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Study on Teprenone for Preventing Atrial Fibrillation After Heart Surgery in Patients

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 postoperative atrial fibrillation, a common heart rhythm problem that can occur after heart surgery. The study aims to find out if a medication called Teprenone can help prevent this condition. Teprenone is taken orally in the form of granules. Another substance involved in the study is Medium-chain triglycerides (Miglyol 812N), which is used in combination with the main medication.

The purpose of the study is to see if Teprenone can reduce the chances of developing atrial fibrillation after undergoing heart surgery, such as surgery for mitral or aortic valve issues or coronary artery disease. Participants in the study will receive either the medication or a placebo, and their heart rhythm will be monitored to check for any signs of atrial fibrillation. The study will also look at how the medication affects certain proteins in the body that help protect cells from stress.

The study will take place over a period of time, with participants being monitored closely after their surgery. The researchers will use various methods to assess the effects of the medication, including checking heart rhythms and analyzing blood and tissue samples. The goal is to gather information that could lead to better prevention strategies for atrial fibrillation after heart surgery.

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
Joining the study
Upon joining the study, eligibility is confirmed based on age (18 to 80 years) and the need for cardiothoracic surgery due to specific heart conditions such as mitral valve stenosis or regurgitation, aortic valve stenosis or regurgitation, or coronary artery disease.
Step 2
Medication administration
The medication teprenone is administered orally. The dosage and frequency are determined by the study protocol, which aims to prevent postoperative atrial fibrillation.
Step 3
Surgery and monitoring
After the cardiothoracic surgery, the incidence of postoperative atrial fibrillation is assessed using Holter monitoring. This involves continuous recording of heart activity to detect any irregularities.
Step 4
Secondary assessments
Secondary assessments include the activation of heat shock proteins (HSPs) through biochemical analysis and microscopic imaging. These assessments are conducted on blood, atrial tissue, and epicardial adipose tissue.
Step 5
Trial duration
The trial is expected to conclude by August 1, 2025. Recruitment for the study is anticipated to start on August 1, 2024.

Who can join the trial?

9 criteria

Must be between 18 and 80 years old.
Scheduled for **cardiothoracic surgery**, which is surgery on the heart or chest area.
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The surgery must be for one or more of the following conditions:
- **Mitral valve stenosis**, which is a narrowing of the heart's mitral valve.
- **Mitral valve regurgitation**, which is when the mitral valve doesn't close tightly, allowing blood to flow backward in the heart.
- **Aortic valve stenosis**, which is a narrowing of the heart's aortic valve.
- **Aortic valve regurgitation**, which is when the aortic valve doesn't close properly, causing blood to leak back into the heart.
- **Coronary artery disease**, which is a condition where the heart's blood vessels are narrowed or blocked.
- Both males and females can participate.
- Participants should not be from a vulnerable population, meaning they should not be in a situation that makes them more at risk or in need of special protection.

Who cannot join the trial?

4 criteria

Patients who have a history of **Postoperative Atrial Fibrillation**. This is a condition where the heart beats irregularly after surgery.
Patients who are not undergoing **cardiothoracic surgery**. This type of surgery involves operations on the heart and chest area.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

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Verified sites

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Verified
Amsterdam UMC
Amsterdam, The Netherlands

Trial locations

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Investigated drugs

GeranylGeranylAcetone is being studied to see if it can help prevent atrial fibrillation, which is a type of irregular heartbeat, in patients who have undergone heart or chest surgery. The goal is to reduce the chances of developing this condition after surgery, which can lead to complications.

Teprenone

What is already known about the treatment

GeranylGeranylAcetone – This medication is administered orally and is currently being studied in clinical trials for its potential to prevent postoperative atrial fibrillation, a common heart rhythm problem after heart surgery. It is not yet widely recognized in medical literature as a standard treatment. The main therapeutic indication is to reduce the occurrence of atrial fibrillation following cardiothoracic surgery. At the molecular level, GeranylGeranylAcetone is believed to work by stabilizing cell membranes and reducing inflammation, which may help in maintaining normal heart rhythm. It is classified pharmacologically as a cardioprotective agent.

Investigated diseases

Postoperative Atrial Fibrillation – This condition occurs when a person experiences an irregular and often rapid heart rate following surgery, particularly cardiothoracic procedures. It is characterized by disorganized electrical signals in the heart's upper chambers, leading to an irregular heartbeat. This can result in symptoms such as palpitations, shortness of breath, and fatigue. The condition typically arises within a few days after surgery and can vary in duration, sometimes resolving on its own. It is a common complication after heart surgery and can affect the recovery process. Monitoring and management are essential to address the symptoms and prevent further complications.