Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, Spain
Recruiting
Study on the Effectiveness and Safety of Finerenone and Empagliflozin in Patients Hospitalized with Heart Failure
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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 treatment of Heart Failure, a condition where the heart is unable to pump blood effectively. The study will use a combination of two medications: Finerenone and an SGLT2 inhibitor. Finerenone, also known by its code name BAY 94-8862, is a medication that helps reduce the effects of certain hormones that can worsen heart failure. The SGLT2 inhibitor, which includes drugs like Jardiance (empagliflozin), helps the body remove excess sugar through urine and has shown benefits in heart failure management.
The purpose of this study is to determine if an early and intensive treatment strategy using both Finerenone and an SGLT2 inhibitor can improve outcomes for patients hospitalized with heart failure. Participants in the study will receive either the combination of these medications or the standard care typically provided for heart failure. The study will last for about six months, during which the health and progress of the participants will be closely monitored.
Throughout the study, researchers will assess various health outcomes, including the time it takes for any heart failure events to occur, changes in symptoms, and overall survival rates. The goal is to see if the combination therapy provides better results compared to the usual treatment methods. This study aims to offer new insights into managing heart failure more effectively and improving the quality of life for those affected by this condition.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
12 criteria
- Must be at least 18 years old or the legal age of majority in your country.
- Currently in the hospital or recently discharged (within the last 10 days) with a primary diagnosis of heart failure.
- Have signs and symptoms of heart failure at the time of hospital admission, such as:
- Persistent difficulty breathing at rest or with minimal activity, worse than usual, or new or worsening difficulty breathing when lying flat.
- Signs of fluid buildup, like congestion seen on a chest X-ray, crackling sounds in the lungs when listened to with a stethoscope, noticeable swelling due to heart failure, or elevated pressure in the neck veins.
- Have elevated levels of certain heart-related proteins in the blood, measured during the current hospital stay or within 72 hours before hospital admission. These proteins are called N-terminal pro B-type natriuretic peptide (NTproBNP) or B-type natriuretic peptide (BNP). The required levels depend on whether you have a heart rhythm condition called atrial fibrillation.
- Meet certain stabilization criteria if you are randomized during hospitalization, such as:
- A systolic blood pressure of at least 100 mmHg and no symptoms of low blood pressure in the 6 hours before randomization.
- No increase in the dose of intravenous diuretics (medications that help remove excess fluid) for 6 hours before randomization.
- No intravenous medications that widen blood vessels, like nitrates, within the last 6 hours before randomization.
- No intravenous medications that help the heart pump or mechanical support for circulation for 24 hours before randomization.
- Received at least one intravenous dose of a loop diuretic (such as furosemide, torsemide, or bumetanide) during the hospital stay.
- If you are a woman who can become pregnant, you must have a negative pregnancy test at screening and agree to use effective birth control during the study, following local regulations.
- Must provide written informed consent to participate in the study.
Who cannot join the trial?
6 criteria
- Patients who do not have a heart condition cannot participate. A heart condition refers to any problem with the heart's structure or function.
- Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
- Patients who are not hospitalized with heart failure cannot participate. Heart failure is when the heart does not pump blood as well as it should.
- Patients who are not part of the specified clinical trial group cannot participate. This group is defined by specific characteristics needed for the study.
- Patients who are not willing to follow the study's procedures and requirements cannot participate.
- Patients who are part of a vulnerable population, such as those unable to give informed consent, cannot participate.
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Verified sites
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Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
ResponsiveMadrid, SpainHospital Universitario Hermanos Trias y Pujol. Institut Catalá d'Oncología (ICO)
VerifiedBadalona, Spain
Trial locations
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Investigated drugs
Finerenone
is a medication used in this trial to help manage heart failure. It works by blocking certain receptors in the body that can contribute to heart and kidney problems. The goal is to improve heart function and reduce the risk of heart-related events.
SGLT2 Inhibitor
is another type of medication included in the trial. It helps the body remove excess sugar through urine, which can also have beneficial effects on heart health. This medication is used to support heart function and improve outcomes for patients with heart failure.
What is already known about the treatment
Finerenone
Finerenone is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating heart failure. The main therapeutic indication for finerenone is to manage heart conditions, specifically heart failure. At the molecular level, finerenone works by blocking mineralocorticoid receptors, which helps reduce inflammation and fibrosis in the heart and kidneys. It is classified as a non-steroidal mineralocorticoid receptor antagonist.
SGLT2 Inhibitor
SGLT2 inhibitors are taken orally, usually in tablet form. They are being evaluated in clinical trials for their potential benefits in heart failure management. These medications are primarily used to treat heart conditions, particularly heart failure. SGLT2 inhibitors work by blocking the sodium-glucose co-transporter 2 in the kidneys, which leads to increased glucose excretion and helps reduce blood pressure and fluid overload. They belong to the class of medications known as sodium-glucose co-transporter 2 inhibitors.
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 develop over time as the heart becomes weaker or stiffer. Symptoms often include shortness of breath, fatigue, and swelling in the legs and ankles. The condition can progress gradually, with symptoms worsening as the heart's ability to function declines. It may lead to frequent hospitalizations due to exacerbations. Management focuses on improving symptoms and quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508874-27-00Protocol code202303CPCEstimated enrolment1 500 patientsSponsorColorado Prevention Center
sourced from the EU Clinical Trials Register and site verification
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