Evaluating the Effect of Vicadrostat and Empagliflozin Combination Compared to Empagliflozin Alone in Patients with Heart Failure and Reduced Left Ventricular Function
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.
1Initial 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.
2Randomization 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.
3Treatment 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)
4Follow-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)
5Study 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 Study?
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 Study?
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
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.
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%.
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