Ongoing, recruitingTherapeutic use (Phase IV)Interventional

EMPagliflozin after Aortic Valve Replacement - the EMPAVR study - a randomized clinical trial

The EMPAVR study is investigating if a medicine called empagliflozin, also known as Jardiance, can help people's hearts recover after having surgery for a condition called aortic stenosis. Aortic stenosis means a major heart valve has narrowed, making the heart work harder. This study wants to find out if taking empagliflozin for 12 months after the valve operation helps to reduce the size of the heart's main pumping chamber. Researchers will use special scans to measure any changes. They will also look at other heart health markers. This is a Phase IV trial, meaning the drug is already approved for other uses, and this study looks at a new potential benefit.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Rigshospitalet

Enrolment target

206

Start

08 Nov 2023

Aortic stenosis

What is this study about?

When you have a condition called aortic stenosis, the main valve leaving your heart becomes narrow. This makes your heart work much harder to pump blood around your body. Over time, the main pumping chamber of your heart can get bigger and thicker as it tries to cope with this extra strain.

Following an operation to fix this (called aortic valve replacement or AVR), your heart should start to recover. This study is testing whether a medicine called empagliflozin, which is also known as Jardiance, can help this recovery process even further. Researchers are particularly interested in seeing if this medicine can help reduce the size of the heart's main pumping chamber over 12 months after your valve replacement surgery.

This is an important study because if empagliflozin helps the heart recover better, it could improve long-term health for people who have had this heart operation. Researchers will closely monitor heart changes using special scans and blood tests, as well as keeping an eye on your general health.

Key takeaways

The EMPAVR study is investigating if Jardiance (empagliflozin) helps heart recovery after aortic valve surgery.
It aims to see if the medicine reduces the size of the heart's main pumping chamber over 12 months.
Participants will receive either Jardiance or a dummy capsule.
The study involves heart scans and blood tests before and after the operation.
It's open to adults aged 18 and over who are having aortic valve replacement.

Who may be eligible?

This study is looking for both men and women, aged 18 years and older, who are going to have an operation to replace their aortic valve because of aortic stenosis.

To join, you would need to be well enough to take part in the study and able to follow the study schedule, including attending appointments before and after your operation.

There will be other medical checks and criteria that the study doctors will go through with you to make sure this particular study is safe and suitable for your individual health situation.

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 due to have an operation to replace your aortic valve because of aortic stenosis?
Are you generally well enough to attend hospital appointments and take daily medication?
Do you understand that you might receive active medication or a dummy pill?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a full assessment before your aortic valve replacement operation. After your operation, you would start taking either the study medication (Jardiance) or a dummy capsule (placebo), which looks the same but contains no active drug, every day for 12 months. You wouldn't know whether you were taking the medicine or the dummy capsule.

Throughout these 12 months, you would have several follow-up visits. These visits will include various tests, such as heart scans (CT scans and echocardiograms) to measure your heart's size and function, and blood tests to check certain heart health markers. The study will last a total of 12 months from when you start taking the medication.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study could be that empagliflozin might help your heart recover better after surgery, though this is what the study is trying to find out. There are also potential risks associated with taking any medication, and the study team will explain all known possible side effects of empagliflozin. You can ask any questions you have about these. Throughout the study, your health will be carefully monitored by the medical team. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual hospital 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
Denmark

Common questions

What is aortic stenosis?

Aortic stenosis is a condition where the main valve that lets blood leave your heart becomes narrow. This makes your heart work harder to pump blood.

What is empagliflozin (Jardiance)?

Empagliflozin, sold as Jardiance, is a medicine that is already approved for other conditions like type 2 diabetes and heart failure. This study is looking at a new potential use for it.

Will I definitely get the active drug?

No. In this study, you would be randomly assigned to receive either empagliflozin or a dummy capsule (called a placebo). This helps researchers fairly assess the drug's effects.

What does a 'heart scan' involve?

Heart scans in this study include CT scans and echocardiograms (which use sound waves). These are common medical tests that help doctors look closely at your heart's structure and how well it's working.

How long will I take part in the study?

If you join, you would take the study medication for 12 months after your aortic valve replacement operation, with several check-up visits during that time.