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Taking people in SwedenNo phase

Heart scan study for adults with single-chamber heart disease

Tests a heart MRI stress-perfusion scan in adults with single-ventricle heart disease.

Plain-language title generated from the registry record
Registry title: Cardiac Magnetic Resonance Stress-perfusion Study in Patinets with Fontan Circulation

Key facts

Where
Stockholm, SwedenSee the site

Where in Sweden

  • Karolinska University HospitalStockholm, SwedenTaking people

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Trial details

Who runs it
Karolinska Institutet
Trial code
NCT06735521
Record updated
16 December 2024
Original description
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.Read full original descriptionShow less

Att Överleva Och Leva Som Vuxen Med Enkammarhjärta I Sverige

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.

Inclusion: 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: Device therapy (pacemaker, ICD); Kidney failure (GFR<30ml/h); Failing Fontan (NYHA III-IV); Arrythmia (atrial fibrillation); Pregnancy.

ClinicalTrials.gov NCT06735521