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Study on the Effectiveness and Safety of Finerenone and Empagliflozin in Patients Hospitalized with Heart Failure

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What is this study about?

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.

1 joining the study

Upon joining the study, the patient provides written informed consent to participate in the trial.

Eligibility is confirmed based on criteria such as age, current hospitalization for heart failure, and specific heart failure symptoms and signs.

2 initial assessment

An initial assessment is conducted to ensure stabilization criteria are met, including blood pressure and medication requirements.

A pregnancy test is conducted for women of childbearing potential, and they must agree to use adequate contraception during the study.

3 medication administration

The patient receives a combination therapy of finerenone and an SGLT2 inhibitor. Finerenone is administered orally in the form of film-coated tablets.

The specific dosage and frequency of administration are determined by the study protocol and the patient’s condition.

4 monitoring and follow-up

The patient’s health is monitored throughout the study, focusing on heart failure events and overall health outcomes.

Regular assessments are conducted to evaluate the patient’s response to the treatment, including changes in symptoms and any side effects.

5 evaluation of outcomes

The primary outcome is assessed by measuring clinical benefits, including time to all-cause mortality and heart failure events.

Secondary outcomes include changes in heart failure symptoms and the occurrence of heart failure-related hospitalizations or urgent visits.

6 completion of the study

The study is estimated to end by January 31, 2026, with all data collected and analyzed to determine the efficacy and safety of the treatment.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain

Other Sites

Site Name City Country Status
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital Universitario Virgen De La Victoria Malaga Spain
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Hgeplned Utndcnxjuputy Hqxckjjr Tjtld y Pljsdu Izchmkhr Cgkoar dlgonmewghgctpczt (txwm Badalona Spain
Hmmqixcd Ulitwndvlddbr dg A Cagvyf A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
31.01.2025

Trial locations

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.

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 ID:
2023-508874-27-00
Protocol code:
202303CPC
Trial Phase:
Therapeutic confirmatory (Phase III)

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