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Evaluating the Effect of Vicadrostat and Empagliflozin Combination Compared to Empagliflozin Alone in Patients with Heart Failure and Reduced Left Ventricular Function

Fast replyRegistered drugNo placebo
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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 investigating the treatment of heart failure, specifically for people who have a weak pumping function of the left side of the heart (where the left ventricular ejection fraction is less than 40%). Heart failure is a condition where the heart cannot pump blood effectively enough to meet the body's needs, which can cause symptoms like shortness of breath, fatigue, and swelling in the legs.

The study will test whether a medication called vicadrostat (BI 690517) when used in combination with another medication called empagliflozin is better than empagliflozin alone (with placebo) for treating heart failure. The purpose of the study is to determine if this combination therapy can reduce the occurrence of cardiovascular death, hospitalizations for heart failure, or urgent heart failure visits.

Participants in this study will be randomly assigned to receive either the combination of vicadrostat and empagliflozin or empagliflozin with placebo. The study will track outcomes such as cardiovascular events and measure heart failure symptoms using a questionnaire. This is a double-blind study, which means neither the participants nor the researchers will know which treatment each participant is receiving during the study.

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

    Initial Screening and Start of Trial

    After signing the consent form, you will undergo initial screening to confirm your eligibility. You need to have been diagnosed with chronic heart failure at least 3 months before joining the study, with a left ventricular ejection fraction (LVEF) less than 40% (which means your heart's pumping function is reduced).

    Your blood levels of a substance called NT-proBNP will be measured to confirm your heart failure status.

    You must be at least 18 years old to participate in this trial.

  2. Step 2

    Randomization and Medication Assignment

    You will be randomly assigned to one of two treatment groups:

    Group 1: Vicadrostat (BI 690517) plus empagliflozin

    Group 2: Placebo plus empagliflozin

    Both medications are provided as film-coated tablets that you will take by mouth.

    If you were already taking an SGLT2 inhibitor medication before the study, it will be replaced with the study medication.

  3. Step 3

    Treatment Period

    You will take the study medications for the duration of the trial while continuing your other heart failure medications.

    Your standard heart failure treatment should include (unless not suitable for you):

    • An ACE inhibitor, ARB, or ARNi (medications that help your heart function)

    • A beta-blocker (medication that reduces heart workload)

    • If appropriate, an SGLT2 inhibitor (empagliflozin will be provided as part of the study)

  4. Step 4

    Follow-up Visits and Assessments

    You will have regular follow-up visits throughout the study period (until approximately November 2025).

    At Week 32, your heart failure symptoms will be assessed using a questionnaire called Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS).

    Throughout the study, you will be monitored for any heart failure events, including:

    • Hospitalizations for heart failure (when you need to be admitted to hospital because of worsening heart failure)

    • Urgent heart failure visits (when you need immediate medical attention for heart failure but aren't admitted)

    • Cardiovascular death (death related to heart or blood vessel problems)

  5. Step 5

    Study Completion

    The trial is expected to run until January 2028, though your individual participation may end earlier.

    At the end of your participation, you will have a final assessment and return to your regular heart failure treatment as recommended by your doctor.

Who can join the trial?

11 criteria

  • Must be at least 18 years old (or the legal age of consent in your country if higher)
  • Must provide written informed consent before participating
  • Can be male or female. Women who can become pregnant must be willing to use highly effective birth control methods
  • Must have chronic heart failure diagnosed at least 3 months before the first study visit
  • Must be classified as having heart failure symptoms ranging from mild to severe (NYHA class II to IV) at the first visit
  • Must have a heart function measurement (LVEF) less than 40% as shown by heart imaging tests within the last 12 months
  • Must have elevated levels of a heart failure marker in the blood (NT-proBNP):
    • At least 600 pg/mL (or 400 pg/mL if hospitalized for heart failure in the past year) for people without atrial fibrillation
    • At least 1200 pg/mL for people with atrial fibrillation (a type of irregular heart rhythm)
    • Must be currently receiving standard heart failure treatment according to guidelines, which generally includes:
      • An ACE inhibitor, ARB, or ARNi (medications that help the heart work better)
      • A beta-blocker (medication that reduces heart workload)
      • If already taking an SGLT2 inhibitor (a diabetes medication that also helps heart failure), this will be replaced by the study medication

Who cannot join the trial?

11 criteria

  • Having heart failure with preserved ejection fraction (this means your heart can still pump out a normal amount of blood)
  • Currently taking a mineralocorticoid receptor antagonist (a type of medication often used to treat heart failure)
  • Having severe kidney disease with an estimated filtration rate below 20 mL/min/1.73m²
  • Having elevated potassium levels in your blood (above 5.0 mEq/L)
  • Having very low blood pressure when standing or sitting
  • Being pregnant or breastfeeding
  • Having a planned cardiac surgery or other major procedure during the study period
  • Having had a heart attack or stroke within the last 90 days
  • Having uncontrolled diabetes with very high blood sugar levels
  • Having a known allergy to any of the study medications
  • Participating in another clinical trial at the same time
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Investigated drugs

  • Vicadrostat (BI 690517)

    is an investigational medication being studied for the treatment of heart failure. It is taken orally and is being evaluated for its potential benefits in people with chronic heart failure who have a reduced heart pumping function.

  • Empagliflozin

    is a medication that belongs to a class of drugs called SGLT2 inhibitors. It is already approved for treating type 2 diabetes and heart failure. In this study, all participants will receive empagliflozin along with either vicadrostat or placebo.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active drug. In this study, some participants will receive a placebo instead of vicadrostat, while still receiving empagliflozin.

What is already known about the treatment

  • Vicadrostat (BI 690517)

    This is an oral medication being investigated for heart failure. It belongs to the class of mineralocorticoid receptor antagonists (MRAs) and works at the molecular level by blocking aldosterone receptors, which helps reduce fluid retention and prevent heart damage. Vicadrostat is currently in Phase III clinical trials for patients with chronic heart failure with reduced ejection fraction (HFrEF), particularly those who aren't already taking MRAs. This medication aims to improve outcomes such as reducing cardiovascular death and hospitalization when used in combination with empagliflozin.

  • Empagliflozin

    This is an oral medication that belongs to the class of SGLT2 inhibitors, which work by preventing glucose reabsorption in the kidneys, leading to increased glucose excretion in urine. At the molecular level, empagliflozin blocks sodium-glucose co-transporter 2 proteins, which has beneficial effects beyond glucose control, including cardiovascular and renal protection. It is FDA-approved for type 2 diabetes and has received approval for treating heart failure with reduced ejection fraction, as it has been shown to reduce the risk of cardiovascular death and hospitalization for heart failure.

Investigated diseases

Heart failure - A condition where the heart cannot pump enough blood to meet the body's needs. It develops when the heart muscle becomes too weak or stiff to function properly. Heart failure can cause fluid to build up in the lungs and other tissues, leading to symptoms like shortness of breath, fatigue, and swelling in the legs and ankles. The disease often progresses gradually, with symptoms worsening over time as the heart becomes increasingly unable to maintain adequate circulation. Heart failure with reduced ejection fraction (HFrEF) specifically refers to cases where the left ventricle's pumping capacity (ejection fraction) is below 40%.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519525-38-00Protocol code1378-0018Estimated enrolment4 132 patientsSponsorBoehringer Ingelheim International GmbH

sourced from the EU Clinical Trials Register and site verification

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