Cardiac imaging for patients with Fontan circulation
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Karolinska Institutet · NCT06735521
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 |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06735521 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Stockholm
- Karolinska University Hospital — Stockholm, Sweden (RECRUITING)
Study contacts
- Study coordinator: Peder Sorensson, MD, Associate professor
- Email: peder.sorensson@ki.se
- Phone: +46 731 400059
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, Microvascular Dysfunction, Heart Failure, Magnetic Resonance, Fontan circulation, CMR, stress-perfusion, tissue characterization