Ongoing, recruitingTherapeutic use (Phase IV)Interventional

The effect of empagliflozin on peripheral microvascular dysfunction in heart failure with preserved ejection fraction

This study is for individuals diagnosed with a specific type of heart failure called 'heart failure with preserved ejection fraction.' This condition means your heart can still pump blood normally, but it's stiff and doesn't fill with enough blood. The research is investigating how a medication called empagliflozin, also known as Jardiance, affects the very small blood vessels in your skin. Researchers are measuring blood flow in these tiny vessels to understand if the medication can improve their function. This is an advanced study, meaning the treatment is already approved for use, and researchers are gathering more information about its effects on the body.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

University Hospital Maastricht

Enrolment target

Start

22 Nov 2022

Heart failure with preserved ejection fraction

What is this study about?

This research is looking at a condition called 'heart failure with preserved ejection fraction.' This type of heart failure is a bit different from what many people think of. It means your heart can still pump blood out to your body with good force. However, the heart muscle itself has become stiff. This stiffness means it can't relax properly and fill up with enough blood between beats. Because of this, your body might not get as much blood as it needs, even if the pumping action seems okay.

The study wants to understand how a specific medicine, empagliflozin (known by the brand name Jardiance), affects the tiny blood vessels, especially those close to the surface of your skin. These small vessels are really important for delivering oxygen and nutrients all over your body. Researchers will be carefully measuring how blood flows through these tiny vessels to see if empagliflozin can help them work better.

This kind of study isn't about testing if a new medicine works for the first time. Empagliflozin is already approved and used for certain conditions. Instead, this study is a 'Phase IV' study. This means researchers are gathering more information about the medicine's effects once it's already available to the public. They want to learn more about how it works in specific situations, like its potential impact on blood flow in small vessels for people with heart failure with preserved ejection fraction.

Key takeaways

Study focuses on a type of heart failure where the heart is stiff but pumps normally.
Investigating how an existing medicine, empagliflozin (Jardiance), affects tiny blood vessels.
Measurements involve skin blood flow tests, blood samples, and questionnaires.
Empagliflozin is an approved medicine; this study aims to learn more about its effects.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.

More specific details about your health condition would be discussed with you by the study team. For example, you would need to have been diagnosed with heart failure with preserved ejection fraction. It's important that your overall health allows you to safely participate.

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 with preserved ejection fraction'?
Are you comfortable potentially taking empagliflozin (Jardiance)?
Are you able to attend study visits for tests and assessments?
Are you generally in good enough health to participate safely?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to the study clinic. During these visits, researchers will perform special measurements of your blood flow in your skin using a technique that measures 'cutaneous vascular conductance' (CVC). This involves using a device called LASCA to look at your skin blood flow. You might also have blood tests to check things like your ketone levels, and you'll be asked to complete questionnaires about your health and quality of life, like the EQ5D-5L.

You would be given the study medication, empagliflozin (Jardiance), to take as directed. The study aims to understand how this medication affects your body over a period of time. There are also other substances listed as 'interventions' (Miochol®-E, NIPRUSS, NovoRapid), but it's likely that only empagliflozin is the main study drug, and the others may be standard treatments or used in specific test procedures.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. A potential benefit of this study is that it could help us understand more about how empowering empagliflozin works in people with heart failure, which might lead to better care in the future. You might also receive closer monitoring of your health during the study. However, there are potential risks, too. Empagliflozin, like all medicines, can have side effects, and some of the tests might be slightly uncomfortable. You will be given a full explanation of all known risks and side effects before you decide to join. Remember, taking part in any clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Netherlands

Common questions

What is 'heart failure with preserved ejection fraction'?

This is a type of heart failure where your heart pumps blood normally, but the heart walls are stiff, making it harder for the heart to fill with enough blood.

What is empagliflozin (Jardiance)?

It's a medicine that is already approved and used to treat certain conditions. This study wants to learn more about its effects on small blood vessels.

What kind of tests will I have?

You'll have special measurements of blood flow in your skin, blood tests, and you'll fill out questionnaires about your health.

Is this a new, unproven treatment?

No, empagliflozin is an approved medicine. This study is gathering more information about how it works in your body.

Can I stop participating if I want to?

Yes, you are free to leave the study at any time, for any reason, without affecting your medical care.