Using Mangafodipir to Improve MRI Imaging in Heart Failure 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.
This study is testing if a new imaging agent called mangafodipir can help doctors get better MRI pictures of the heart in patients with heart failure and preserved ejection fraction.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Ic Targets As Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Oslo) |
| Trial ID | NCT06731738 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the use of mangafodipir trisodium as an intracellular contrast agent in magnetic resonance imaging (MRI) to measure manganese uptake rates in patients with heart failure and preserved ejection fraction (HFpEF). It will involve a run-in phase with healthy volunteers and HFpEF patients, followed by a main phase where participants will undergo both gadolinium-enhanced and mangafodipir-enhanced imaging. The study seeks to provide insights into cellular function independent of fibrosis, which could enhance diagnosis and treatment monitoring for HFpEF. The trial will be conducted at a single center, with a total of up to 42 participants enrolled.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 90 with HFpEF and specific structural or functional cardiac abnormalities.
Not a fit: Patients with advanced heart failure (NYHA class IV) or significant tachycardia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses and better monitoring of therapies for heart failure patients.
How similar studies have performed: While the use of mangafodipir in this context is novel, similar imaging techniques have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Oslo
- Oslo University Hospital, Department of Cardiology, Rikshospitalet Sognsvannsveien 20 — Oslo, Norway (Recruiting)
Study contacts
- Study coordinator: Thor Edvardsen, MD, PhD
- Email: thor.edvardsen@medisin.uio.no
- Phone: +4723071176
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.