RecruitingOBSERVATIONAL

Manganese-enhanced Magnetic Resonance Imaging (MEMRI) in Heart Failure With Preserved Ejection Fraction

Heart failure with preserved ejection fraction (HFpEF) is a common condition where the heart struggles to fill with blood properly, leading to tiredness, breathlessness, and swelling. It often means hospital trips and can shorten lives. We don't fully understand why it happens, and there are few effective treatments. Type 2 Diabetes makes HFpEF worse. This study uses advanced MRI scans with a special dye to look closely at how the heart muscles of people with HFpEF — with and without Type 2 Diabetes — handle calcium and use energy. These are crucial for a healthy heartbeat. By comparing these groups with healthy volunteers, researchers hope to discover why the combination of diabetes and HFpEF is particularly harmful and find new ways to help patients.

At a glance

Status

Recruiting

Sponsor

University of Leicester

Enrolment target

Start

10 Oct 2024

Estimated completion

01 Feb 2036

Heart Failure With Preserved Ejection Fraction Type 2 Diabetes

What is this study about?

Imagine your heart as a pump that sends blood around your body. In a condition called heart failure with preserved ejection fraction (we'll call it HFpEF for short), the heart can't relax and fill with blood as well as it should. This doesn't mean your heart isn't working at all, but it struggles to do its job effectively. This can make you feel very tired, short of breath, and cause your ankles to swell. It can also lead to repeated hospital stays and can sadly shorten people's lives.

One of the puzzling things about HFpEF is that we don't know much about why it develops or how to treat it. We do know that having Type 2 Diabetes often makes HFpEF much worse, leading to more hospital visits and a greater risk of early death. We think this might be because diabetes affects how the heart muscles handle an important mineral called calcium, and how efficiently the heart uses energy. Both calcium and energy are vital for your heart to pump and fill properly.

This study uses new and improved MRI scans (a special type of body scan) along with a unique dye called manganese. This allows doctors to get incredibly detailed pictures of the heart. They can see its shape, how well it's working, and importantly, how it's handling calcium and energy, all in one scan. We are looking for 40 volunteers with HFpEF – half of whom also have Type 2 Diabetes, and half who don't – as well as up to 20 healthy volunteers. By comparing these groups, we hope to learn more about the differences in their hearts and understand why diabetes makes HFpEF more severe. This information could lead to better treatments in the future.

Key takeaways

Study focuses on heart failure (HFpEF) and Type 2 Diabetes.
Uses advanced MRI scans to look at heart's calcium and energy.
Aims to understand why diabetes makes HFpEF worse.
No new medications are given in this study.
Looks for volunteers with HFpEF and healthy people.

Who may be eligible?

To join this study, you must be able to understand what is involved and agree to take part. You might be suitable if you have been diagnosed with HFpEF or have symptoms like breathlessness, swollen ankles, or tiredness, and your doctor believes you meet specific diagnostic criteria for HFpEF.

There are certain reasons why you wouldn't be able to join. For instance, if you have Type 1 Diabetes, are pregnant or breastfeeding, or have certain other serious heart conditions like advanced valve disease. You also can't take part if you have certain existing medical conditions (like severe kidney or liver problems) or if you have any metal implants in your body (like a pacemaker) that would make an MRI scan unsafe. If you've had a recent heart attack (within the last 3 months) or are currently taking part in another drug trial, you also wouldn't be able to join.

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?
Have you been diagnosed with HFpEF or have related symptoms?
Do you have any metal implants that prevent MRI scans (like a pacemaker)?
Are you currently pregnant or breastfeeding?
Do you have certain severe kidney or liver problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will have several assessments. These include filling out a questionnaire about how heart failure affects your daily life (Minnesota Living with Heart Failure Questionnaire), undergoing a detailed heart ultrasound (Echocardiogram), and completing a six-minute walk test to see how far you can walk in that time. You will also have blood tests. The main part of the study involves special heart MRI scans. This includes a manganese-enhanced MRI and another scan called 31-P magnetic resonance spectroscopy, which look at your heart's calcium use and energy. You'll also have a standard cardiovascular magnetic resonance scan. The study team will explain everything to you in detail before you agree to take part. The exact number of visits will be explained by the study organisers, but generally, studies like this involve a few visits over a short period, with all tests done during these visits. There won't be any new medication given as part of this study.

Potential risks and benefits

Taking part could help us understand heart failure better, which might lead to improved treatments for others in the future. There might not be a direct benefit to your health from participating, but your health will be monitored. Risks include discomfort from blood tests and lying still during MRI scans, and a small risk from the manganese dye (which will be fully explained). You have the right to withdraw from the study at any time without giving a reason, and this won't affect your medical care.

Locations (1)

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

University of Leicester
Verified postcode
Leicester, United Kingdom· Recruiting

Common questions

What is HFpEF?

HFpEF is a type of heart failure where your heart struggles to fill properly with blood. This can make you feel tired, breathless, and cause swelling, even if your heart's pumping action seems normal on some tests.

Why is Type 2 Diabetes important in this study?

Type 2 Diabetes often makes HFpEF worse, but we don't know exactly why. This study aims to find out if it's because diabetes affects how the heart uses calcium or energy.

What is a manganese-enhanced MRI?

It's a special type of heart scan that uses a safe dye containing manganese to get very detailed pictures. It helps doctors see how your heart muscle is handling vital minerals like calcium and how it uses energy.

Will I get any medication as part of this study?

No, this study is about understanding heart function, not testing new medications. You will continue to take your usual prescribed medicines.

Who can join this study?

Adults aged 18 and over with HFpEF (with or without Type 2 Diabetes), or healthy volunteers, who don't have certain serious medical conditions or metal implants that prevent an MRI scan.

How to find out more

Gerry P McCann, MD

gpm12@leicester.ac.uk +44 (0)116 258 3038 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.