drugset / Trial / NCT06731738

Mangafodipir - an Intracellular Contrast Agent for Magnetic Resonance Imaging (MRI): Measuring Manganese Uptake Rate in Heart Failure Patients With Preserved Ejection Fraction (HFpEF) Patients.

NCT06731738

Phase 2 Completed 44 enrolled IC TARGETS AS
Non-randomizedParallel-groupOpen-labelDiagnostic

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.

Timeline

Start
2024-11-22
Primary completion
2025-11-29
Completion
2025-11-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Mangafodipir Diagnostic / imaging agent 5 unknown Intravenous
Background Gadoteric acid Diagnostic / imaging agent 0.2 unknown Intravenous