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Mangafodipir - an intracellular contrast agent for Magnetic Resonance Imaging (MRI): Measuring manganese uptake rate in heart failure patients with preserved ejection fraction (HFpEF) patients.
EU CTIS ID: 2023-508118-40-01
What this study is testing
To quantify the manganese uptake rate after administration of mangafodipir trisodium in all segments of the left ventricular wall.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 abnormalitieconsistent with the presence of 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 condition.
You likely can't join if
- Tachycardia (heart rate >100, R-R interval <600ms)
- Severe valvular disease.
- Previous heart surgery.
- Left ventricular assist device (LVAD).
- Severe pulmonary disease.
- Hypersensitivity to any medicinal products containing gadolinium.
See the full eligibility criteria
- 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 abnormalitieconsistent with the presence of 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 condition.
- Tachycardia (heart rate >100, R-R interval <600ms)
- 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.
- NYHA IV
- 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.
- Previous coronary artery disease requiring intervention, including history of myocardial infarction including septal reduction therapies.
- Severely reduced renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 30mL/min/1.73 m2.
- Severely reduced liver function (Child-Pugh class C), especially severe obstructive hepatobiliary disease.
- Phaeochromocytoma
- Advanced cancer (with short/medium term prognosis).
- History of chest radiation therapy.
- Diabetic patients
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.