All studies
Not yet recruitingPHASE2INTERVENTIONAL

Digoxin and Senolysis in Heart Failure and Diabetes Mellitus

This research is investigating a new way to help people who have both heart failure (where the heart can't pump blood effectively) and type 2 diabetes. Past small studies have shown that fat tissue in these patients might not work properly because of certain old or 'senescent' cells. We've also seen that a long-used heart medicine called Digoxin might be able to remove these tired cells and help the fat tissue function better. This study will give Digoxin to patients and then look at their fat tissue to see if it reduces the number of these senescent cells. The aim is to understand if Digoxin can offer a new benefit beyond its current uses for these health conditions.

At a glance

Status
Not yet recruiting
Phase
PHASE2
Sponsor
University of Leeds
Enrolment target
100
Start
01 Sep 2025
Estimated completion
28 Aug 2029

What is this study about?

This research is looking into a problem that affects many people: having both heart failure and type 2 diabetes. Heart failure means your heart isn't pumping blood as well as it should, and type 2 diabetes is a condition where your body struggles to use sugar for energy. When these two conditions happen together, they can make each other worse.

Our previous small studies have found something interesting. In people with both heart failure and type 2 diabetes, the fat under their skin (called subcutaneous adipose tissue) might not be working correctly. We discovered that certain cells in this fat tissue become 'old' or 'tired' – doctors call these 'senescent cells'. These tired cells seem to cause problems for the healthy fat cells around them, making it harder for them to do their job, like taking up sugar from the blood.

We are now exploring a medicine called Digoxin, which has been used for a long time to treat heart failure. Our early findings suggest that Digoxin might be able to specifically get rid of these tired, senescent cells in the fat tissue. By clearing out these problematic cells, we hope Digoxin could help the fat tissue work better in people with both heart failure and type 2 diabetes. This study aims to confirm whether Digoxin can indeed reduce these tired cells in the fat tissue of patients.

Key takeaways

  • This study investigates if Digoxin helps people with heart failure and type 2 diabetes.
  • It aims to see if Digoxin clears 'tired' cells in fat tissue.
  • The goal is to understand how these conditions interact and find new treatments.
  • Digoxin is a well-known heart medication being explored for an additional benefit.
  • Participation involves specific health criteria for both heart and diabetes conditions.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have both heart failure (specifically with a reduced pumping ability, known as HFrEF) and type 2 diabetes. For your diabetes, you should be taking medication, and your recent blood tests (fasting plasma glucose or HbA1c) need to show certain levels.

It's important that you are already receiving the best possible regular care for your conditions. You also need to be willing and able to understand the study and give your written permission to take part.

However, some things might prevent you from joining. These include severe memory problems, other serious health issues that would make it hard to follow the study's plan, very high potassium levels in your blood, or very poor kidney function. Also, if you've been in another research study within the last six months, you wouldn't be able to participate in this one.

Quick self-check
  • Are you 18 years old or older?
  • Do you have heart failure with reduced pumping ability (HFrEF)?
  • Do you have type 2 diabetes and are taking medication for it, with specific blood sugar levels?
  • Are you currently receiving the best regular medical care for your conditions?
  • Do you have any serious memory problems or other major illnesses that might make it hard to take part?
  • Have you participated in another study in the past 6 months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

This section has not been provided in the brief. Please refer to the study coordinators for details on participation requirements, including visits, assessments, medication, follow-up, and total duration.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is helping researchers understand if Digoxin can improve fat tissue function in people with heart failure and type 2 diabetes, which could contribute to better treatments in the future. However, there's no guarantee that you personally will experience a direct benefit. Potential risks are generally linked to taking a medication like Digoxin, which can have side effects, and undergoing study procedures, though specific risks would be fully explained before you agree to participate. You have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

  • Leeds Teaching Hospitals NHS Trust
    Leeds, United Kingdom

Common questions

What is 'heart failure with reduced ejection fraction' (HFrEF)?

This is a type of heart failure where your heart's main pumping chamber (left ventricle) isn't squeezing as strongly as it should, leading to less blood being pumped out to your body.

What are 'senescent cells'?

These are often called 'old' or 'tired' cells. They stop multiplying and can sometimes cause problems for the healthy cells around them rather than helping the body.

How does Digoxin work?

Digoxin is a medicine that helps your heart beat more strongly and regularly. In this study, we're exploring if it might also have another effect on certain cells in body fat.

Will I know if I'm getting Digoxin or not?

This type of study often involves 'blinding,' meaning neither you nor the study team will know if you're taking the active medicine or a dummy pill (placebo) until the study ends. This helps ensure fair results.

What body fat will be studied?

The study focuses on 'subcutaneous adipose tissue,' which is the fat just under your skin, often found in places like your tummy or thighs.

How to find out more

Klaus Witte

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

Interested in taking part?

Register your interest

Share your details and the research team for "Digoxin and Senolysis in Heart Failure and Diabetes Mellitus…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.