This clinical trial is focused on studying a heart condition known as heart failure. Specifically, it looks at patients who have been hospitalized due to a sudden worsening of their heart failure symptoms. The study is investigating a treatment using a medication called finerenone, which is taken as a film-coated tablet. The purpose of the study is to determine if finerenone can reduce the number of heart failure events and deaths related to heart problems compared to a placebo.
Participants in the study will be those who have been recently hospitalized with heart failure and have a certain level of heart function, measured by something called the ejection fraction. This is a percentage that shows how well the heart is pumping blood. The study will involve taking the medication or placebo for a period of time, and researchers will monitor the participants for any heart-related events or changes in their condition.
The study aims to gather information on the effectiveness and safety of finerenone in managing heart failure symptoms and improving survival rates. By comparing the outcomes of those taking finerenone with those taking a placebo, researchers hope to better understand the potential benefits of this treatment for patients with heart failure.
1Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, recent hospitalization for heart failure, and certain medical test results.
Participants must be at least 18 years old and have been hospitalized or recently discharged with a primary diagnosis of heart failure.
2Initial assessment
An initial assessment is conducted to evaluate heart function and symptoms. This includes checking for signs of fluid overload and measuring heart function through imaging tests.
Blood tests are performed to measure specific markers related to heart failure.
3Stabilization criteria
Before starting the treatment, certain stabilization criteria must be met. This includes maintaining stable blood pressure and not requiring increased doses of certain medications for at least 6 hours prior to starting the trial medication.
4Medication administration
Participants receive the study medication, finerenone, in the form of a film-coated tablet taken orally.
The dosage and frequency of administration are determined by the study protocol and are monitored throughout the trial.
5Monitoring and follow-up
Regular follow-up visits are scheduled to monitor heart function, symptoms, and any side effects of the medication.
Participants are assessed for any heart failure events or cardiovascular issues during the study period.
6Study completion
The study is expected to conclude by April 2026. At the end of the study, a final assessment is conducted to evaluate the overall effects of the medication on heart failure events and cardiovascular health.
Who Can Join the Study?
Participant must be at least 18 years old at the time of signing the informed consent.
Currently hospitalized or recently discharged (within 10 days before screening) with the main diagnosis of heart failure.
Signs and symptoms of heart failure at the time of hospital admission, including:
Symptoms like 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, such as congestion seen on a chest X-ray, crackling sounds in the lungs when listening with a stethoscope, noticeable swelling, or elevated neck vein pressure.
Imaging evidence showing a mildly reduced or preserved ejection fraction (40% or higher) from the most recent assessment, preferably during the current hospitalization. If not available, a previous assessment within the last 12 months can be used if no major event affecting heart function occurred since then.
High levels of certain heart-related proteins in the blood, measured during the current hospitalization 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 differ for patients with or without a heart rhythm problem called atrial fibrillation.
Meeting the following stabilization criteria if randomized during hospitalization:
Systolic blood pressure of at least 100 mmHg with 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, including nitrates, within the last 6 hours before randomization.
No intravenous medications that help the heart pump or mechanical support for 24 hours before randomization.
Treatment during the current hospitalization with at least one intravenous dose of a loop diuretic, such as furosemide, torsemide, or bumetanide.
Women who can become pregnant must have a negative pregnancy test at screening and agree to use effective birth control methods as per local regulations for the study’s duration.
Who Cannot Join the Study?
Patients with a heart condition cannot participate. This refers to any disease or disorder affecting the heart.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
Patients who are not part of the specified clinical trial groups cannot participate. These groups are usually defined by the study based on certain characteristics.
Patients who are not male or female cannot participate, as the study includes both genders.
Patients who are considered part of a vulnerable population cannot participate. This term refers to groups of people who may be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
Finerenone is a medication being studied to see if it can help reduce heart failure events and cardiovascular deaths in patients who have been hospitalized due to acute decompensated heart failure. This trial is focused on patients with a specific type of heart failure where the heart’s left ventricle pumps out a normal amount of blood, but the heart still doesn’t work as well as it should. The goal is to find out if finerenone can improve outcomes for these patients.
Heart Failure with Mid-Range Ejection Fraction (HFmrEF) – This condition occurs when the heart’s left ventricle does not pump blood as efficiently as it should, with an ejection fraction between 41% and 49%. Patients may experience symptoms such as shortness of breath, fatigue, and fluid retention. The heart’s ability to pump blood is compromised, leading to a reduced supply of oxygen and nutrients to the body. Over time, this can result in the heart muscle becoming weaker or stiffer. The progression of the disease can lead to more frequent hospitalizations due to worsening symptoms. Management focuses on improving heart function and alleviating symptoms.
Heart Failure with Preserved Ejection Fraction (HFpEF) – This condition is characterized by the heart’s inability to relax and fill properly, despite a normal ejection fraction of 50% or higher. Patients often experience symptoms like breathlessness, fatigue, and swelling in the legs. The heart muscle may become stiff, leading to increased pressure in the heart and lungs. This can cause fluid to build up in the lungs and other parts of the body. The disease can progress with increasing difficulty in performing daily activities. Management aims to control symptoms and improve quality of life.
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