Not recruiting

Study on the Effects of Carvedilol, Metoprolol Tartrate, and Bisoprolol Fumarate in Patients After a Heart Attack with Normal Heart Pumping Function

Verified siteRegistered drugNo placebo

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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 effects of beta-blocker medications in patients who have experienced a myocardial infarction, commonly known as a heart attack, but do not have a reduced ejection fraction. Ejection fraction is a measurement of how well the heart is pumping blood. The medications being studied include Carvedilol, Metoprolol, Bisoprolol, and Nebivolol. These medications are taken orally in the form of tablets. The purpose of the study is to understand how these medications might help in preventing further heart-related issues such as another heart attack, stroke, or heart failure.

Participants in the study will be randomly assigned to receive either one of the beta-blocker medications or a placebo. The study will last for a period of up to 77 days, during which participants will take the medication daily. Throughout the study, participants will be monitored for any changes in their health, particularly focusing on heart-related events. The study aims to gather information on whether these medications can reduce the risk of serious heart problems and improve overall health outcomes for patients who have had a heart attack.

In addition to the main focus on heart health, the study will also look at other aspects such as the quality of life, any side effects from the medications, and how these medications might affect other conditions like Chronic Obstructive Pulmonary Disease or diabetes. The findings from this study could provide valuable insights into the benefits and risks of using beta-blockers in patients with a history of heart attack but without reduced heart function.

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 assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, heart function, and recent heart attack history.
Eligibility criteria include being 18 years or older, having a heart function greater than 40%, and a recent heart attack diagnosis.
Step 2
Medication allocation
Participants are assigned to receive one of the following medications: carvedilol, metoprolol tartrate, bisoprolol fumarate, or nebivolol hydrochloride.
These medications are administered orally in tablet form. Dosages vary and may include 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg for carvedilol; 2.5 mg, 5 mg, or 10 mg for bisoprolol; and 5 mg for nebivolol.
Step 3
Treatment phase
Participants take the assigned medication daily. The duration of this phase extends until the estimated end date of the trial in April 2025.
Regular monitoring is conducted to assess the effects of the medication on heart health and overall well-being.
Step 4
Follow-up assessments
Throughout the trial, follow-up assessments are performed to monitor health outcomes such as heart function, occurrence of any heart-related events, and overall health status.
These assessments help evaluate the effectiveness and safety of the medication.
Step 5
Completion of trial
At the end of the trial, a final assessment is conducted to gather comprehensive data on the participant's health and the impact of the medication.
The trial aims to determine the benefits and risks associated with beta-blocker therapy after a heart attack.

Who can join the trial?

6 criteria

Must be 18 years or older.
Must have a left ventricular ejection fraction (LVEF) greater than 40%. This is a measure of how well the heart is pumping blood.
Must have had a myocardial infarction (MI), which is another term for a heart attack. The diagnosis must meet specific criteria, including a rise or fall in heart-related markers in the blood, along with at least one of the following:
- Symptoms of ischemia, which means reduced blood flow to the heart.
- New or presumed new significant changes in the heart's electrical activity, seen on an ECG (a test that records the heart's electrical signals).
- Development of pathological Q waves in the ECG, which are specific changes in the heart's electrical pattern.
- Imaging evidence showing new loss of heart muscle or new abnormal movement of the heart wall.

Who cannot join the trial?

4 criteria

Patients who have had a myocardial infarction, which is commonly known as a heart attack.
Patients who are not within the specified age range for the study.
Patients who belong to a specific clinical trial group that is not included in this study.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Aalborg University Hospital
Verified
Aalborg, Denmark
Region Midtjylland
Responsive
Aarhus, Denmark
Roskilde University
Responsive
Roskilde, Denmark

Trial locations

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Investigated drugs

Beta Blocker is a type of medication used in this trial to help manage heart conditions. It works by slowing down the heart rate and reducing the heart's workload, which can help prevent further heart problems after a heart attack. This medication is being tested to see if it can reduce the risk of recurrent heart attacks, strokes, and other serious heart-related issues in patients who have had a heart attack but do not have a reduced ejection fraction.

What is already known about the treatment

Beta Blocker – This medication is typically administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating patients who have experienced a myocardial infarction, commonly known as a heart attack, without reduced ejection fraction. The main therapeutic use of beta blockers is to manage heart conditions by reducing heart rate, blood pressure, and strain on the heart. At the molecular level, beta blockers work by blocking the effects of adrenaline on the heart's beta receptors, which helps to decrease heart rate and blood pressure. They are classified pharmacologically as beta-adrenergic blocking agents.

Investigated diseases

Myocardial Infarction – Myocardial infarction, commonly known as a heart attack, occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. This blockage is often due to a buildup of fat, cholesterol, and other substances, which form a plaque in the coronary arteries. The progression of the disease can lead to severe chest pain, shortness of breath, and other symptoms. Over time, the affected heart muscle may weaken, leading to complications such as heart failure or arrhythmias. The severity and progression can vary depending on the extent of the blockage and the area of the heart affected.