AuthorisedTherapeutic use (Phase IV)Interventional

Early use of dapagliflozin in patients with acute myocardial infarction and reduced ejection fraction: the randomized ARMYDA-9 Dapagliflozin trial

This research trial, called ARMYDA-9 Dapagliflozin, is investigating if an existing medicine, Forxiga (dapagliflozin), can make a difference for people who have just experienced a heart attack. Doctors want to see if giving this drug early can help reduce the amount of damage to the heart muscle. They will measure this damage using a special scan called a cardiac MRI three months after a heart attack. The study will also look at other important things, like how it affects your overall health, whether you need to go back into hospital, and other heart-related problems. This is a Phase IV trial, meaning the drug is already approved for other uses but researchers are exploring new benefits.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Enrolment target

140

Start

22 Aug 2025

Acute Myocardial Infarction

What is this study about?

This research study, called ARMYDA-9 Dapagliflozin, is being done to understand if a medicine named Forxiga, also known by its active ingredient dapagliflozin, can help people who have recently had a 'acute myocardial infarction', which is the medical term for a heart attack. When you have a heart attack, part of your heart muscle can get damaged. This study wants to find out if taking Forxiga shortly after a heart attack can limit this damage.

To do this, researchers will compare two groups of patients. One group will receive Forxiga, and the other will not. The main way they will check for heart damage is by using a special scan called a cardiac MRI. This scan will be done about three months after the heart attack. The doctors will measure the size of the damaged area in the heart muscle from these scans. This measurement will help them understand if Forxiga is having a positive effect.

The study will also look at many other important things, like your general health, if you need to go back into hospital for heart problems, if you have another heart attack or stroke, and even changes in your body weight. By carefully looking at all these aspects, the researchers hope to learn if Forxiga could become a useful treatment for people recovering from a heart attack.

Key takeaways

This study investigates if Forxiga can help heart attack patients.
It aims to reduce heart muscle damage after a heart attack.
Heart damage will be measured using an MRI scan after three months.
The study also tracks overall health and other heart-related events.
Participation involves taking the study drug and having follow-up appointments and scans.
It's a 'blinded' study, so you won't know if you're getting the active drug.

Who may be eligible?

This study is open to both men and women, aged 18 and over, who have recently had a heart attack and whose heart currently isn't pumping as strongly as it should (doctors call this 'reduced ejection fraction').

There might be other specific health requirements or conditions that would mean you can or cannot join the study. If you've had a heart attack recently and are interested, it's best to discuss it with your doctor.

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.

I am 18 years old or older.
I have recently had a heart attack (acute myocardial infarction).
My heart's pumping ability is not as strong as it should be (reduced ejection fraction).
I am prepared to attend follow-up appointments and have a heart MRI scan.

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given the study drug, Forxiga, after your heart attack. You will have a special heart scan, called a cardiac MRI, about three months after your heart attack. This scan uses a special dye injected into your arm to help doctors see your heart muscle clearly. This scan helps measure any damage to your heart.

You will also have regular check-ups and tests, including blood tests and possibly other heart scans like an echocardiogram (a type of ultrasound for your heart). The doctors will also keep track of your general health, any hospital visits, and changes in your weight and blood pressure. The study will mainly follow your progress for three months, but the team will also check for any major health events during that time.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that Forxiga might help reduce damage to your heart after a heart attack, which could lead to better long-term health. However, there's no guarantee that you will personally benefit. Forxiga, like all medications, can have side effects. Your study doctor will explain all known side effects and monitor you closely for any issues. You have the full right 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
Italy

Common questions

What is a 'heart attack' in simple terms?

A heart attack happens when the blood flow to a part of your heart is blocked, often by a blood clot. This can damage the heart muscle.

What is Forxiga and what is it usually used for?

Forxiga is a medicine that helps the body remove excess sugar, often used to treat type 2 diabetes and sometimes certain heart conditions or kidney disease.

What is a cardiac MRI?

A cardiac MRI is a special scan that uses magnets and radio waves to create detailed pictures of your heart. It helps doctors see how well your heart is working and if there's any damage.

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

This study is 'blinded', which means neither you nor the doctors will know if you are receiving Forxiga or not. This helps ensure the study results are fair and accurate.

How long will I be in this study?

The main part of the study will follow your health for about three months after your heart attack, with a special heart scan at the end of that period.