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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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 trial?

8 criteria

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 trial?

15 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
Alexandria, Italy
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Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
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Azienda Ospedaliero-Universitaria Maggiore Della Carita
Novara, Italy

Trial locations

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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.

Dapagliflozin

What is already known about the treatment

Dapagliflozin - An oral medication belonging to the class of SGLT-2 (sodium-glucose cotransporter-2) inhibitors, which is administered as tablets. This medication works by preventing the kidneys from reabsorbing glucose back into the blood, leading to increased glucose excretion in urine, which helps reduce blood sugar levels and has shown beneficial effects on heart function. Currently, it is being investigated in clinical trials for its potential cardioprotective effects in patients with acute myocardial infarction (heart attack) and reduced ejection fraction, particularly focusing on its ability to reduce infarct size and prevent complications during hospitalization. Dapagliflozin is already approved for treating type 2 diabetes and heart failure, and its expanding role in cardiovascular protection represents a significant advancement in medical therapy.

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.