Mangafodipir - an Intracellular Contrast Agent for Magnetic Resonance Imaging (MRI): Measuring Ma… (NCT06731738) | Clinical Trial Compass
CompletedPhase 2
Mangafodipir - an Intracellular Contrast Agent for Magnetic Resonance Imaging (MRI): Measuring Manganese Uptake Rate in Heart Failure Patients With Preserved Ejection Fraction (HFpEF) Patients.
Norway44 participantsStarted 2024-11-22
Plain-language summary
More than half of heart failure patients have preserved ejection fraction (HFpEF), a condition caused by increased wall stiffness that impairs proper heart filling. Two types of cardiac fibrosis, replacement fibrosis and interstitial fibrosis, contribute to this stiffening. In addition, altered calcium handling in the cardiomyocytes is relevant. The currently available contrast agents in Magnetic Resonace Imaging (MRI) primarily detect cell loss caused by replacement fibrosis, and measurements of the extracellular volume provide clues about the status of interstitial fibrosis. However, the planned trial aims to utilise mangafodipir trisodium to measure cellular function independent of the impact of fibrosis. This information could be vital for accurate diagnosis, selection and monitoring of therapy. In addition, manganese-enhanced magnetic resonance imaging (MEMRI) may be used as an alternative to examinations with gadolinium-based contrast agents in the future.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Participants who have given their signed declaration of consent and data protection declaration.
✓. Males and females (postmenopausal or surgically sterile females) aged ≥ 18 years and ≤ 90 years
✓. HFpEF (= LVEF \> 50%) with NYHA (New York Heart Association) class I, II and III and objective evidence of cardial structural and/or functional abnormalities consistent with the presence of left ventricular (LV) diastolic dysfunction/raised LV filling pressures, including raised natriuretic peptides.
✓. Patients with HCM or CA (according to current guidelines)
To quantify the manganese uptake rate after administration of mangafodipir trisodium in all segments of the left ventricular wall.
Timeframe: Images to be captured during the trial MRI examinations (up to 60 to 90 minutes after the drug administration); image evaluations shall be executed remotely.