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

NCT06735521 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-12-16

No results posted yet for this 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.

Conditions

  • Univentricular Heart
  • Microvascular Dysfunction
  • Heart Failure
  • Magnetic Resonance

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2025-06-30
Completion
2025-09-01

Countries

  • Sweden

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06735521 on ClinicalTrials.gov