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Clinical Trials in Sweden / NCT06735521
Recruiting Observational

Cardiac Magnetic Resonance Stress-perfusion Study in Patinets with Fontan Circulation

NCT06735521 · tracked via the Priya Life Science Sweden tracker
Phase
Observational
Started
2024-04-15
Last updated
2024-12-16

Condition(s) studied

Univentricular HeartMicrovascular DysfunctionHeart FailureMagnetic Resonance

Investigational drug(s) / intervention(s)

Cardiac magnetic resonance stress-perfusion

Cardiac magnetic resonance stress-perfusion: Included patients will be examined at the Karolinska University Hospital in a 1.5T Siemens Sola magnetic resonance camera at rest and during adenosine stress with specific CMR sequences (adenosine stress-perfusion, myocardial velocities, and tissue characterization) for non-invasive determination of macro- and microvascular dysfunction, global myocardial function, pulmonary artery pressure and scarring of the myocardium. Adenosine or Regadenoson will be used as stress medication which is according to clinical routine. Adenosine will be infused over approximately 5 minutes (110-140 μg / kg/min), Regadenoson (5 ml) will be a 10-second injection (400 μg single dosage). Intravenous gadolinium-based contrast agents will be administered, Gadovist (1 mmol/ml, gadobuterol), 0.15 mmol/kg during stress and rest.

Study summary

Univentricular heart (UVH) is a severe congenital heart disease. Accurate advanced non-invasive diagnostic methods is limited. Cardiovascular magnetic resonance (CMR) imaging has evolved as a particularly useful tool for the study of patients with adult congenital heart disease (ACHD) considering its ability to determine detailed anatomy and detect early cardiac dysfunction without the need for radiation exposure. Most of contemporary treatment recommendations are based on consensus opinions/documents and small studies from local, or national registries. Improved knowledge is needed in all these areas to facilitate clinical decisions regarding treatment, monitoring and follow-up.

This study seeks to answer if early detection of deterioration in cardiac function, venous pressure and microvascular dysfunction can identify patients before the symptoms progress and thus help to initiate early treatment. The hypothesis is that quantitative myocardial stress-perfusion maps improves the pathophysiological insight in patients with UVH.

The overall goal with this research proposal is to implement combined advanced CMR imaging for a comprehensive non-invasive mapping of functional cardiovascular behavior in patients with complex UVH disease. The outcome of this research may benefit this young adult patient population due to early detection of cardiac disease, less hospitalizations because of heart failure, and eventually decrease morbidity and mortality.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Karolinska University Hospital Stockholm Sweden Recruiting

More Karolinska Institutet trials in Sweden

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06735521 on ClinicalTrials.gov ↗ ← All trials in Sweden