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Study on Manganese Uptake in Heart Failure Patients Using Mangafodipir Trisodium and Gadoteric Acid

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying heart failure, specifically a type called Heart Failure with preserved Ejection Fraction (HFpEF), which can be caused by conditions like hypertrophic cardiomyopathy or cardiac amyloidosis. The study will use a special substance called mangafodipir trisodium, which is a contrast agent used in Magnetic Resonance Imaging (MRI). This agent helps to highlight certain areas in the heart during imaging, making it easier to see how the heart is functioning.

The purpose of the study is to measure how quickly the heart takes up manganese, a component of the contrast agent, after it is administered. This will be done by using MRI to look at all parts of the left side of the heart. The study will include both healthy volunteers and patients with heart failure. Participants will receive the contrast agent through an injection, and their heart's response will be monitored using MRI scans.

Throughout the study, researchers will compare the manganese uptake rates between healthy individuals and those with heart failure. They will also monitor for any side effects or changes in health indicators like vital signs and heart rhythms. The study aims to provide valuable insights into heart function in patients with heart failure and how it differs from healthy individuals.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide a signed declaration of consent and a data protection declaration. This confirms your willingness to participate and ensures your data is handled securely.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes checking your age, which should be between 18 and 90 years, and ensuring you meet specific health criteria, such as having heart failure with preserved ejection fraction (HFpEF) or being a healthy volunteer with no known pre-existing medical conditions.
Step 3
Administration of contrast agent
You will receive an injection of mangafodipir trisodium, a contrast agent, through an intravenous route. This is a solution for injection that helps in imaging your heart using magnetic resonance imaging (MRI).
Step 4
Magnetic resonance imaging (MRI)
After the administration of the contrast agent, you will undergo an MRI scan. This scan is used to measure the manganese uptake rate in your heart, which is the primary objective of the study.
Step 5
Monitoring and follow-up
Throughout the trial, your health will be monitored closely. This includes checking for any adverse events, changes in vital signs, and any significant changes in your electrocardiogram (ECG).
The study aims to determine the difference in manganese uptake rates between healthy volunteers and patients with heart failure, as well as to ensure the safety of the procedure.

Who can join the trial?

6 criteria

Participants must provide their signed consent and data protection agreement.
Both males and females can participate. Females must be postmenopausal or surgically sterile. Participants must be aged between 18 and 90 years.
Participants with Heart Failure with preserved Ejection Fraction (HFpEF), which means the heart pumps normally but is stiff when relaxed. This includes those with New York Heart Association (NYHA) class I, II, and III symptoms, and evidence of heart structure or function issues, such as high levels of certain heart-related proteins.
Participants with Hypertrophic Cardiomyopathy (HCM) or Cardiac Amyloidosis (CA), as per current medical guidelines.
Participants must have kidney function with an Estimated Glomerular Filtration Rate (eGFR) greater than 30 mL/min/1.73 m². This is a measure of how well the kidneys are working.
Healthy volunteers are also welcome, meaning adults with no known existing medical conditions.

Who cannot join the trial?

7 criteria

Patients with a history of **allergic reactions** to mangafodipir trisodium or similar substances cannot participate. An allergic reaction is when your body has a bad response to something, like a rash or trouble breathing.
Patients who have **severe kidney problems** are excluded. This means if your kidneys, which help clean your blood, are not working well, you cannot join.
Patients with **liver disease** cannot take part. The liver is an organ that helps process what you eat and drink, and if it is not healthy, you cannot participate.
Women who are **pregnant or breastfeeding** are not allowed to join. This is to protect the baby.
Patients who have had a **heart attack** in the last 6 months are excluded. A heart attack happens when blood flow to the heart is blocked.
Patients with **uncontrolled high blood pressure** cannot participate. High blood pressure is when the force of your blood against your artery walls is too high.
Patients with any other **serious medical condition** that might interfere with the study are not allowed. This means if you have another health issue that could affect the study results, you cannot join.

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Verified
Oslo Universitetssykehus HF
Oslo, Norway

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Investigated drugs

Mangafodipir Trisodium is a medication used in this clinical trial to help doctors see how well the heart is working. It is given to patients to help measure how much manganese, a type of mineral, is taken up by the heart muscle. This is important because it can help doctors understand more about certain heart conditions, like heart failure or other heart diseases. The medication works by making the heart muscle more visible during a special type of heart scan called cardiovascular magnetic resonance imaging (MRI). This helps doctors get a clearer picture of the heart's health and function.

What is already known about the treatment

Mangafodipir Trisodium – This medication is administered through an injection and is used in clinical trials to study its effects on heart conditions. It is currently being researched for its ability to help visualize heart muscle activity in patients with heart failure, particularly those with specific conditions like hypertrophic cardiomyopathy or cardiac amyloidosis. The main purpose of this medication is to enhance imaging techniques by increasing the uptake of manganese in heart tissues, which can be measured using special imaging technology. Mangafodipir trisodium belongs to a class of drugs known as contrast agents, which are used to improve the clarity of medical imaging.

Investigated diseases

Heart Failure – Heart failure is a condition where the heart is unable to pump blood effectively to meet the body's needs. It can result from various underlying issues, such as coronary artery disease or high blood pressure. As the condition progresses, the heart's ability to pump diminishes, leading to symptoms like fatigue, shortness of breath, and fluid retention. Over time, the heart may become enlarged, and its walls may thicken or stiffen. This can lead to a reduced capacity to fill with blood or to pump it out efficiently. The progression of heart failure can vary, with periods of stability and episodes of worsening symptoms.