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Effect of Continuing vs Stopping Dapagliflozin (with other drug combinations) on 30‑Day Cardiovascular Outcomes in Heart Failure Patients Undergoing Cardiac Surgery

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

The study focuses on people with heart failure, a condition where the heart cannot pump blood as well as it should. Participants must have been taking a medication that belongs to the SGLT-2 inhibitor class, such as dapagliflozin or empagliflozin, for at least four weeks before a planned operation on the heart. The purpose of the study is to compare the effects of continuing versus stopping these medicines before heart surgery on heart‑related outcomes after the operation.

In the trial, participants are randomly assigned to either keep taking the medication right up to the morning of the surgery or to stop it three days before the procedure. The operation is performed using cardiopulmonary bypass, a technique that temporarily takes over the work of the heart and lungs. After surgery, patients are monitored for about a month to see whether they develop problems such as damage to the heart muscle measured by an increase in high-sensitivity troponin I, a blood test that shows heart injury, or experience low cardiac output syndrome, which means the heart is not pumping enough blood. Other complications that are checked include a rare condition called euglycaemic ketoacidosis (a buildup of acids despite normal blood sugar), acute renal failure (sudden kidney problems) assessed using the KDIGO scoring system, need for additional hospital stays for heart failure, and overall survival. The follow‑up period lasts 30 days after the surgery, during which length of hospital stay and quality of life are also recorded.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    After joining the study, you will sign an informed consent form and provide basic health information.

    A baseline evaluation will be performed, including a review of your heart failure status, current medications, and a quality of life questionnaire using the eq5d tool.

  2. Step 2

    Randomization

    You will be assigned by the study system to one of two groups: the continuation group or the discontinuation group.

    The assignment determines how the study medication, a sglt‑2 inhibitor, will be managed before surgery.

  3. Step 3

    Pre‑operative medication management

    If you are in the continuation group, you will keep taking your prescribed sglt‑2 inhibitor every day until the morning of the scheduled cardiac surgery.

    If you are in the discontinuation group, you will stop the sglt‑2 inhibitor three days before the day of surgery.

    The study medications may be one of the following, taken by mouth:

    dapagliflozin: 10 mg once daily.

    empagliflozin: 25 mg once daily.

    If your prescription includes a combination product with metformin, the metformin dose (10 mg for dapagliflozin combo or 25 mg for empagliflozin combo) will be taken as directed, but the sglt‑2 component follows the continuation or discontinuation rule.

  4. Step 4

    Pre‑operative day

    On the day before surgery, you will take the usual morning dose of any remaining medications.

    If you belong to the continuation group, you will also take the scheduled dose of the sglt‑2 inhibitor in the morning.

  5. Step 5

    Surgery

    You will undergo the scheduled cardiac surgery with cardiopulmonary bypass.

    The study does not require any additional actions from you during the operation.

  6. Step 6

    Post‑operative monitoring

    After surgery, hospital staff will monitor you for the primary outcomes, including heart muscle injury, low cardiac output, rehospitalisation for heart failure, and survival up to 30 days.

    Blood tests for high‑sensitivity troponin i and other routine labs will be performed during the first 48 hours and throughout the first week.

    The timing of when you may restart the sglt‑2 inhibitor will be recorded.

  7. Step 7

    Resumption of sglt‑2 inhibitor

    Once the clinical team determines it is safe, you will restart the sglt‑2 inhibitor.

    The exact number of days after surgery before restarting will be noted as part of the study data.

  8. Step 8

    Discharge and follow‑up

    You will receive discharge instructions and a schedule for follow‑up visits.

    A quality of life questionnaire (eq5d) will be completed again on day 30 after surgery.

    The study will collect information on any rehospitalisation, heart failure symptoms, kidney function, and any occurrence of euglycaemic ketoacidosis within the first 30 days.

  9. Step 9

    Final assessment at 30 days

    At the 30‑day visit, the study team will review all outcome measures, including mortality, cardiac events, and overall health status.

    The data will be used to compare the two groups and determine the impact of continuing versus stopping the sglt‑2 inhibitor before surgery.

Who can join the trial?

5 criteria

  • Be an adult who is planning to have heart surgery that uses a machine called a cardiopulmonary bypass to take over the work of the heart and lungs during the operation.
  • Have been taking a medicine class called SGLT-2 inhibitors (these drugs help the heart and kidneys work better) for at least four weeks, and may also be taking the diabetes medicine metformin at the same time.
  • Have heart failure with a measurement called left ventricular ejection fraction that is less than 50% (this number shows how well the main pumping chamber of the heart is squeezing blood).
  • Have signed the informed consent form, which means you agree to join the study after understanding what it involves.
  • Be enrolled in a social security scheme or a similar health‑coverage program.

Who cannot join the trial?

18 criteria

  • Started the drug class called SGLT‑2 inhibitor (a medication that helps the heart and kidneys) less than 4 weeks ago, or using a SGLT‑2 inhibitor that is not empagliflozin or dapagliflozin.
  • Using a machine that helps pump blood (called mechanical circulatory support) before the surgery.
  • Having a heart transplant or receiving an implanted device that assists the left side of the heart (called a Left Ventricular Assist Device (LVAD)).
  • Having long‑term kidney disease with a glomerular filtration rate (GFR) lower than 25 mL/min/1.73 m², which means the kidneys are working very poorly.
  • Having any of the following serious, sudden health problems that could make it unsafe to keep taking the SGLT‑2 inhibitor at the time of enrollment:
    • Shock or very low oxygen to body tissues, shown by a blood lactate level higher than 3 mmol/L in the past week.
    • Acute kidney injury (sudden worsening of kidney function) in the past week, classified as KDIGO stage 2 or higher.
    • Severe liver failure, indicated by a blood factor V level below 50 %.
    • Recent heavy alcohol poisoning (within the past week) or ongoing alcohol use disorder without being in withdrawal.
    • Having heart failure where the heart’s pumping ability (called ejection fraction) is 50 % or higher, meaning the heart’s function is relatively preserved.
    • Being pregnant or breastfeeding.
    • Having a medical reason that makes SGLT‑2 inhibitors unsafe, such as:
      • Type 1 diabetes (a condition where the body does not make insulin).
      • Known allergy or severe reaction (hypersensitivity) to the medication.
      • Chronic kidney disease with an estimated GFR (eGFR) lower than 25 mL/min/1.73 m².
      • Being a minor (under the legal adult age) or an adult who is under legal protection (such as guardianship, trusteeship, or court‑ordered protection).
      • Not being able to understand or speak French.
      • Already taking part in another research study that involves an experimental treatment (an interventional study).
      • Having surgery scheduled to occur in less than 3 days.
      • Having surgery for an active infection of the heart valves (called endocarditis) that has been present for less than 3 months.
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Investigated drugs

  • Metformin and Dapagliflozin

    is a combination pill that contains two medicines. Metformin helps lower blood sugar by improving how the body uses insulin. Dapagliflozin belongs to a class called SGLT‑2 inhibitors; it works by helping the kidneys remove extra sugar in the urine. Together, they are used to treat type 2 diabetes and have been shown to help people with heart failure feel better.

  • Dapagliflozin

    is a single‑ingredient drug that belongs to the SGLT‑2 inhibitor class. It lowers blood sugar by causing the kidneys to excrete more glucose in the urine. In addition to controlling diabetes, dapagliflozin can improve heart function and reduce the risk of heart‑related problems in patients with heart failure.

  • Metformin and Empagliflozin

    is a combination pill that includes metformin, which helps the body use insulin more effectively, and empagliflozin, another SGLT‑2 inhibitor. Empagliflozin works like dapagliflozin by making the kidneys eliminate extra sugar. This combo is used for type 2 diabetes and also provides heart‑protective benefits for people with heart failure.

  • Empagliflozin

    is a single‑ingredient SGLT‑2 inhibitor. It lowers blood sugar by increasing the amount of glucose the kidneys remove in the urine. Empagliflozin is also known to improve outcomes for patients with heart failure, helping to reduce hospitalizations and improve overall heart health.

What is already known about the treatment

  • Metformin and Dapagliflozin

    The medication is taken as an oral tablet that is swallowed with water. It is an approved drug combination used mainly for type 2 diabetes and is also known to help people with heart failure. Metformin works by lowering the amount of sugar the liver releases, while dapagliflozin blocks a kidney protein (SGLT‑2) that re‑absorbs sugar, causing more sugar to leave the body in urine. The product belongs to the biguanide class (metformin) combined with an SGLT‑2 inhibitor class (dapagliflozin).

  • Dapagliflozin

    This drug is administered orally as a tablet that is swallowed whole. It is an approved medication for type 2 diabetes and is also used to treat heart failure and to protect the kidneys. Dapagliflozin blocks the SGLT‑2 transporter in the kidney, which reduces sugar re‑absorption and helps the body get rid of excess glucose and fluid. It is classified as an SGLT‑2 inhibitor.

  • Metformin and Empagliflozin

    The combination comes in oral tablet form that is taken by mouth with water. It is approved for treating type 2 diabetes and is also used to lower the risk of heart failure complications. Metformin decreases liver glucose production, and empagliflozin inhibits the kidney SGLT‑2 protein, leading to more glucose being excreted in urine. The product combines a biguanide (metformin) with an SGLT‑2 inhibitor (empagliflozin).

  • Empagliflozin

    This medication is provided as an oral tablet that patients swallow with water. It is an approved treatment for type 2 diabetes and for reducing heart failure hospitalizations. Empagliflozin works by blocking the SGLT‑2 transporter in the kidneys, which helps the body remove excess sugar and fluid through urine. It belongs to the SGLT‑2 inhibitor class.

Investigated diseases

Heart failure - Heart failure is a condition where the heart cannot pump blood as well as it should. This leads to a buildup of fluid in the lungs and other parts of the body. Over time, people may notice shortness of breath, swelling in the legs, and feeling tired more easily. The heart’s pumping ability can gradually decline, causing the symptoms to become more frequent. As the condition progresses, everyday activities may become harder to perform.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524395-30-00Protocol codeRC31/25/0443Estimated enrolment458 patientsSponsorCentre Hospitalier Universitaire De Toulouse

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