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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Stockholm) |
| Status | Recruiting |
| Started | April 15, 2024 |
| Main results expected | June 30, 2025 |
| Study ends | September 1, 2025 |
| Registry record updated | December 16, 2024 |
| Trial ID | NCT06735521 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
- Study coordinator: Peder Sorensson, MD, Associate professor
- Email: peder.sorensson@ki.se
- Phone: +46 731 400059
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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.