Evaluation and Management of the Child and Adult With Fontan Circulation: A Scientific Statement From the American Heart Association.
Jack Rychik, Andrew M Atz, David S Celermajer...
https://pubmed.ncbi.nlm.nih.gov/31256636Actively Recruiting
Age: 18Years +
All Genders
ID06735521
Cardiac Magnetic Resonance Stress-perfusion Study in Adults with Fontan Circulation and Univentricular Heart
Led by Karolinska Institutet · Updated on 2024-12-16
30
Participants Needed
1
Research Sites
9 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
K
Karolinska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adults with univentricular heart (UVH), a serious congenital heart condition, to improve early detection of heart function decline and microvascular problems before symptoms worsen. The study aims to better inform treatment, monitoring, and follow-up using advanced cardiovascular magnetic resonance (CMR) imaging, which is a non-invasive method that provides detailed heart anatomy and function without radiation. The goal is to help young adults with UVH by potentially reducing hospital stays and improving health outcomes. The study uses a 1.5 Tesla Siemens magnet for CMR imaging while patients lie down. Imaging includes various scans and a blood test before the procedure. Participants receive an intravenous contrast agent and undergo stress testing with adenosine or regadenoson to evaluate heart blood flow and function. The imaging captures detailed heart motion and tissue characteristics under stress and rest conditions. Participants avoid caffeine for 24 hours before imaging. During the study, participants undergo imaging and blood tests to assess heart function, venous pressure, and microvascular health. Researchers will measure outcomes such as the detection of microvascular dysfunction and tissue characteristics over about one year. The study collects detailed data to understand heart behavior in these patients, aiming to support early treatment decisions and improve care management.
CONDITIONS
Brief Title
Cardiac Magnetic Resonance Stress-perfusion Study in Patinets with Fontan Circulation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients who had undergone total cavo-pulmonary connection (TCPC) surgery resulting in Fontan circulation.
- New York Heart Association (NYHA) class I-II.
- Able to understand study information and provide signed informed consent.
- Age greater than 18 years old.
You will not qualify if you...
- Presence of device therapy such as pacemaker or implantable cardioverter defibrillator (ICD).
- Failing Fontan circulation classified as NYHA class III-IV.
- Kidney failure with glomerular filtration rate (GFR) less than 30 ml/h.
- Atrial fibrillation or other arrhythmias.
- Pregnancy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants undergo cardiac magnetic resonance imaging at rest and during adenosine stress to assess myocardial function, vascular function, and tissue characteristics using specific CMR sequences and intravenous contrast agents.
1 visit (in-person)
Long-term Monitoring
Duration - Approximately 1 year
Participants are observed to detect microvascular dysfunction and tissue characterization over the course of approximately 1 year after imaging.
Follow-up assessments as per clinical routine
Trial Site Locations
Total: 1 location
1
Karolinska University Hospital
Stockholm, Sweden, 17176
Actively Recruiting
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Research Team
P
Peder Sorensson, MD, Associate professor
A
Ayse-Gul Ozturk, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Imaging the adult with congenital heart disease: a multimodality imaging approach-position paper from the EACVI.
Giovanni Di Salvo, Owen Miller, Sonya Babu Narayan...
https://pubmed.ncbi.nlm.nih.gov/30084968Long-Term Survival After Single-Ventricle Palliation: A Swedish Nationwide Cohort Study.
Magnus Dalén, Michal Odermarsky, Petru Liuba...
https://pubmed.ncbi.nlm.nih.gov/38497454