RecruitingOBSERVATIONAL

The Sarcopenia Study

This study aims to understand how common muscle weakness, known as sarcopenia, is among people living with heart failure. Researchers are particularly interested in seeing if there are differences in sarcopenia depending on the type of heart failure someone has. They will compare people with heart failure to healthy volunteers and adults with type 2 diabetes. By using advanced scans and physical tests, the study hopes to gather important information about muscle strength, size, and how muscles use energy in people with heart failure. This could help us better understand and manage heart failure in the future.

At a glance

Status

Recruiting

Sponsor

University of Leicester

Enrolment target

Start

06 Dec 2023

Estimated completion

01 Sep 2026

Heart Failure Sarcopenia Heart Failure With Reduced Ejection Fraction Heart Failure With Preserved Ejection Fraction Type 2 Diabetes Frailty

What is this study about?

Heart failure is a complex condition where the heart struggles to pump blood effectively around your body. Because it's so complex, it can affect many different body systems and can significantly impact your daily life. Sometimes, people with heart failure also experience muscle weakness, which doctors often call sarcopenia. This can make you feel tired, weak, and sometimes affect your balance or ability to stand.

This study wants to find out more about this muscle weakness in people with heart failure. The main goal is to see how common sarcopenia is and if it affects different types of heart failure patients in different ways. Researchers will compare people with heart failure to healthy volunteers and also to adults who have type 2 diabetes but no heart failure symptoms, to get a clear picture.

By understanding more about muscle weakness in heart failure, we hope this research can eventually lead to better ways to support people's muscle health, improve their quality of life, and potentially develop new treatments for living with heart failure.

Key takeaways

This study explores muscle weakness (sarcopenia) in heart failure patients.
It compares heart failure patients with healthy volunteers and people with type 2 diabetes.
Assessments include body scans, muscle strength tests, and physical performance tasks.
The goal is to understand muscle health in heart failure for future improvements in care.
If you have heart failure, you must be 65+ and stable for 3 months to be eligible.
Participation is voluntary and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to be aged 65 or older if you have heart failure, or between 18 and 75 if you have type 2 diabetes, and 18 or older if you are a healthy volunteer. For heart failure patients, your condition needs to have been stable for at least three months, meaning you haven't been admitted to hospital for it recently.

There are also some reasons why you might not be able to take part. For instance, if you have certain other muscle or nerve conditions, use certain medications like steroids regularly, or have uncontrolled thyroid problems, this study might not be suitable for you. If you can't walk or do a walking test, or if you have certain heart conditions or severe kidney disease, you also wouldn't be able to join. Your doctor can help you understand all the specifics.

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.

Do I have a diagnosis of heart failure, or type 2 diabetes, or am I a healthy adult?
If I have heart failure, has my condition been stable for at least 3 months?
Do I meet the age requirements (e.g., 65+ for heart failure, 18-75 for type 2 diabetes)?
Am I able to walk and perform simple physical tests?
Do I have any conditions that would prevent an MRI scan or other tests?
Do I have any other major heart problems, severe kidney disease, or certain muscle/nerve disorders?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo several assessments. These include body scans like MRI and BIA to look at your muscle size and quality. You'd also do various physical tests to measure your muscle strength, such as handgrip tests and exercises for your leg muscles. There will also be simple tests like walking, balancing, and standing tests to see how your whole body performs.

Additionally, some assessments will look at how your muscles use energy, possibly involving a special type of scan (spectroscopy) before and after exercise, particularly for your calf muscles. For some participants, a small muscle sample (biopsy) will be taken. Researchers will also compare results between different groups. The total duration of participation and number of visits aren't specified but typically involves a few comprehensive assessment sessions.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as gaining a detailed understanding of your own muscle health through the various assessments. While there are no direct medical benefits for your specific condition, your participation will help doctors and researchers better understand heart failure and muscle weakness, potentially leading to improved care for others in the future. As with any medical study, there are some potential risks associated with the tests, such as minor discomfort from blood tests or muscle biopsies, or claustrophobia during MRI scans. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

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

University Hospitals of Leicester NHS Trust
Verified postcode
Leicester, United Kingdom· Recruiting

Common questions

What is sarcopenia?

Sarcopenia is a medical term for muscle weakness, meaning you have reduced muscle strength, size, and sometimes problems with how your muscles work.

Why is this study looking at heart failure patients?

The study aims to understand how common muscle weakness is in people with heart failure, as it's a condition that can affect many parts of the body, including muscles.

What kind of tests will I have?

You'll have body scans (like MRI), strength tests (like handgrip), and simple physical activity tests (like walking and balancing). Some may also have a small muscle sample taken.

Do I have to take new medication?

No, this is an observational study, which means you won't be given any new medications as part of your participation.

Can I leave the study at any time?

Yes, you are free to withdraw from the study at any point without it affecting your medical care.

How to find out more

Sally Utton

su47@leicester.ac.uk 44 (0)116 204 4786 Official trial record

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