Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

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 research study is trying to find a new way to understand certain heart conditions. It's looking at how quickly manganese, a natural substance, is taken up by the heart. Participants will have a special heart scan called a cardiovascular magnetic resonance imaging (CMR) after being given a small amount of a medication containing manganese. Researchers will compare how fast manganese goes into the heart in healthy volunteers versus people with heart failure caused by either hypertrophic cardiomyopathy or cardiac amyloidosis. The main goal is to see if this scan can accurately measure manganese uptake. They will also be checking for any side effects and looking for differences in manganese uptake between the groups. This study is in an early stage (Phase 2), meaning it's still exploring if this new method works.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

IC Targets AS

Enrolment target

Start

20 Sep 2024

Heart Failure

What is this study about?

This study aims to discover a brand new way to look at how the heart works, especially in people with certain types of heart failure. You might know that your heart is a muscle that pumps blood around your body. Sometimes, this muscle can become stiff or thickened, making it harder for the heart to do its job properly. This can be caused by conditions like hypertrophic cardiomyopathy or cardiac amyloidosis, which are specific reasons someone might have heart failure.

Researchers are using a special type of scan called a cardiovascular magnetic resonance imaging (CMR) scan. This is similar to an MRI scan and gives very detailed pictures of your heart. Before the scan, participants will be given a small amount of a special substance called mangafodipir trisodium, which contains manganese. Manganese is a natural element that your body uses, and in this study, it acts like a marker so researchers can see how much of it goes into the heart muscle.

The main point of the study is to measure how quickly your heart takes up this manganese. By comparing healthy volunteers with people who have these specific heart conditions, scientists hope to learn if this new scanning method can tell the difference between healthy and affected hearts. This could potentially lead to better ways to diagnose or monitor these heart conditions in the future. It's an early-stage study, so they are still exploring if this method is effective and safe.

Key takeaways

This study explores a new way to scan the heart.
It uses a special substance containing manganese.
Compares healthy people with specific heart failure patients.
Aims to understand how heart conditions affect manganese uptake.
Phase 2, so it's a relatively early-stage research.
Not a treatment, but could lead to better diagnostics.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

The study is specifically looking for two groups of people: healthy volunteers who don't have heart problems, and patients who have been diagnosed with a specific type of heart failure. This heart failure must be caused by either hypertrophic cardiomyopathy (where the heart muscle is thickened) or cardiac amyloidosis (where abnormal proteins build up in the heart).

There will be other specific medical criteria that you would need to meet to ensure your participation is safe and effective for the study. For example, your doctors will check your overall health and look at your medical history to make sure you are a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of hypertrophic cardiomyopathy or cardiac amyloidosis, or are you generally healthy?
Are you able to undergo an MRI scan?
Are you able to attend study visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if you are suitable. This would involve medical checks, blood tests, and discussions about your health. If you qualify, you would then have a study visit where you would receive a small amount of the study medication, mangafodipir trisodium, through a drip into your arm. Afterwards, you would have a special heart scan (CMR scan) to see how the manganese is taken up by your heart. You might have other assessments like ECGs (heart tracings) and vital sign checks to monitor your safety. The total duration of your participation would likely involve a few visits and tests over a short period, with follow-up to ensure you are well. The exact number of visits and tests will be explained in full by the study team.

Potential risks and benefits

Participating in research always comes with potential benefits and potential risks. A potential benefit of this study is helping researchers learn more about heart conditions, which could lead to better diagnostic methods in the future. You would also receive detailed heart health checks as part of your participation. However, there are potential risks, such as side effects from the study medication, including reactions at the injection site. There's also the discomfort and very small risks associated with having an MRI scan. All procedures will be explained in detail, and your safety will be closely monitored throughout the study. Remember, if you decide to join, you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Norway

Common questions

What is manganese and is it safe?

Manganese is a natural substance found in your body in small amounts. The study is using a specific form of it, and its safety will be carefully monitored by the research team.

What is a CMR scan?

A CMR scan is a special type of MRI scan that takes very detailed pictures of your heart, helping doctors see its structure and how it's working.

Will I feel anything when the manganese is given?

The medication will be given through a drip, and you might feel a small prick when the needle is inserted. The research team will explain any potential sensations you might experience.

Does this study treat my heart condition?

No, this is a research study focused on understanding heart conditions better. It is not designed to treat your heart condition.

How long will my involvement in the study last?

Your involvement typically includes a few visits for screening, the study procedures, and follow-up. The exact duration will be discussed by the study team before you decide to take part.