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Study on Atorvastatin's Effect on Preventing Atrial Fibrillation in Patients Undergoing Surgical Aortic Valve Replacement

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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 a medication called atorvastatin on patients who are undergoing a specific type of heart surgery known as surgical aortic valve replacement. This surgery involves replacing a damaged heart valve with a new one. The study is particularly interested in a condition called post-operative atrial fibrillation (POAF), which is a common heart rhythm problem that can occur after this type of surgery.

The purpose of the study is to see if taking atorvastatin, a medication that helps lower cholesterol, can reduce the chances of developing POAF after surgery. Participants in the study will take atorvastatin starting at least 7 to 14 days before their surgery and continue taking it until 30 days after the surgery. The study will also look at what happens if patients who have been taking statins, like atorvastatin, stop taking them before the surgery. The effects will be monitored using a device called a Holter monitor, which records heart activity over time.

Throughout the study, researchers will observe the participants for any occurrences of POAF and other potential complications, such as infections or heart-related issues. The study aims to provide valuable insights into how atorvastatin might help manage heart rhythm problems after heart valve surgery and whether stopping statin use before surgery affects the risk of these issues. Participants will be monitored closely to ensure their safety and to gather important data on the effectiveness of the treatment.

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 study
Participation begins after providing informed consent and meeting the eligibility criteria. Eligibility includes undergoing elective solitary surgical aortic valve replacement (SAVR) with a bioprosthesis, being in sinus rhythm, and not taking any anti-arrhythmic medication other than beta-blockers. Participants must be over 60 years old.
Step 2
Pre-surgery medication
If not previously using statins, start taking atorvastatin at a dose of 80 mg orally once daily. This should begin at least 7 to 14 days before the surgery.
Step 3
Surgery
Undergo the scheduled surgical aortic valve replacement with a bioprosthesis.
Step 4
Post-surgery medication
Continue taking atorvastatin 80 mg orally once daily until the 30th day after surgery.
Step 5
Monitoring and evaluation
The incidence of post-operative atrial fibrillation (POAF) is evaluated using Holter monitoring. This monitoring helps assess heart rhythm and detect any irregularities.
Step 6
Follow-up
Participants are monitored for any complications, including infections, myocardial injury, stroke, and other conditions. The follow-up period includes assessments within 30 days and up to 1 year after surgery.

Who can join the trial?

6 criteria

Patients must be undergoing an elective solitary **surgical aortic valve replacement (SAVR)** with a **bioprosthesis**. This means they are having a planned surgery to replace the aortic valve with a valve made from animal tissue.
Patients should be in **sinus rhythm**, which is a normal heart rhythm, and not taking any **anti-arrhythmic medication** except for **beta-adrenergic blocking agents**. These are medications that help manage heart rhythm and blood pressure.
For Trial 1, patients should not have used **statins** in the last 3 months and at least 7 days before the surgery. Statins are medications used to lower cholesterol.
For Trial 2, patients should have been treated with statins in the past 3 months and for at least 7 days.
Patients must be over 60 years old.
Patients must be willing to participate and provide **informed consent**. This means they agree to join the study after understanding what it involves.

Who cannot join the trial?

8 criteria

Patients who are not undergoing surgical aortic valve replacement.
Patients who have already been taking statins in the last 3 months for at least 7 days.
Patients who are not statin-naïve, meaning they have previously used statins.
Patients who are not able to start taking Atorvastatin at least 7 to 14 days before surgery.
Patients who cannot continue taking Atorvastatin until the 30th day after surgery.
Patients who are not undergoing elective solitary SAVR with a bioprosthesis. Elective means the surgery is planned in advance, and solitary means only one procedure is being done.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Odense University Hospital
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Odense, Denmark

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Investigated drugs

Atorvastatin
is a medication used in this trial to see if it can help reduce the occurrence of irregular heartbeats, known as post-operative atrial fibrillation (POAF), after heart valve surgery. Patients who have not previously taken statins will start taking Atorvastatin before their surgery and continue taking it for a period after the surgery to see if it helps prevent these irregular heartbeats.
Statin Discontinuation
is another aspect of the trial, where researchers are looking at what happens when patients who have been taking statins stop using them before their heart valve surgery. The study aims to find out if stopping statins increases the risk of irregular heartbeats or other complications after the surgery.

Atorvastatin

What is already known about the treatment

Atorvastatin – Atorvastatin is administered orally in the form of tablets. It is currently being studied in clinical trials to assess its effects on post-operative atrial fibrillation in patients undergoing surgical aortic valve replacement. The main therapeutic indication for atorvastatin is to lower cholesterol levels and reduce the risk of heart disease. At the molecular level, it works by inhibiting the enzyme HMG-CoA reductase, which plays a crucial role in the production of cholesterol in the liver. Atorvastatin is classified as a statin, a type of lipid-lowering medication.

Investigated diseases

Atrial Fibrillation
Atrial fibrillation is a common heart rhythm disorder where the heart's upper chambers (atria) beat irregularly and often rapidly. This irregular rhythm can lead to poor blood flow and may cause symptoms like palpitations, fatigue, and shortness of breath. Over time, atrial fibrillation can lead to complications such as blood clots, which may increase the risk of stroke. The condition can be persistent or occur in episodes, and its severity can vary among individuals. It often requires monitoring and management to prevent further complications.
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. Symptoms can include chest pain, shortness of breath, and discomfort in the upper body. The severity and progression of a myocardial infarction can vary, and it requires immediate medical attention to restore blood flow and minimize heart damage.
Stroke
A stroke happens when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. This can cause brain cells to begin dying within minutes. Symptoms may include trouble speaking, paralysis or numbness of the face, arm, or leg, and problems with vision or balance. The effects of a stroke depend on the area of the brain affected and the length of time the brain is without blood flow. Early intervention is crucial to minimize brain damage and potential complications.
Acute Kidney Injury
Acute kidney injury is a sudden episode of kidney failure or kidney damage that happens within a few hours or days. It causes a build-up of waste products in the blood and makes it hard for the kidneys to maintain the right balance of fluid in the body. Symptoms may include decreased urine output, swelling due to fluid retention, and fatigue. The condition can be caused by a variety of factors, including reduced blood flow to the kidneys, direct damage to the kidneys, or blockage of the urinary tract. It often requires prompt treatment to prevent further kidney damage.