NCT06731738CompletedPhase 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.
A Phase 2 Proof-of-Concept Clinical Trial to Quantify Myocardial Manganese Uptake Rate by Cardiovascular Magnetic Resonance Imaging Following Mangafodipir Trisodium Administration in Healthy Volunteers and Heart Failure Patients With Preserved Ejection Fraction Caused by Hypertrophic Cardiomyopathy or Cardiac Amyloidosis.
Source: ClinicalTrials.gov · Last updated 8 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 25 Nov 2024
- Start date
- 22 Nov 2024
- Primary completion date
- 29 Nov 2025
- Lead sponsor
- IC TARGETS AS
- NCT number
- NCT06731738
- EU CT number
- 2023-508118-40-01
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 44
- From 22 Nov 2024 to the primary completion date, 29 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous coronary artery disease requiring intervention, including history of myocardial infarction including septal reduction therapies
- Previous heart surgery
- Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days
- Previous participation in this clinical trial
Other illness
- Tachycardia (heart rate \> 100, R-R interval \< 600 ms)
- Severely reduced liver function (Child-Pugh class C), especially severe obstructive hepatobiliary disease
- Advanced cancer (with short/medium term prognosis)
- History of chest radiation therapy
- Severe valvular disease
- Severe pulmonary disease
- Hypersensitivity to any medicinal products containing gadolinium
- Hypersensitivity to the active substance of the IMP or to any of the excipients
- Contraindications to MRI, including implanted cardiac devices/pacemakers
- History of ongoing drug abuse or alcoholism
Lab values
- Severely reduced renal function, defined as eGFR \< 30 mL/min/1.73 m2
Other
- NYHA IV
- Phaeochromocytoma
- Diabetic patients
- Left ventricular assist device (LVAD)
- Participants not able to follow instructions necessary to conduct the MRI
- Women of childbearing potential
- Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope, and possible impact of the trial
- Investigator site staff and sponsor directly involved in the conduct of the study and their family members.
Who the study is looking for
- 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)
- Kidney functions eGFR (Estimated Glomerular Filtration Rate) \> 30 mL/min/1.73 m2
- Healthy volunteers (cohort specific criteria): adults with no known pre-existing medical conditions.
Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.