RecruitingOBSERVATIONAL

The Force Frequency Relationship in Heart Failure and Diabetes Mellitus: a Metabolic Aetiology?

This research aims to understand why the heart's pumping power sometimes doesn't get stronger as the heart beats faster, particularly in people with heart failure or diabetes. We believe there might be a link to how the body uses energy (metabolism). During pacemaker or defibrillator surgery, we'll take tiny samples of fat, muscle, and blood to see what's happening at a very detailed level. Afterwards, we'll monitor your heart's function with scans. The goal is to learn more about how the heart and other muscles communicate, which could lead to new and better treatments for these conditions in the future.

At a glance

Status

Recruiting

Sponsor

University of Leeds

Enrolment target

160

Start

01 Sep 2024

Estimated completion

30 Aug 2034

Heart Failure Diabetes (DM)

What is this study about?

Imagine your heart is a pump. When you exercise, your heart usually beats faster and pumps harder to keep up with your body's needs. For some people with heart failure, this doesn't happen as effectively. This study is trying to understand why this might be the case, especially if you also have diabetes. We think that problems with how your body turns food into energy (called metabolism) could be a big part of it.

We'll be looking closely at very small samples of tissue and blood taken during your pacemaker or defibrillator operation. This includes tiny pieces of fat and muscle from the operation site, and some blood from near your heart and elsewhere. We'll also take measurements at different heart rates to see how everything changes. After your surgery, during your regular check-ups, we'll continue to monitor your heart’s pumping ability for six months using special scans that don't involve surgery.

The main aim is to discover if abnormal metabolism is causing the heart to not pump as strongly as it should when it works harder. We also want to see if diabetes plays a role in this. By understanding the connections between the heart, other muscles, and how your body uses energy, we hope to open doors to completely new treatments and ways to help people with heart failure and diabetes live healthier lives.

Key takeaways

Study focused on heart failure and diabetes.
Aims to understand how the heart's pumping changes with heart rate.
Investigating links to the body's energy use (metabolism).
Samples taken during planned pacemaker/defibrillator surgery.
Involves heart scans during routine follow-up for 6 months.
Could help develop new treatments for these conditions.

Who may be eligible?

This study is looking for adults aged 18 or over who are already scheduled to have a pacemaker implanted (fitted with a heart device). You need to be able to understand the study and agree to take part in writing.

There are certain reasons why you might not be able to join. For instance, if you have very low blood counts (anaemia), a serious infection, acute heart problems like a recent heart attack, or serious kidney or liver failure. Pregnant or breastfeeding women cannot take part, nor can people who are already taking part in another drug trial or have allergies to certain medical dye.

Generally, you must be in a stable condition and not have any acute, serious illnesses that would make it unsafe or unsuitable for you to participate.

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?
Are you scheduled for a pacemaker or defibrillator implantation?
Do you feel well enough to participate, without any acute infections or serious conditions?
Are you not pregnant or breastfeeding?
Are you not currently involved in another medical drug trial?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the main part of the study happens during and around your pacemaker or defibrillator implantation. During the operation, the doctors will take tiny samples of fat and muscle from the area where the device is being fitted. They will also take a few small blood samples from different parts of your body, including near your heart, while they adjust your heart rate using the pacemaker.

After your operation, you'll have specific heart scans (ultrasounds) during your routine clinic visits over the next six months to check your heart's function. For most people, your direct involvement will end after these six months. However, the researchers will continue to look at your routine health records each year for up to five more years, and potentially longer, to see how your health progresses over time. No new treatments will be given as part of this study.

Potential risks and benefits

Taking part in this study means you'll contribute to important research that could lead to better treatments for heart failure and diabetes. There aren't any direct personal benefits for you during the study, but the information gained will help future patients. The risks are generally very low, as the samples are taken during your planned surgery, meaning no extra cuts or invasive procedures. The blood draws are similar to routine tests. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

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

Leeds Teaching Hospitals NHS Trust
Verified postcode
Leeds, United Kingdom· Recruiting

Common questions

What is 'heart failure'?

Heart failure means your heart isn't pumping blood around your body as effectively as it should. It doesn't mean your heart has stopped working.

What is 'diabetes'?

Diabetes is a condition where your blood sugar level is too high, either because your body doesn't make enough insulin or can't use the insulin it makes effectively.

Will I have to take any new medicines?

No, this study does not involve taking any new medications or changing your current treatment plan.

How long will I be actively involved in the study?

Your active involvement with direct tests and visits will last for about six months after your pacemaker operation.

Will my doctors know if I don't want to join?

Yes, but your decision will not affect your medical care or relationship with your doctors in any way.

How to find out more

Klaus K Witte, MD

k.k.witte@leeds.ac.uk 00441133926642 Official trial record

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