Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

The impact of Empagliflozin on Left atrIal Volume and the feasibility of using Fitbit and mHealth to prescribe Exercise in non-diabetic Pre- Heart Failure (ELIVE pre-HF Study)

This study, called ELIVE pre-HF, is testing a medicine called Empagliflozin (also known as Jardiance) for people in the very early stages of heart weakening, before they have full heart failure. The main goal is to see if this medicine can reduce the size of the heart's left upper chamber (left atrium) over six months. Researchers will use special scans called CMR (like an advanced MRI for the heart) to measure this. The study also wants to find out if using fitness trackers, like Fitbits, can help people exercise more effectively to support their heart health. This research is for people who don't have diabetes but are experiencing early signs of heart problems.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

University College Dublin

Enrolment target

100

Start

25 Mar 2024

Pre-Heart Failure (Non-diabetic)

What is this study about?

This study is called ELIVE pre-HF, and it's looking into ways to help people whose hearts are starting to show signs of weakness, even before they officially have heart failure. This early stage is sometimes called 'pre-heart failure'. The exciting part is that the study is focusing on people who don't have diabetes, as this medicine is often used for diabetes or established heart failure, but its benefits for people without diabetes in this early stage are still being explored.

The main aim of the study is to see if a medication called Empagliflozin (you might know it as Jardiance) can help reduce the size of a specific part of the heart called the left atrium. This chamber can get bigger when the heart is working harder than it should. Doctors will use a detailed heart scan, similar to an MRI, to measure these changes over six months. They'll also be looking at other important heart measurements and blood tests to get a full picture of how the medicine might be working.

Another interesting part of this study is that it's also looking at whether technology, like fitness trackers (such as a Fitbit), can be a good way to encourage people to exercise more to boost their heart health. Exercise is really important for a healthy heart, and the researchers want to see if these tools can make it easier for people to be active. By doing this research, doctors hope to find better ways to support people in the early stages of heart problems and potentially prevent them from getting worse.

Key takeaways

This study is for people with early signs of heart problems, without diabetes.
It tests if a medicine called Jardiance can shrink a part of the heart.
Researchers will use special heart scans and blood tests to check progress.
The study also looks at using Fitbits to encourage more exercise.
Participation lasts six months and involves medication and regular check-ups.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. There's no upper age limit, so people of many ages can take part. The study is open to both men and women.

Since the study is about 'pre-heart failure', you would need to have been diagnosed with this condition, which means your heart is showing some signs of weakening but isn't in full heart failure yet. It's important that you do not have diabetes, as this study specifically wants to understand the effects of the medication in non-diabetic individuals.

There will be other detailed medical checks to make sure the study is safe and right for you. These checks will ensure you meet all the specific requirements set by the researchers, which your doctor will discuss with you.

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 told you have 'pre-heart failure'?
Do you NOT have diabetes?
Are you able to attend regular hospital appointments for scans and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be taking a medicine called Jardiance (Empagliflozin) for six months. You would need to attend several appointments for assessments. These will include a special heart scan, called a CMR, at the beginning of the study and again after six months, to measure changes in your heart. You would also have blood tests at these visits.

Throughout the study, you might be asked to use a fitness tracker, like a Fitbit, to help encourage physical activity. The total duration of your active involvement in the study, including taking the medication and attending appointments, will be six months. There might be some follow-up beyond this, but the core assessment period is six months.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as receiving a medication that could improve your heart health at a crucial early stage, and closer monitoring of your heart condition. You would also contribute to valuable research that could help many other people in the future. As with any medication, there can be potential risks or side effects from Empagliflozin, which your doctor will explain in detail. There are also risks associated with the hospital visits and procedures like blood tests, though these are generally small. You are 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.

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Unverified
Ireland

Common questions

What is 'pre-heart failure'?

Pre-heart failure means your heart is showing early signs of weakness or stress, but you don't have all the symptoms of full heart failure yet. It's an important stage to try and prevent further problems.

What is Empagliflozin (Jardiance) usually used for?

Empagliflozin is a medicine usually prescribed for people with type 2 diabetes, or for certain types of heart failure, to help manage their condition and protect their heart and kidneys.

What is a CMR scan?

A CMR scan is a special kind of heart scan, like an MRI, that takes very detailed pictures of your heart. It helps doctors see its size, structure, and how well it's working without using radiation.

Will I have to pay for the Fitbit or medicine?

No, if you are accepted into the study, the study supplies like the medication and any provided fitness tracker would be covered by the study.

What if I decide I don't want to continue with the study?

You can leave the study at any time, for any reason. Your decision will not affect your relationship with your doctors or your future medical care.