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Study of dapagliflozin effects in patients hospitalized with acute heart failure

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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 heart failure, a condition where the heart cannot pump blood effectively, leading to symptoms like shortness of breath, fatigue, and fluid buildup in the body. The study will test a medication called dapagliflozin, given as a film-coated tablet, compared to a placebo. The purpose is to determine if starting this medication during hospital stay can improve outcomes for patients who have been stabilized after being admitted for acute heart failure.

The medication or placebo will be taken by mouth once daily for two months. Cardiovascular health and heart failure symptoms will be monitored throughout the study period. This includes tracking any heart-related deaths or worsening of heart failure symptoms that might require additional treatment or hospital readmission.

The study will involve patients who have different levels of heart function, as measured by left ventricular ejection fraction (the amount of blood pumped out by the heart's main chamber). Both patients with and without type 2 diabetes can participate in the study. The medication will only be started after patients have shown initial improvement with standard hospital treatment for their heart failure.

The research process

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

  1. Step 1

    Initial medication phase

    You will receive either dapagliflozin (10 mg film-coated tablet) or a placebo tablet once daily

    This phase starts while you are still in the hospital, between 24 hours and 14 days after your admission

    Before starting the medication, your condition must be stable for at least 12 hours without requiring increased doses of intravenous medications

    You must not have received intravenous heart medications for at least 24 hours before starting the study medication

  2. Step 2

    Treatment duration

    The medication (either dapagliflozin or placebo) will be taken by mouth once daily for 2 months

    You will need to take one tablet each day at approximately the same time

  3. Step 3

    Monitoring period

    Your heart health will be monitored throughout the study period

    The medical team will track any changes in your heart condition

    They will check for signs of heart failure getting worse

    Your kidney function will be regularly assessed through blood tests

  4. Step 4

    Follow-up assessment

    The study will monitor specific health events, including:

    Any hospital readmissions due to heart problems

    Urgent medical visits requiring intravenous medications

    Changes in kidney function

    Blood pressure changes that might require medical attention

Who can join the trial?

9 criteria

  • Must be currently hospitalized for acute heart failure with symptoms such as: - Worsening breathing difficulties or shortness of breath at rest - Increasing tiredness - Rapid weight gain - Worsening swelling in body
  • Must show signs of excess fluid in the body, such as: - Swollen neck veins - Crackling sounds in lungs - Fluid in abdomen - Swelling in legs and ankles - Signs of fluid in lungs on chest X-ray
  • Must be receiving increased heart failure treatment during hospital stay, including: - Higher doses of water pills (diuretics) - Receiving medications through an IV - New medications to help heart function
  • Must have had a heart function test (ejection fraction measurement) within the past 12 months
  • Must have elevated levels of certain heart failure markers (NT-proBNP or BNP) in blood tests during current hospital stay
  • Must be stable for at least: - 12 hours without needing increased IV water pills - 24 hours without needing IV medications for heart function
  • Can participate whether or not you have type 2 diabetes
  • Both men and women can participate
  • Must be an adult (18 years or older)

Who cannot join the trial?

15 criteria

  • Age below 18 years old
  • Known allergy or sensitivity to dapagliflozin (the study medication)
  • Currently pregnant or breastfeeding women
  • Type 1 diabetes (a condition where the body does not produce insulin)
  • Recent heart attack (within the last 30 days)
  • Severe kidney disease (severely reduced kidney function)
  • Current participation in other clinical trials
  • Systolic blood pressure (upper number) below 95 mmHg
  • Life-threatening conditions other than heart failure
  • History of serious allergic reactions to medications
  • Unable to provide informed consent
  • Severe liver disease (severely reduced liver function)
  • History of frequent urinary tract infections (infections in the bladder or urinary system)
  • Plans for major surgery during the study period
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
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Investigated drugs

Dapagliflozin is a medication used to treat heart failure. It belongs to a class of drugs called SGLT2 inhibitors that help improve heart function. The medication is started while patients are still in the hospital after being treated for acute heart failure. It works by helping the body remove excess sugar and fluid through urination, which can help reduce the workload on the heart and improve symptoms of heart failure.

What is already known about the treatment

Dapagliflozin - An oral medication taken in tablet form that belongs to the class of sodium-glucose cotransporter-2 (SGLT2) inhibitors, primarily used in the treatment of heart failure and type 2 diabetes. This medication works by helping the kidneys remove excess glucose and sodium from the body through urine, which reduces the workload on the heart and improves cardiac function. Currently well-established in medical practice with strong clinical evidence supporting its use in treating acute heart failure, particularly when initiated during hospital stays for patients with heart failure symptoms. The medication represents a significant advancement in cardiovascular medicine, as it not only helps manage heart failure symptoms but also reduces the risk of cardiovascular death and hospitalization for heart failure.

Investigated diseases

Acute Heart Failure - A sudden onset condition where the heart cannot pump enough blood to meet the body's needs. This condition develops rapidly, causing fluid to build up in the lungs and other body tissues. The main signs include severe shortness of breath, rapid or irregular heartbeat, and fatigue. Acute heart failure can occur in people who have never had heart problems before, or it can be a sudden worsening of existing chronic heart failure. The condition often requires immediate medical attention as symptoms typically appear or worsen quickly. Fluid retention can cause swelling in the legs and ankles, and patients may experience difficulty breathing, especially when lying down.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517612-29-00Protocol codeD1690C00078Estimated enrolment2 400 patientsSponsorThe Brigham And Women’s Hospital Inc.

sourced from the EU Clinical Trials Register and site verification

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