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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508118-40-01

Acronym

MNC001

Enrollment

Registered

2024-09-20

Start date

2024-11-22

Completion date

2025-11-29

Last updated

2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

Primary endpoint: Determination of the manganese uptake rate.

Detailed description

Efficacy: Difference in the uptake rate constant between healthy volunteers, HFpEF with HCM or CA., Safety: Frequency and severity of adverse events, injection site AEs, significant changes in vital signs, significant changes in ECG

Interventions

DRUGDotarem 279

DRUG3 mg/ml injeksjonsvæske

DRUGoppløsning

DRUGANHYDROUS MANGAFODIPIR TRISODIUM

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary endpoint: Determination of the manganese uptake rate.	—

Secondary

Measure	Time frame
Efficacy: Difference in the uptake rate constant between healthy volunteers, HFpEF with HCM or CA., Safety: Frequency and severity of adverse events, injection site AEs, significant changes in vital signs, significant changes in ECG	—

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026