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AuthorisedTherapeutic use (Phase IV)Interventional

The role of meldonium and individualized physical activities in the treatment of patients with heart failure

This UK clinical trial is exploring a new way to help people who have a specific type of heart failure called 'heart failure with preserved ejection fraction'. This means your heart muscle can pump blood out to your body, but it has trouble relaxing properly to fill up with blood. The study is investigating a medication called Meldonium alongside an exercise programme tailored just for you. The main goal is to see if this combination therapy can improve how well your body uses oxygen during physical activity. This is measured by a special test that checks your fitness levels. The researchers want to understand if these treatments can make it easier for people with this condition to be more active.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Pauls Stradins Clinical University Hospital
Enrolment target
200
Start
27 Mar 2024

What is this study about?

Imagine your heart as a very important pump. In heart failure with preserved ejection fraction, your heart can still squeeze blood out strongly (that’s the 'preserved ejection fraction' part), but it doesn’t relax as well as it should. This means it struggles to fill up with enough blood before the next pump, which can make you feel tired or short of breath, especially when you try to do physical activities.

This study is looking at a medication called Meldonium. While we don't know much about its general use in the UK yet, researchers are investigating if it could help the heart muscle work more efficiently in people with this specific type of heart failure. They are also combining this with a special exercise programme designed just for you. This is important because regular, appropriate exercise can often help improve heart health.

The main thing the doctors want to find out is how well participants can do physical activities after receiving this treatment. They will measure this using a specialised test that checks how your body uses oxygen during exercise. By seeing if your fitness levels improve, they hope to understand if Meldonium and tailored exercise could be a helpful approach for people living with this heart condition.

Key takeaways

  • This study investigates Meldonium and personalised exercise for heart failure.
  • It aims to improve exercise ability in people with 'heart failure with preserved ejection fraction'.
  • Participation involves medication, tailored exercise, and regular health checks.
  • The study measures changes in your physical activity tolerance.
  • It's for adults (18+) with this specific heart condition, both men and women.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older. There is no upper age limit, so people of all adult ages are welcome to be considered.

This study is for both men and women. Your sex does not affect whether you can take part.

The most important medical requirement is that you have been diagnosed with 'heart failure with preserved ejection fraction'. This means your doctor has confirmed your heart is still pumping blood effectively, but it’s struggling to relax properly.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with 'heart failure with preserved ejection fraction'?
  3. Are you able to attend regular appointments for health checks and tests?
  4. Are you willing to follow a personalised exercise plan?
  5. Are you willing to take a study medication as prescribed?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the medication Meldonium and follow a personalized exercise plan. You would have regular appointments at the study clinic to monitor your health and progress. These visits will include checks by doctors and nurses, and you'll likely have specific tests, including the specialized physical activity test mentioned earlier, to see how your fitness changes.

The study will involve several months of treatment and regular monitoring. You will be given clear instructions on how to take the medication and how to follow your exercise routine at home. The exact number of visits, tests, and the total duration of your participation will be fully explained to you before you make any decisions.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new medication and a personalised exercise programme that could potentially improve your heart health and ability to be active. However, as with any medication, Meldonium may have side effects, and your doctors will monitor you closely for these. There's also no guarantee that the treatment will be effective for you personally. You are completely 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.
  • Unverified
    Latvia

Common questions

What is 'heart failure with preserved ejection fraction'?

It's a type of heart failure where your heart pumps blood out well, but struggles to relax and fill up with enough blood in between beats.

What is Meldonium?

Meldonium is a medication that researchers are studying to see if it can help the heart muscle work better in people with this specific heart condition.

Will I have to exercise?

Yes, a key part of this study involves a personalised exercise programme designed to suit your fitness level and help your heart.

What kind of tests will I have?

You'll have regular health checks and a special test that measures how well your body uses oxygen during physical activity to track your progress.

How long will the study last?

The study will involve several months of treatment and monitoring. The exact duration will be fully explained before you join.

How to find out more

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

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