment and monitoring of these patients.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection and treatment of cardiac issues in patients with Fontan circulation, potentially improving their long-term health outcomes.

How similar studies have gone: While there is limited data on this specific approach, CMR imaging has shown promise in other studies involving adult congenital heart disease, suggesting potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients who had undergone total cavo-pulmonary connection (TCPC) surgery resulting in Fontan circulation.
* NYHA (New York Heart Assosiation) class I-II.
* Understanding the study information (signed informed consent).
* \>18 years old.

Exclusion Criteria:

* Device therapy (pacemaker, ICD).
* Failing Fontan (NYHA III-IV).
* Kidney failure (GFR\<30ml/h).
* Arrythmia (atrial fibrillation).
* Pregnancy.

Where it's running

  • Karolinska University Hospital
    Stockholm, Sweden
    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.