Heart Failure With Preserved Ejection Fraction (HFPEF)Phase 2NCT06731738
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 study testing Gadoteric acid and Mangafodipir trisodium injection in people with Heart Failure With Preserved Ejection Fraction (HFPEF), run by IC TARGETS AS at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction (HFPEF)
- What is being tested?
- Gadoteric acid and Mangafodipir trisodium injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteNorway
- Study dates
- 22 Nov 2024to 29 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Tachycardia (heart rate > 100, R-R interval < 600 ms)
- NYHA IV
- Previous coronary artery disease requiring intervention, including history of myocardial infarction including septal reduction therapies
- Severely reduced renal function, defined as eGFR < 30 mL/min/1.73 m2
- Severely reduced liver function (Child-Pugh class C), especially severe obstructive hepatobiliary disease
- Phaeochromocytoma
Show all 23Show fewer
- Advanced cancer (with short/medium term prognosis)
- History of chest radiation therapy
- Diabetic patients
- Severe valvular disease
- Previous heart surgery
- Left ventricular assist device (LVAD)
- 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
- Participants not able to follow instructions necessary to conduct the MRI
- Women of childbearing potential
- Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days
- Previous participation in this clinical trial
- History of ongoing drug abuse or alcoholism
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital, Department of Cardiology, Rikshospitalet Sognsvannsveien 20
Oslo, Oslo, 0372
About this study
Official title: 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.
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.
Read the detailed description
The trial is an open-label, single centre, Phase 2A, Proof-of-Concept (PoC) trial in adult male and female patients without randomisation.
Overall, up to 42 participants will be enrolled in this trial:
- A run-in phase will include up to 6 participants (healthy volunteers and HFpEF patients regardless of aetiology (HCM, CA).
- The main phase of the trial will include 12 HFpEF with HCM, 12 HFpEF with CA and 12 healthy volunteers.
During a run-in phase up to 6 participants will be enrolled to standardise the trial procedures, especially mangafodipir-enhanced imaging.
The number and sequence of trial visits will be the same for participants of the run-in and the main phase.
All enrolled participants will undergo gadolinium-enhanced imaging at Visit 2. A gadolinium-based contrast agent (authorised AMP) will be injected i.v. and T1 mapping and Extracellular Volume (ECV) measurement will be done for approximately 60 minutes.
Mangafodipir-enhanced mapping will be done at Visit 3. After baseline T2 mapping, mangafodipir trisodium injection (IMP) will be administered i.v. and T1 mapping, Saturation Recovery T1 weighted imaging for measurement of the uptake rate, and T2 mapping, will be done for approximately 90 minutes.
Clinical safety data will be collected throughout the trial; the participants will be followed up by a phone call 24+6 hours after Visit 3 for evaluation of late-appearing AEs.
The analyses of the images will be done by an investigator of the study team, blinded to the clinical data.
- Being tested
- Gadoteric acid, Mangafodipir trisodium injection
- Keywords
- Mangafodipir, HFpEF, CMR, Heart Failure, Heart Disease, Manganese-enhanced magnetic resonance imaging (MEMRI)
- Medical subject headings
- Heart Failure, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadoteric acidDrug
A gadolinium-based contrast agent (authorised auxiliary medicinal product (AMP)) will be injected i.v. at a dose of 0.2 mmol Gd/kg bw and T1 mapping and ECV measurement will be done.
Mangafodipir trisodium injectionDrug
Mangafodipir trisodium injection (IMP) will be administered i.v. at a dose of 5 µmol/kg bw and T1 mapping, Saturation Recovery T1 weighted imaging for measurement of the uptake rate, and T2 mapping, will be done.
| Study group | Role | What they receive |
|---|---|---|
| HFpEF with HCM | Experimental | Heart failure patients with preserved ejection fraction caused by hypertrophic cardiomyopathy.
Participants will have 2 cardiac MRIs (gadolinium- and manganese-enhanced) at Visit 2 and Vist 3, respectively. Receives: Drug: Gadoteric acid; Drug: Mangafodipir trisodium injection |
| HFpEF with CA | Experimental | Heart failure patients with preserved ejection fraction caused by cardiac amyloidosis.
Participants will have 2 cardiac MRIs (gadolinium- and manganese-enhanced) at Visit 2 and Vist 3, respectively. Receives: Drug: Gadoteric acid; Drug: Mangafodipir trisodium injection |
| Healthy Volunteers | Experimental | Participants will have 2 cardiac MRIs (gadolinium- and manganese-enhanced) at Visit 2 and Vist 3, respectively. Receives: Drug: Gadoteric acid; Drug: Mangafodipir trisodium injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantify the manganese uptake rate after administration of mangafodipir trisodium in all segments of the left ventricular wall.
Determination of the manganese uptake rate.
Measured: 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.
Secondary outcomes (5)
Efficacy: Comparison of manganese uptake rate constant in healthy volunteers, HFpEF with HCM or CA.
Difference in the uptake rate constant between healthy volunteers, HFpEF with HCM or CA.
Measured: 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.
To assess the safety of mangafodipir trisodium injection based on AEs.
Frequency and severity of adverse events (AE).
Measured: From AMP administration at Visit 2 to the end of the Follow-up period (1 day after Vist 3).
To assess the safety of mangafodipir trisodium injection based on injection site AEs.
Frequency of injection site AEs.
Measured: From AMP administration at Visit 2 to the end of the Follow-up period (1 day after Vist 3).
To assess the safety of mangafodipir trisodium injection based on vital signs.
Significant changes in vital signs.
Measured: From AMP administration at Visit 2 to the end of the Follow-up period (1 day after Vist 3).
To assess the safety of mangafodipir trisodium injection based on ECG.
Significant changes in ECG.
Measured: From AMP administration at Visit 2 to the end of the Follow-up period (1 day after Vist 3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start22 Nov 2024
- Primary completion29 Nov 2025
- Study completion29 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection Fraction (HFPEF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- IC TARGETS AS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731738
- Sponsor's protocol ID
- MNC001
- Other IDs
- 2023-508118-40-01, 2023
- Status last verified
- Jan 2026
- First submitted
- 25 Nov 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06731738
- Acronym / sponsor ID
- MNC001
- Keywords
- Mangafodipir, HFpEF, CMR, Heart Failure, Heart Disease, Manganese-enhanced magnetic resonance imaging (MEMRI)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- IC TARGETS ASUniversity, hospital or other
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 29 Nov 2025 (actual)
- Study completion
- 29 Nov 2025 (actual)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial is an open-label, single centre, Phase 2A, Proof-of-Concept (PoC) trial in adult male and female patients without randomisation.
Overall, up to 42 participants will be enrolled in this trial:
- A run-in phase will include up to 6 participants (healthy volunteers and HFpEF patients regardless of aetiology (HCM, CA).
- The main phase of the trial will include 12 HFpEF with HCM, 12 HFpEF with CA and 12 healthy volunteers.
During a run-in phase up to 6 participants will be enrolled to standardise the trial procedures, especially mangafodipir-enhanced imaging.
The number and sequence of trial visits will be the same for participants of the run-in and the main phase.
All enrolled participants will undergo gadolinium-enhanced imaging at Visit 2. A gadolinium-based contrast agent (authorised AMP) will be injected i.v. and T1 mapping and Extracellular Volume (ECV) measurement will be done for approximately 60 minutes.
Mangafodipir-enhanced mapping will be done at Visit 3. After baseline T2 mapping, mangafodipir trisodium injection (IMP) will be administered i.v. and T1 mapping, Saturation Recovery T1 weighted imaging for measurement of the uptake rate, and T2 mapping, will be done for approximately 90 minutes.
Clinical safety data will be collected throughout the trial; the participants will be followed up by a phone call 24+6 hours after Visit 3 for evaluation of late-appearing AEs.
The analyses of the images will be done by an investigator of the study team, blinded to the clinical data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HFpEF with HCM | Experimental | Drug: Gadoteric acid, Drug: Mangafodipir trisodium injectionHeart failure patients with preserved ejection fraction caused by hypertrophic cardiomyopathy. Participants will have 2 cardiac MRIs (gadolinium- and manganese-enhanced) at Visit 2 and Vist 3, respectively. |
| HFpEF with CA | Experimental | Drug: Gadoteric acid, Drug: Mangafodipir trisodium injectionHeart failure patients with preserved ejection fraction caused by cardiac amyloidosis. Participants will have 2 cardiac MRIs (gadolinium- and manganese-enhanced) at Visit 2 and Vist 3, respectively. |
| Healthy Volunteers | Experimental | Drug: Gadoteric acid, Drug: Mangafodipir trisodium injectionParticipants will have 2 cardiac MRIs (gadolinium- and manganese-enhanced) at Visit 2 and Vist 3, respectively. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (23 listed)
- Tachycardia (heart rate > 100, R-R interval < 600 ms)
- NYHA IV
- Previous coronary artery disease requiring intervention, including history of myocardial infarction including septal reduction therapies
- Severely reduced renal function, defined as eGFR < 30 mL/min/1.73 m2
- Severely reduced liver function (Child-Pugh class C), especially severe obstructive hepatobiliary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gadoteric acidA gadolinium-based contrast agent (authorised auxiliary medicinal product (AMP)) will be injected i.v. at a dose of 0.2 mmol Gd/kg bw and T1 mapping and ECV measurement will be done. | Drug | HFpEF with CA, HFpEF with HCM, Healthy Volunteers |
| Mangafodipir trisodium injectionMangafodipir trisodium injection (IMP) will be administered i.v. at a dose of 5 µmol/kg bw and T1 mapping, Saturation Recovery T1 weighted imaging for measurement of the uptake rate, and T2 mapping, will be done. | Drug | HFpEF with CA, HFpEF with HCM, Healthy Volunteers |
Primary outcome
To quantify the manganese uptake rate after administration of mangafodipir trisodium in all segments of the left ventricular wall.
Time frame: 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.
Determination of the manganese uptake rate.
5 secondary outcomes
Efficacy: Comparison of manganese uptake rate constant in healthy volunteers, HFpEF with HCM or CA.
Time frame: 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.
To assess the safety of mangafodipir trisodium injection based on AEs.
Time frame: From AMP administration at Visit 2 to the end of the Follow-up period (1 day after Vist 3).
To assess the safety of mangafodipir trisodium injection based on injection site AEs.
Time frame: From AMP administration at Visit 2 to the end of the Follow-up period (1 day after Vist 3).
To assess the safety of mangafodipir trisodium injection based on vital signs.
Time frame: From AMP administration at Visit 2 to the end of the Follow-up period (1 day after Vist 3).
To assess the safety of mangafodipir trisodium injection based on ECG.
Time frame: From AMP administration at Visit 2 to the end of the Follow-up period (1 day after Vist 3).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gadoteric acid and Mangafodipir trisodium injection in people with Heart Failure With Preserved Ejection Fraction (HFPEF), run by IC TARGETS AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To quantify the manganese uptake rate after administration of mangafodipir trisodium in all segments of the left ventricular wall. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.