New MRI scan could spot hidden heart problems without gadolinium
NCT ID NCT06731738
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new MRI technique using a contrast agent called mangafodipir to measure how well heart cells take up manganese, which reflects cell function. It included 44 participants: healthy volunteers and people with heart failure with preserved ejection fraction caused by hypertrophic cardiomyopathy or cardiac amyloidosis. The goal was to see if this method can detect heart cell problems that standard MRIs miss, potentially offering a safer alternative to gadolinium-based scans.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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44 people
The number who actually took part.
- Started
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Nov 2024
- Finished
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Nov 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participants who have given their signed declaration of consent and data protection declaration. 2. Males and females (postmenopausal or surgically sterile females) aged ≥ 18 years and ≤ 90 years 3. 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. 4. Patients with HCM or CA (according to current guidelines) 5. Kidney functions eGFR (Estimated Glomerular Filtration Rate) \> 30 mL/min/1.73 m2 6. Healthy volunteers (cohort specific criteria): adults with no known pre-existing medical conditions. Exclusion Criteria: 1. Tachycardia (heart rate \> 100, R-R interval \< 600 ms) 2. NYHA IV 3. Previous coronary artery disease requiring intervention, including history of myocardial infarction including septal reduction therapies 4. Severely reduced renal function, defined as eGFR \< 30 mL/min/1.73 m2 5. Severely reduced liver function (Child-Pugh class C), especially severe obstructive hepatobiliary disease 6. Phaeochromocytoma 7. Advanced cancer (with short/medium term prognosis) 8. History of chest radiation therapy 9. Diabetic patients 10. Severe valvular disease 11. Previous heart surgery 12. Left ventricular assist device (LVAD) 13. Severe pulmonary disease 14. Hypersensitivity to any medicinal products containing gadolinium 15. Hypersensitivity to the active substance of the IMP or to any of the excipients 16. Contraindications to MRI, including implanted cardiac devices/pacemakers 17. Participants not able to follow instructions necessary to conduct the MRI 18. Women of childbearing potential 19. Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days 20. Previous participation in this clinical trial 21. History of ongoing drug abuse or alcoholism 22. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope, and possible impact of the trial 23. Investigator site staff and sponsor directly involved in the conduct of the study and their family members.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Oslo University Hospital, Department of Cardiology, Rikshospitalet Sognsvannsveien 20
Oslo, Oslo, 0372, Norway
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Other studies related to the condition(s) this trial covers.
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