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Comparing Carvedilol and Metoprolol Succinate for Treating Heart Failure with Reduced Ejection Fraction in Patients at Heart Failure Clinics

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What is this trial about?

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

This clinical trial, known as CROWD-COMPARE, is focused on studying Heart Failure, a condition where the heart is unable to pump blood effectively. The trial aims to compare two medications, Carvedilol and Metoprolol succinate, which are both used to treat heart failure with reduced ejection fraction. Reduced ejection fraction means that the heart's left ventricle is not pumping as well as it should. These medications belong to a class of drugs called beta-blockers, which help to slow down the heart rate and reduce blood pressure, making it easier for the heart to pump blood.

The purpose of this study is to determine which of these two medications is more effective in reducing the risk of death from any cause or the first hospitalization due to worsening heart failure. Participants in the study will be patients who are already being treated for heart failure and have been prescribed either Carvedilol or Metoprolol succinate. The study will follow these patients over a period of time to observe the outcomes of their treatment.

Throughout the study, researchers will monitor the participants to see if there is a difference in the effectiveness of the two medications. The main focus will be on whether the patients experience any hospitalizations due to worsening heart failure or any other cause of death. This information will help doctors understand which medication might be better for treating heart failure with reduced ejection fraction. The study is expected to continue until 2029, providing valuable insights into the management of heart failure.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be registered as a participant in the study called CROWD-COMPARE. This study aims to compare the effectiveness of two medications, Carvedilol and Metoprolol succinate, in treating heart failure with reduced ejection fraction.
Step 2
Medication assignment
You will be assigned to take either Carvedilol or Metoprolol succinate. These medications are taken orally in the form of tablets. Carvedilol is provided as a 25 mg film-coated tablet, while Metoprolol succinate is provided as a 190 mg prolonged-release tablet.
Step 3
Medication administration
You will take the assigned medication as directed by the study team. The dosage and frequency will be specified by your healthcare provider based on your individual needs and the study protocol.
Step 4
Regular follow-up
Throughout the trial, you will have regular follow-up appointments at the heart failure clinic. These appointments are important for monitoring your health and the effects of the medication.
Step 5
Monitoring and reporting
During the trial, you will be monitored for any changes in your condition. It is important to report any side effects or new symptoms to the study team promptly.
Step 6
Completion of the trial
The trial is expected to continue until October 31, 2029. Upon completion, the study team will analyze the data to determine the effectiveness of the medications in reducing mortality and hospitalizations due to heart failure.

Who can join the trial?

5 criteria

Patients must have heart failure with reduced ejection fraction. This means the heart is not pumping as well as it should.
Patients should be registered in the Danish Heart Failure Registry.
Patients must have filled at least one prescription for either Carvedilol or Metoprolol succinate. These are medications used to treat heart failure.
Both men and women can participate.
Participants should not be part of a vulnerable population. This means they should not be in a group that needs special protection in research.

Who cannot join the trial?

4 criteria

Patients who do not have **Heart Failure** cannot participate.
Patients who do not have an indication for treatment with **beta-blockers** due to heart failure with reduced ejection fraction cannot participate. Beta-blockers are medications that reduce blood pressure and heart rate.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.

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Verified sites

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Odense University Hospital
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Odense, Denmark

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Investigated drugs

Carvedilol
is a medication used to treat heart failure. It works by slowing down your heart rate and relaxing your blood vessels, which makes it easier for your heart to pump blood around your body. This can help reduce symptoms of heart failure and improve your ability to exercise.
Metoprolol succinate
is another medication used to manage heart failure. Like Carvedilol, it helps by slowing your heart rate and relaxing blood vessels. This action helps your heart work more efficiently and can reduce the risk of hospitalization due to worsening heart failure.

What is already known about the treatment

Carvedilol
Carvedilol is a medication taken orally, usually in the form of a tablet, and is used to treat heart failure. It is currently recognized in medical literature as a beta-blocker, which is a class of drugs that help manage heart conditions. The main therapeutic use of Carvedilol is to improve heart function in patients with heart failure, particularly those with reduced ejection fraction. At the molecular level, Carvedilol works by blocking certain receptors in the heart, which helps to slow down the heart rate and reduce blood pressure, making it easier for the heart to pump blood.
Metoprolol Succinate
Metoprolol Succinate is an oral medication, typically administered as an extended-release tablet, and is used to treat heart failure. It is well-documented in medical literature as a beta-blocker, a type of drug that helps control heart-related issues. The primary therapeutic indication for Metoprolol Succinate is to enhance heart function in patients with heart failure with reduced ejection fraction. On a molecular level, it works by blocking specific receptors in the heart, which helps to decrease heart rate and lower blood pressure, aiding the heart in pumping blood more effectively.

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 often begins with the heart's inability to fill with enough blood or pump with enough force. Over time, the heart's chambers may become stiff or thickened, leading to further decline in function. As the condition progresses, fluid may build up in the lungs, liver, and other parts of the body, causing symptoms like shortness of breath, fatigue, and swelling. The progression can vary, with periods of stability followed by episodes of worsening symptoms. Heart failure can affect one or both sides of the heart, and its severity can range from mild to severe.