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Study on Optimizing Treatment for Chronic Heart Failure with Reduced Ejection Fraction Using Nebivolol and a Drug Combination

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying the treatment of chronic heart failure with reduced ejection fraction, a condition where the heart is unable to pump blood effectively. The study will involve several medications, including nebivolol, carvedilol, bisoprolol fumarate, spironolactone, sacubitril valsartan, and metoprolol succinate. These medications are commonly used to manage heart failure and are taken orally in tablet form.

The purpose of the study is to explore how the levels of these drugs in the blood relate to the health status of patients with heart failure. Participants will receive one or more of these medications, and their blood levels will be monitored over a period of up to 24 months. The study aims to determine if the concentration of these drugs in the blood is more important than the dosage for improving the condition of heart failure patients.

Throughout the study, researchers will also look at various health indicators, such as the concentration of a specific protein in the blood called NT-proBNP, the results of a 6-minute walk test, and responses to a quality of life questionnaire. Additionally, the study will assess the occurrence of any side effects and monitor adherence to the treatment plan. This research will help in understanding the best ways to use these medications to manage heart failure effectively.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
During the initial visit, eligibility for the study is confirmed. This includes verifying that the patient has chronic heart failure with reduced ejection fraction and is either already receiving or will start treatment with the specified medications.
Women of childbearing potential must provide a negative pregnancy test result and agree to use contraception throughout the study.
Step 2
Medication administration
The patient will take the following medications orally: nebivolol, carvedilol, bisoprolol fumarate, spironolactone, sacubitril valsartan, and metoprolol succinate.
The dosage and frequency of these medications will be determined by the healthcare provider based on individual needs and clinical indicators.
Step 3
Regular monitoring
Regular monitoring of serum drug concentrations will be conducted to assess their correlation with clinical indicators of heart failure.
Clinical indicators include NT-proBNP concentration, results from a 6-minute walk test, responses to a quality of life questionnaire, echocardiographic parameters, and hospitalization records.
Step 4
Follow-up visits
Follow-up visits will occur periodically to evaluate the patient's response to treatment and adjust medication as necessary.
During these visits, the healthcare provider will assess the patient's adherence to the treatment plan and monitor for any adverse effects.
Step 5
Study completion
The study is expected to conclude by April 30, 2026.
Upon completion, the data collected will be analyzed to determine the relationship between drug serum concentrations and clinical outcomes in patients with heart failure.

Who can join the trial?

5 criteria

Patients must have chronic heart failure with reduced ejection fraction (HFrEF), which means the heart is not pumping as well as it should.
Patients should already be receiving or have just started treatment with the specified medicines for heart failure.
Both male and female patients must be over 18 years old.
Patients need to sign an Informed Consent, which is a document that explains the study and confirms their willingness to participate.
Women who can have children must have a negative result on a blood test for pregnancy (called serum human chorionic gonadotropin or hCG) at the start of the study. They must also use a reliable method of birth control and take a home pregnancy test every 3 months during the study.

Who cannot join the trial?

3 criteria

Patients who do not have chronic heart failure with reduced ejection fraction. This means the heart is not pumping as well as it should.
Patients who are not within the specified age range. The study is looking for participants in certain age groups.
Patients who are part of a vulnerable population. This refers to groups of people who might need special protection or care.

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Verified sites

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University Hospital Ostrava
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Ostrava, Czechia

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Investigated drugs

Enalapril
is a medication used to treat high blood pressure and heart failure. It helps to relax blood vessels, making it easier for the heart to pump blood.
Metoprolol
is a beta-blocker that is used to treat high blood pressure and heart failure. It works by slowing down the heart rate and reducing the workload on the heart.
Spironolactone
is a diuretic that helps to remove excess fluid from the body. It is often used in heart failure to reduce swelling and improve breathing.
Furosemide
is another diuretic that helps to eliminate extra fluid from the body. It is commonly used to treat swelling and fluid retention in heart failure patients.
Digoxin
is a medication that helps to strengthen the heart muscle and improve its efficiency. It is used in heart failure to help the heart pump more effectively.
Ivabradine
is a medication that helps to slow the heart rate. It is used in heart failure to reduce the heart's workload and improve symptoms.

What is already known about the treatment

Carvedilol – Carvedilol is typically administered orally in tablet form. It is widely recognized in medical literature as a beta-blocker used to manage chronic heart failure with reduced ejection fraction. The medication works by blocking beta-adrenergic receptors, which helps to decrease heart rate and blood pressure, ultimately reducing the heart's workload. It is classified pharmacologically as a non-selective beta-blocker with alpha-blocking activity.

Investigated diseases

Chronic Heart Failure with Reduced Ejection Fraction – This condition occurs when the heart muscle is unable to pump blood efficiently, leading to a reduced ejection fraction, which is a measure of how much blood the left ventricle pumps out with each contraction. Over time, the heart becomes weaker, and symptoms such as shortness of breath, fatigue, and fluid retention may develop. The progression of the disease can lead to worsening heart function and increased difficulty in performing daily activities. As the heart struggles to meet the body's demands, patients may experience episodes of worsening symptoms, known as exacerbations. These exacerbations can result in hospitalizations and require adjustments in management to stabilize the condition.