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Study on Dapagliflozin for Heart Failure Patients After a Heart Attack

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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called dapagliflozin on patients who have experienced a heart attack, also known as an acute myocardial infarction. The study aims to see if dapagliflozin can help improve heart function and structure after a heart attack. Dapagliflozin is a type of medication that is usually used to treat diabetes, but in this study, it is being tested for its potential benefits on the heart. Participants in the study will either receive dapagliflozin or a placebo, which is a substance with no active medication, in addition to their standard heart treatment.

The purpose of the study is to assess how well dapagliflozin works in improving heart function and reducing changes in the heart's structure over a period of six months. This will be done using a test called a transthoracic echocardiography (TTE), which is a type of ultrasound that looks at the heart. The study will monitor changes in the heart's pumping ability and size, as well as other heart-related measurements. Participants will be followed for six months to see how their heart responds to the treatment.

Throughout the study, researchers will also keep track of any side effects or health changes that occur. This includes monitoring for symptoms like dehydration, low blood sugar, infections, and changes in kidney or liver function. The study will help determine if dapagliflozin can be a beneficial addition to standard heart attack treatments, potentially improving recovery and outcomes for patients with heart failure following a heart attack.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, specific heart conditions, and blood pressure levels.

    Written consent is required to participate in the study, which lasts for a 6-month follow-up period.

  2. Step 2

    Randomization and initial assessment

    Participants are randomly assigned to receive either dapagliflozin or a placebo. Dapagliflozin is a medication taken orally.

    Initial assessments include measuring heart function and structure using a test called transthoracic echocardiography (TTE).

  3. Step 3

    Medication administration

    Participants take dapagliflozin or placebo daily. The dosage for dapagliflozin is 10 mg.

    The medication is taken in addition to standard recommended therapy for heart conditions.

  4. Step 4

    Ongoing monitoring

    Throughout the study, participants are monitored for changes in heart function and structure using TTE.

    Participants are also monitored for any adverse events, particularly those related to dapagliflozin, such as symptoms of volume depletion or changes in kidney function.

  5. Step 5

    Final assessment

    At the end of the 6-month period, a final assessment is conducted to evaluate changes in heart function and structure.

    The study aims to assess the effectiveness of dapagliflozin in improving heart function and reducing heart remodeling after a heart attack.

Who can join the trial?

8 criteria

  • Must be at least 18 years old.
  • Must have experienced a type of heart attack called **STEMI** or a very high-risk **NSTEMI**. These are specific types of heart attacks that can be identified by certain changes in heart tests or symptoms like ongoing chest pain or heart failure.
  • Must have **LV dysfunction**, which means the heart's left side is not pumping well, with a measurement called **LVEF** of 45% or less. This is checked after a heart procedure like **PCI** or **angiography**.
  • Must have a kidney function test result called **eGFR** of at least 25 mL/Min per 1.73m². This measures how well the kidneys are working.
  • Must have a **systolic blood pressure** (the top number) greater than 100 mmHg and/or a **diastolic blood pressure** (the bottom number) greater than 70 mmHg before the first dose of the study medication.
  • Must be able to provide written consent, which means agreeing to participate in the study and understanding what it involves.
  • Must be willing to participate in the study for a 6-month follow-up period.
  • Must be part of a national health care system. People who are not part of such a system cannot participate.

Who cannot join the trial?

4 criteria

  • Patients with cardiac failure cannot participate. This means the heart is not pumping blood as well as it should.
  • Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
  • Patients who are not part of the specified clinical trial group cannot participate. This refers to specific categories of patients the study is focusing on.
  • Patients who are considered part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

Dapagliflozin is a medication used in this trial to help improve heart function after a heart attack. It is being tested to see if it can help the heart pump better and reduce changes in the heart's structure when used alongside standard heart treatments.

What is already known about the treatment

Dapagliflozin – Dapagliflozin is administered orally in tablet form. It is currently being studied in clinical trials for its potential benefits in treating cardiac failure, particularly after acute myocardial infarction. The main therapeutic indication is to improve cardiac systolic function and remodeling in patients with left ventricular dysfunction. At the molecular level, dapagliflozin works by inhibiting the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, which helps reduce blood glucose levels and may have beneficial effects on heart function. It is classified as an SGLT2 inhibitor.

Investigated diseases

Cardiac Failure – Cardiac failure, also known as heart failure, is a condition where the heart is unable to pump blood effectively to meet the body's needs. This can result from the heart being too weak or too stiff to fill and pump properly. Over time, the heart's reduced ability to function can lead to symptoms such as fatigue, shortness of breath, and fluid retention. The condition can progress as the heart's pumping capacity continues to decline, potentially affecting other organs due to inadequate blood supply. It often involves changes in the heart's structure and function, such as enlargement of the heart chambers and thickening of the heart walls. Monitoring and managing the condition is crucial to prevent further deterioration of heart function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511882-13-01Protocol codeAPHP211054Estimated enrolment450 patientsSponsorAssistance Publique Hopitaux De Paris

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