AuthorisedTherapeutic use (Phase IV)Interventional

Effects of sodium-glucose cotransporter 2 inhibition on the mechanisms of heart failure with preserved ejection fraction

This study is investigating a medicine called Forxiga (10 mg tablets) in people with a specific type of heart failure where the heart's pumping action still seems normal, but it struggles to fill with blood properly. This is known as 'heart failure with preserved ejection fraction'. The researchers want to understand exactly how Forxiga affects the heart. They'll be looking at things like how well the heart muscle relaxes and how stiff it is, as well as changes in the heart's size and shape. They will also examine how blood flows through the heart and look at tiny changes in heart cells and surrounding tissues. This research is in its final stage (Phase IV), meaning the drug is already approved and the study is gathering more detailed information.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Fundación para la Innovación en Biomedicina, Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon

Enrolment target

Start

31 Jan 2025

Heart failure with preserved ejection fraction

What is this study about?

Imagine your heart as a pump that sends blood around your body. When you have heart failure, this pump isn't working as well as it should. There are different types of heart failure. This study is focusing on a type called 'heart failure with preserved ejection fraction.' This means that even though your heart can still pump out a normal amount of blood with each beat, it has trouble relaxing and filling up with blood properly between beats. This stiffness or difficulty relaxing means it's not as efficient as it should be.

This study is looking at a medicine called Forxiga, which is already used to treat heart failure. Researchers want to understand exactly how this medicine helps the heart in people with this specific type of heart failure. They will use very advanced tests to see how the heart muscle moves, fills, and pumps. They'll also look at the make-up of the heart at a very detailed level, examining heart cells and the tissues around them. Understanding these changes will help doctors gain a much clearer picture of how Forxiga works and why it helps people feel better.

The main goal is to learn more about the heart's pumping and relaxing abilities and how Forxiga influences these. They'll also check for changes in the heart's size and shape, how blood flows inside the heart chambers, and even tiny changes in heart cells and the surrounding support structures. This deep dive into how Forxiga works will provide valuable information for doctors treating patients with heart failure with preserved ejection fraction.

Key takeaways

Study examines Forxiga's effects on heart failure with 'preserved ejection fraction'.
Focuses on how the heart muscle functions, relaxes, and its structure.
Uses advanced imaging and cell analysis to understand the drug's action.
Participants will take Forxiga 10 mg tablets.
Aims to improve understanding for future patient care.
You can stop participating at any time.

Who may be eligible?

To join this study, participants need to be at least 18 years old. There's no upper age limit, so people of many different ages can take part. Both men and women are welcome to participate.

Because this study is looking specifically at heart failure with preserved ejection fraction, potential participants would need to have this diagnosed condition. The medical team will check your health records and perform some tests to make sure you fit all the necessary criteria for the study.

It's important to understand that there might be other specific health conditions or medications that would prevent someone from joining, even if they meet these general age and sex requirements. The study team will explain all the details during the screening process.

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 generally willing to take study medication (Forxiga)?
Are you able to attend regular appointments for tests and check-ups?
Are you comfortable with various heart scans and blood tests being part of the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given Forxiga 10 mg film-coated tablets to take as directed by the study team. You would have regular appointments at the study clinic. These visits would involve various tests to check your heart health and how the medicine is affecting you.

Some of these tests might include special scans like Cardiac MRI, which takes detailed pictures of your heart, and echocardiograms (ultrasounds of your heart) to look at blood flow. You might also have blood tests and other assessments to monitor your heart cells and tissues.

The study would involve a period of taking the medication and attending these check-up appointments. The total duration of your participation would be explained fully by the study team, along with details about how often you would need to visit.

Potential risks and benefits

Taking part in this study could offer several potential benefits, such as receiving close medical attention for your heart failure and access to a medication specifically being studied for your condition. You would also be contributing to medical knowledge that could help many others with similar heart conditions in the future. However, like all medications, Forxiga can have side effects. The study team will explain all known side effects, which might include things like urinary tract infections or increased urination. There's also the chance that the treatment might not work for you, or that the tests involved could cause minor discomfort. You are always 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
Spain

Common questions

What is 'heart failure with preserved ejection fraction'?

This is a type of heart failure where your heart can still pump blood out with normal strength, but it struggles to relax and fill properly between beats.

What is Forxiga?

Forxiga is a medicine that is already approved and used to treat certain conditions, including a type of heart failure. This study wants to understand exactly how it helps the heart.

Will I get the actual medicine or a dummy pill?

This study is giving everyone Forxiga 10 mg tablets, so there's no dummy pill involved. It's about understanding how the active medicine works.

What kind of tests will I have?

You might have heart scans like MRI and echocardiograms, blood tests, and other check-ups to see how your heart is responding to the medicine.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any point, and it won't affect your regular medical care.