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Efficacy and Safety of Fixed‑Dose Combination of Dapagliflozin, Bisoprolol Fumarate, and Eplerenone vs Usual Care in Hospitalized Acute Heart Failure Patients

Verified siteInvestigationalNo 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 Heart Failure, a condition where the heart cannot pump blood as well as it should, leading to symptoms such as shortness of breath, fatigue, and swelling in the legs. Participants will receive a single pill that contains three medicines: dapagliflozin, which helps the kidneys remove extra sugar and fluid; bisoprolol fumarate, a type of beta‑blocker that slows the heart rate and reduces its workload; and eplerenone, which blocks a hormone that can cause fluid buildup. This approach is called a Fixed-dose combination, meaning the drugs are combined into one capsule instead of taking several separate tablets.

The purpose of the trial is to see whether this combined‑pill strategy can lower the number of serious heart problems and cardiovascular death compared with usual care, where each medicine is given separately. After being admitted to the hospital for an acute episode of heart failure, participants will be randomly assigned to either the combined pill or the standard treatment plan. They will take the assigned medication for several months while doctors regularly check their health, record any hospital visits for worsening heart failure, and note any deaths related to heart disease.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization to Treatment Group

    After joining the study you are randomly placed into one of two groups. One group receives a fixed‑dose combination (FDC) pill that contains several heart‑failure medicines together. The other group continues with the standard medicines that your doctor normally prescribes, called usual care.

  2. Step 2

    Baseline Assessments

    Before starting any study medication you undergo a series of assessments. These include a review of your medical history, a physical examination, and laboratory tests to establish your health status at the beginning of the trial.

  3. Step 3

    Start of Study Medication

    If you are assigned to the fixed‑dose combination (FDC) arm, you receive a hard‑gelatin capsule taken by mouth. The capsule may contain one of several possible combinations:

    - Dapagliflozin 10 mg together with bisoprolol fumarate 5 mg and eplerenone 25 mg (total 25 mg capsule).

    - Dapagliflozin 10 mg together with bisoprolol fumarate 5 mg and eplerenone 50 mg (total 50 mg capsule).

    - Dapagliflozin 10 mg together with bisoprolol fumarate 10 mg (total 10 mg capsule).

    - Dapagliflozin 10 mg together with eplerenone 25 mg (total 25 mg capsule).

    - Dapagliflozin 10 mg together with eplerenone 50 mg (total 50 mg capsule).

    If you are assigned to the usual care arm, you receive the individual medicines prescribed by your physician, which may include the same active substances but taken as separate tablets.

  4. Step 4

    Daily Medication Intake

    You take the assigned capsule(s) by mouth once each day, at the same time each day, unless your doctor advises a different schedule. The dose printed on the capsule label matches the amounts listed in the previous step.

  5. Step 5

    Scheduled Follow‑Up Visits

    Throughout the trial you attend regular follow‑up visits that are arranged by the study team. During each visit you undergo a brief physical check, report any new symptoms, and may have additional laboratory tests to monitor how the medication is affecting your condition.

  6. Step 6

    Monitoring for Events

    The study records any occurrences of heart failure worsening, hospitalizations for heart failure, or death. You are asked to inform the study staff promptly if you experience any of these events or if you notice side effects such as dizziness, low blood pressure, or changes in kidney function.

  7. Step 7

    Continuation Until Study End

    You continue taking the study medication and attending follow‑up visits until the trial reaches its planned end date of June 1 2029, or until a predefined event (for example, a heart‑failure hospitalization or death) occurs, whichever happens first.

  8. Step 8

    Final Assessment and Study Closure

    At the conclusion of the trial you undergo a final assessment that includes a physical examination and laboratory tests. The data collected throughout the study are then used to compare the outcomes of the fixed‑dose combination (FDC) strategy with those of usual care.

Who can join the trial?

8 criteria

  • Be an adult aged 18 to 85 years, any gender or ethnic background.
  • Sign a written consent form agreeing to join the study.
  • Be in the hospital because of a new worsening of heart failure with shortness of breath (called dyspnea) at rest or during activity, plus at least two of the following: swelling in the legs or feet (peripheral edema), crackling sounds in the lungs when a doctor listens (rales), fluid seen on a chest X‑ray (pulmonary congestion), or a high pressure in the neck veins (elevated jugular venous pressure).
  • Have a high level of heart‑failure blood test called NT‑proBNP (at least 1600 pg/mL) or BNP (at least 400 pg/mL). If you also have atrial fibrillation (an irregular heartbeat), the thresholds are higher: NT‑proBNP ≥ 2400 pg/mL or BNP ≥ 600 pg/mL.
  • Be hemodynamically stable, meaning you have not needed strong IV medicines that raise blood pressure, help the heart pump, widen blood vessels, or remove fluid (vasoactive intravenous vasopressors, inotropes, vasodilators, IV diuretics) in the 24 hours before checking, and you are enrolled between 48 hours and 10 days after admission.
  • Have no medical reason that would stop you from taking the study medicines: an SGLT2 inhibitor, a beta‑blocker, or a mineralocorticoid receptor antagonist (contraindications to these drugs).
  • Have a blood pressure of at least 100 mm Hg (the top number, called systolic blood pressure) or a heart rate of at least 60 beats per minute (heart rate) when checked.
  • Have a left ventricular ejection fraction (LVEF) less than 50% measured by an echo or similar test within the past year (LVEF shows how well the main pumping chamber of the heart works).

Who cannot join the trial?

4 criteria

  • Type 1 diabetes mellitus – a condition where the body cannot make insulin, the hormone that controls blood sugar.
  • Serum potassium (K+) level lower than 3.2 mmol/L or higher than 5.0 mmol/L at the start – potassium is a mineral that helps the heart and muscles work properly.
  • Serum sodium (Na+) level lower than 130 mmol/L or higher than 150 mmol/L at the start – sodium is a mineral that helps control fluid balance in the body.
  • Kidney disease with an estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m² or less, or a history of dialysis – eGFR measures how well the kidneys filter waste; dialysis is a treatment that does the work of the kidneys.
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Investigated drugs

  • Dapagliflozin

    is a pill that helps the kidneys get rid of extra sugar and fluid from the body. By removing this fluid, it reduces the strain on the heart and is used to treat people with heart failure.

  • Bisoprolol

    is a beta‑blocker medicine that slows down the heart’s beating speed and lowers the force of each beat. This makes the heart work easier and helps prevent worsening of heart failure.

  • Eplerenone

    is a medication that blocks a hormone called aldosterone. It helps the body eliminate excess salt and water, which lowers blood pressure and protects the heart from damage.

  • Fixed‑Dose Combination (FDC) therapy

    is a single capsule that contains two or three of the above medicines together. Combining them in one pill is meant to simplify the treatment plan, make it easier for patients to take their medicines, and improve how well the treatment works.

  • Guideline‑Directed Medical Therapy (GDMT)

    refers to the standard set of heart‑failure medicines that doctors are recommended to prescribe, based on clinical guidelines. In this trial, GDMT includes the three drugs but they are given as separate pills rather than in one combined capsule.

  • Usual care

    is the normal treatment that doctors choose for each patient outside of the study protocol. It may include any heart‑failure medicines the doctor thinks are best, and it does not require the use of the fixed‑dose combination capsule.

What is already known about the treatment

  • Dapagliflozin

    This medication is taken orally in hard‑gelatin capsules that dissolve in the stomach. It is an approved drug and widely described in medical literature as a sodium‑glucose co‑transporter‑2 (SGL2) inhibitor used for type 2 diabetes and for reducing the risk of worsening heart failure. It works by blocking the SGL2 protein in the kidneys, causing excess glucose and sodium to be excreted in the urine, which helps lower blood sugar and reduces fluid overload on the heart. Pharmacologically it belongs to the class of SGL2 inhibitors.

  • Bisoprolol fumarate

    Bisoprolol fumarate is administered orally as a hard‑gelatin capsule that is swallowed whole. It is an established, guideline‑recommended drug for high blood pressure, angina, and chronic heart failure, with extensive evidence in clinical studies. It selectively blocks beta‑1 receptors in the heart, slowing the heart rate and lowering the heart’s workload, which improves heart function. It is classified as a selective beta‑blocker.

  • Eplerenone

    Eplerenone comes in oral hard‑gelatin capsules that are taken by mouth. It is an approved medication for treating high blood pressure and for improving outcomes in patients with heart failure, and it is well documented in the medical literature. It works by specifically blocking mineralocorticoid (aldosterone) receptors, preventing aldosterone‑driven fluid retention and heart remodeling. Its pharmacological class is a selective mineralocorticoid receptor antagonist.

Investigated diseases

Heart Failure - Heart Failure is a condition in which the heart cannot pump blood as well as it should. It often starts with the heart becoming weaker or stiff, leading to fluid buildup in the lungs and other parts of the body. Over time, symptoms such as shortness of breath, swelling of the legs, and fatigue may become more frequent. The condition can progress from mild difficulty with exertion to needing rest for basic activities. Episodes of worsening symptoms, called decompensation, can occur and may require hospital care. The disease course varies, but it generally involves a gradual decline in heart function.
Trial detailsLast updated 14 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2026-526510-90-00Protocol codeS005207-229Estimated enrolment901 patientsSponsorInstitut De Recherches Internationales Servier IRIS

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