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Study of early dapagliflozin treatment to reduce heart damage in patients with acute heart attack and reduced heart pumping function

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What is this study about?

This study focuses on patients with acute myocardial infarction (heart attack) who have reduced heart pumping ability. The research examines the effects of dapagliflozin, a medication that comes as a film-coated tablet taken by mouth. The medication will be tested in patients who have recently experienced a heart attack to see if it can help protect the heart and reduce the size of the damaged heart muscle area.

The study aims to determine whether early treatment with dapagliflozin can provide heart protection and is safe to use in patients who have recently had a heart attack. Researchers will monitor patients for various heart-related complications, including worsening of heart failure, subsequent heart attacks, stroke, or the need for additional heart procedures.

Participants will receive either dapagliflozin or placebo for 3 months. During this time, they will undergo several tests, including cardiac MRI (a detailed heart imaging test) to measure the extent of heart damage. The study will also track other important factors such as changes in body weight, blood pressure, and various blood tests to assess heart and kidney function.

1 Initial treatment

You will receive Forxiga (dapagliflozin) 10 mg tablets that you need to take by mouth

This medication will be administered after you have undergone a heart procedure called primary PCI (a procedure to open blocked arteries in your heart)

The treatment begins within 12 hours of your first heart attack symptoms

2 Hospital monitoring

Your heart function will be examined using an echocardiogram (ultrasound of the heart) within 12 hours of hospital admission

During your hospital stay, your blood pressure will be regularly monitored

Blood tests will be performed to check various factors including: heart function markers, kidney function, and blood count

3 3-month follow-up period

You will continue taking the study medication for 3 months

Your weight changes will be monitored throughout this period

You will undergo a special heart scan called cardiac MRI at the end of 3 months

The MRI will use a contrast agent called gadobutrol to create detailed images of your heart

Additional blood tests will be performed to check heart function markers, kidney function, and blood count

4 Final assessment

At the end of 3 months, your heart function will be evaluated using both cardiac MRI and echocardiogram

Your overall health status will be assessed, including any heart-related events that occurred during the study period

Who Can Join the Study?

  • Must be at least 18 years old
  • Must have STEMI (a type of heart attack where one of the heart’s major arteries is blocked) regardless of which heart artery is affected
  • Must receive primary PCI (emergency procedure to open blocked heart arteries) within 12 hours from when symptoms started
  • Must have TIMI coronary flow grade 0-1 (severely reduced or no blood flow in the affected heart artery) when receiving the primary PCI
  • Must show evidence of:
    • New abnormal heart wall movement
    • LVEF of 40% or less (measurement of how well your heart pumps blood) confirmed by either:
      • Heart imaging during the PCI procedure, or
      • Ultrasound of the heart within 12 hours of hospital admission
  • Must provide written informed consent to participate in the study

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Previous heart attack (myocardial infarction)
  • Known allergy or sensitivity to SGLT-2 inhibitors (the study medication)
  • Current participation in other clinical trials
  • Pregnancy or breastfeeding
  • Severe kidney problems
  • Uncontrolled diabetes (high blood sugar levels)
  • History of stroke in the past 3 months
  • Severe liver disease
  • Life-threatening heart rhythm problems
  • Recent major surgery (within last 30 days)
  • Active bleeding or high risk of bleeding
  • Inability to provide informed consent
  • History of alcohol or drug abuse within past year
  • Any condition that, in the opinion of study doctors, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy

Other Sites

Site Name City Country Status
Ospedale Vito Fazzi Lecce Lecce Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Azienda Sanitaria Locale Della Provincia Di Biella Ponderano Italy
Agbhtsb Oylyhzngfvy Nxrjwuvto Sz Adafgza E Bcuynp E C Agxqvm Azgkinuddld Alexandria Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
19.05.2025

Trial locations

Investigated drugs:

Dapagliflozin is a medication that belongs to a class of drugs called SGLT-2 inhibitors. It works by helping the kidneys remove excess sugar from the blood through urine. In this trial, it is being studied for its potential protective effects on the heart, specifically in patients who have recently had a heart attack and have reduced heart pumping function. The medication may help reduce the size of heart damage and prevent complications after a heart attack.

Investigated diseases:

Acute Myocardial Infarction – A condition that occurs when blood flow to a part of the heart muscle is blocked, causing damage to the heart tissue. The blockage typically happens when a blood clot forms in one of the coronary arteries, which supply blood to the heart. This sudden blockage prevents oxygen-rich blood from reaching a specific area of the heart muscle. Without oxygen, the affected heart muscle begins to die within minutes. The damaged heart tissue may heal by forming scar tissue, which can affect how the heart works. The extent of damage depends on the size of the affected area and how long the blood flow was blocked.

Trial ID:
2025-521481-10-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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