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Study on BI 690517 and Empagliflozin for Patients with Heart Failure and Preserved Ejection Fraction

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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 new treatment for people with heart failure. Heart failure is a condition where the heart doesn't pump blood as well as it should. The study will test a combination of two medications: BI 690517 and empagliflozin. Empagliflozin is a medication already used to treat heart failure, while BI 690517 is a new drug being tested. Some participants will receive a placebo, which looks like the real medication but does not contain any active ingredients.

The purpose of the study is to see if the combination of BI 690517 and empagliflozin is more effective than empagliflozin alone in helping people with heart failure. Participants in the study will be randomly assigned to receive either the combination of BI 690517 and empagliflozin or a placebo and empagliflozin. The study will last for a period of 42 days, during which participants will take the medications orally, meaning they will swallow them in the form of tablets.

Throughout the study, researchers will monitor participants to see how the treatment affects their heart failure symptoms and overall health. The main focus will be on the time it takes for a participant to experience a serious heart-related event, such as a heart-related death or hospitalization due to heart failure. The study aims to provide valuable information on whether the new combination treatment can improve outcomes for people living with heart failure.

The research process

The trial runs in 6 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, participants will be required to provide written informed consent. This ensures understanding and agreement to participate in the trial.

    Eligibility will be confirmed based on criteria such as age, diagnosis of heart failure, and other health conditions.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to confirm heart failure diagnosis and measure left ventricular ejection fraction (LVEF).

    Additional tests may include imaging to check for structural heart abnormalities and blood tests to measure NT-proBNP levels.

  3. Step 3

    Randomization and treatment

    Participants will be randomly assigned to receive either the combination of BI 690517 and empagliflozin or a placebo with empagliflozin.

    The medications will be administered orally in the form of film-coated tablets.

  4. Step 4

    Treatment duration

    The treatment will continue until the estimated end date of the trial, which is November 5, 2027.

    Participants will be monitored regularly to assess the effectiveness and safety of the treatment.

  5. Step 5

    Follow-up assessments

    Regular follow-up assessments will be conducted to monitor heart health, including checking for any heart failure events or changes in symptoms.

    Participants will be evaluated for any side effects or adverse reactions to the treatment.

  6. Step 6

    Completion of the trial

    Upon completion of the trial, participants will undergo a final assessment to evaluate the overall impact of the treatment on heart failure symptoms and quality of life.

    The results will contribute to understanding the effectiveness of the combination treatment for heart failure.

Who can join the trial?

11 criteria

  • Must be at least 18 years old and meet the legal age of consent in your country if it's higher than 18.
  • Need to sign a written consent form before joining the trial.
  • Both men and women can participate. Women who can have children must use very effective birth control methods.
  • Must have been diagnosed with **chronic heart failure** at least 3 months before the first visit and be in NYHA class II-IV. NYHA class refers to how severe your heart failure is, with class II being mild and class IV being severe. Your **LVEF** (left ventricular ejection fraction) should be 40% or higher. LVEF is a measure of how well your heart pumps blood.
  • Must have a **structural heart abnormality**, which means there is a change in the heart's structure, confirmed by imaging tests like an echocardiogram.
  • Must have elevated **NT-proBNP** levels. NT-proBNP is a substance in the blood that increases when heart failure worsens. The required level depends on your **BMI** (body mass index) and whether you have **Afib** (atrial fibrillation) or **Aflutter** (atrial flutter), which are types of irregular heartbeats.
  • Must meet at least one of the following:
    • Currently taking diuretics, which are medications that help remove excess fluid from the body, and have been on a stable dose for at least a week.
    • Have been hospitalized for heart failure in the last 6 months.
    • Have elevated NT-proBNP levels as specified for your condition.
    • Must be receiving the best possible standard of care for heart failure according to local or international guidelines, as judged by the trial doctor.
    • There are additional criteria that apply.

Who cannot join the trial?

8 criteria

  • Patients with a history of severe allergic reactions to the study medications cannot participate.
  • Individuals with uncontrolled high blood pressure are excluded.
  • Patients with severe kidney disease are not eligible.
  • Those with liver disease that affects liver function cannot join the study.
  • Pregnant or breastfeeding women are not allowed to participate.
  • Patients with a history of drug or alcohol abuse in the past year are excluded.
  • Individuals with any other serious medical condition that might interfere with the study are not eligible.
  • Participants who are currently involved in another clinical trial are not allowed to join.
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Investigated drugs

  • BI 690517

    is an investigational medication being studied for its potential benefits in treating heart failure. It is being tested in combination with another medication to see if it can help improve heart function and reduce the risk of heart-related complications.

  • Empagliflozin

    is a medication commonly used to manage blood sugar levels in people with diabetes. In this trial, it is being used to see if it can also help people with heart failure by improving heart function and reducing the risk of heart-related events.

What is already known about the treatment

  • BI 690517

    This medication is administered orally and is currently being studied in clinical trials for its potential benefits in treating heart failure. It is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication for BI 690517 is heart failure, specifically in patients with a left ventricular ejection fraction of 40% or higher. The mechanism of action at the molecular level involves modulating pathways that may improve heart function and reduce symptoms of heart failure. It is classified pharmacologically as an investigational drug.

  • Empagliflozin

    This medication is taken orally and is well-established in medical literature, primarily used for managing type 2 diabetes and heart failure. It is currently being evaluated in combination with BI 690517 for its effectiveness in treating heart failure with preserved ejection fraction. Empagliflozin works by inhibiting the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, which helps lower blood sugar levels and may also have beneficial effects on heart function. It is classified as an SGLT2 inhibitor.

Investigated diseases

Heart Failure – Heart failure is a condition where the heart is unable to pump blood effectively to meet the body's needs. It can result from various underlying issues, such as coronary artery disease or high blood pressure, which weaken or stiffen the heart. As the condition progresses, individuals may experience symptoms like shortness of breath, fatigue, and swelling in the legs and abdomen. The heart's reduced ability to pump blood can lead to fluid buildup in the lungs and other parts of the body. Over time, heart failure can cause the heart to enlarge and work harder, further exacerbating the condition. Management focuses on lifestyle changes and medications to improve heart function and alleviate symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509706-30-00Protocol code1378-0020Estimated enrolment6 712 patientsSponsorBoehringer Ingelheim International GmbH

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