Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Sacubitril-Valsartan in Heart Failure with Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation (PRAISE-MR)

This study, called PRAISE-MR, is investigating how a medicine named Entresto (sacubitril-valsartan) affects people living with heart failure where the heart still pumps well, but has trouble relaxing (heart failure with preserved ejection fraction). These patients also have a leaky heart valve (secondary mitral valve regurgitation). The main goal is to see if Entresto can improve how efficiently the heart uses its blood supply, measured by changes in certain heart pressures over 6 months. Researchers will also look at whether Entresto improves exercise ability, reduces valve leakage, lowers stress hormone levels in the blood, and makes patients feel better in their daily lives. This is a post-market study, meaning Entresto is already approved for other uses.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Ziekenhuis Oost Limburg

Enrolment target

110

Start

11 Oct 2023

Heart failure with preserved ejection fraction Secundary mitral valve regurgitation

What is this study about?

Imagine your heart as a pump that sends blood around your body. Sometimes, even if the pump itself is squeezing blood out well, it can have trouble relaxing properly to fill up again. This condition is called 'heart failure with preserved ejection fraction' (HFpEF). It means your heart isn't working as efficiently as it should, which can make you feel tired, short of breath, or swell up.

Alongside this, some people might also have a 'leaky heart valve', specifically the mitral valve. This valve is like a door between two of your heart's chambers. If it's leaky, some blood can flow backward, making the heart work harder and potentially worsening the heart failure symptoms. This study is looking at a medicine called Entresto, which is already used for other types of heart failure. Researchers want to understand if Entresto can help people who have both these conditions: HFpEF and a leaky mitral valve.

The study aims to see if Entresto can improve how well your heart handles blood pressure and flow over a 6-month period. They will also be checking various things like how much you can exercise, how much the valve is leaking, and how you feel day-to-day. The hope is that Entresto could offer a better way to manage these complex heart problems.

Key takeaways

Study focused on heart failure where the heart pumps well but struggles to relax.
Also includes patients with a leaky heart valve (mitral valve regurgitation).
Investigates the existing heart medicine Entresto (sacubitril-valsartan).
Aims to see if Entresto improves heart function and symptoms over 6 months.
Participation involves taking tablets and having regular check-ups and tests.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old, and there's no upper age limit. The study is open to both men and women.

The most important medical conditions for this study are having heart failure where your heart pumps blood well but struggles to relax (heart failure with preserved ejection fraction) and also having a leaky mitral valve, which is a common problem in people with this type of heart failure.

There might be other specific medical details, perhaps related to other health conditions you have or other medications you take, that would determine if you can join. These will be discussed in detail by the study team to ensure your safety and that the study is right for 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 diagnosed with heart failure where your heart pumps blood well but has trouble relaxing?
Do you also have a leaky mitral valve?
Are you willing to take a study medicine (Entresto) for 6 months?
Can you attend regular clinic visits for tests and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given one of three different doses of the study medicine, Entresto, to take as film-coated tablets. The specific dose you receive would be decided by the study team. You would take this medication for 6 months. Throughout this time, you would have several visits to the clinic.

During these visits, the study team would perform various assessments. These might include tests to measure your heart function, such as echocardiograms (ultrasound scans of your heart) to look at your leaky valve and heart chambers. They might also take blood samples to check certain markers related to your heart health and ask you to do exercise tests to see how your body responds to activity. You would also fill out questionnaires about your symptoms and how you feel in your daily life. Your progress would be monitored closely for the entire 6-month period.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. You might benefit from closer medical monitoring and access to a medication that could improve your heart condition. However, Entresto, like all medicines, can have side effects. These will be fully explained to you by the study team. It's important to remember that 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
Belgium

Common questions

What is 'heart failure with preserved ejection fraction'?

It's a type of heart failure where your heart pumps blood out effectively, but has trouble relaxing to fill up with blood properly.

What does 'secondary mitral valve regurgitation' mean?

This means you have a leaky mitral valve, which is a valve in your heart, and this leakage is happening because of another heart condition, like your heart failure.

Is Entresto a new drug?

No, Entresto is already an approved medicine, but this study investigates its use specifically for people with both preserved ejection fraction heart failure and a leaky mitral valve.

How long would I need to take the study medicine?

You would take the study medicine for a period of 6 months.

Will I know if I'm getting the actual medicine or a dummy pill?

This study is giving everyone different doses of Entresto, so you would be receiving the active medicine, not a dummy pill.