Study on the Effects of Losartan Potassium in Patients with Mild to Moderate Aortic Stenosis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Losartan Potassium on a heart condition known as aortic stenosis. Aortic stenosis is a condition where the heart’s aortic valve narrows, which can affect blood flow from the heart to the rest of the body. The study aims to understand how Losartan Potassium, which is a type of medication known as an angiotensin receptor blocker, can impact this condition. Participants in the study will either receive Losartan Potassium or a placebo, which is a tablet that looks like the medication but does not contain any active ingredients.

The purpose of the study is to investigate the effect of angiotensin receptor blockers on mild to moderate aortic stenosis. Over the course of 24 months, participants will take the medication or placebo and undergo regular check-ups. These check-ups will include tests like echocardiography, which uses sound waves to create images of the heart, and magnetic resonance imaging (MRI), which uses magnets and radio waves to take detailed pictures of the heart. These tests will help doctors see how the heart and its valves are functioning and if there are any changes in the heart’s structure or function.

Throughout the study, doctors will monitor the rate at which the aortic valve narrows and any changes in the heart’s size and shape. They will also look at how well the heart is pumping blood and measure certain markers in the blood that can indicate heart health. The study will help determine if Losartan Potassium can slow down the progression of aortic stenosis and improve heart function compared to the placebo.

1 enrollment

Upon joining the study, eligibility is confirmed based on specific criteria such as age, blood pressure, and heart function.

Informed consent is required to participate in the trial.

2 randomization

Participants are randomly assigned to receive either losartan potassium or a placebo.

Both medications are administered orally.

3 treatment phase

The treatment involves taking the assigned medication daily for a duration of 24 months.

The purpose is to assess the effect of the medication on aortic stenosis.

4 monitoring and assessments

Regular assessments are conducted to monitor the progression of aortic stenosis using echocardiography and computed tomography.

Additional evaluations include measuring heart structure and function through imaging techniques.

5 completion

After 24 months, the study concludes with a final assessment of the heart’s condition.

The results are compared between the losartan potassium and placebo groups to determine the medication’s impact.

Who Can Join the Study?

Patients must have mild to moderate aortic stenosis. This means the heart valve that controls blood flow from the heart to the body is narrowed, but not severely.
Patients should be between 20 and 85 years old.
The left ventricular ejection fraction must be at least 50%. This is a measure of how well the heart is pumping blood.
Systolic blood pressure should be at least 100 mmHg. This is the top number in a blood pressure reading, indicating the pressure in the arteries when the heart beats.
Patients must provide signed informed consent, meaning they agree to participate in the study after being informed about it.

Who Cannot Join the Study?

Patients with severe aortic stenosis cannot participate. Aortic stenosis is a condition where the heart’s aortic valve becomes narrowed, affecting blood flow.
Patients who are not within the age range specified for the study cannot participate. The study is for certain age groups only.
Patients who are part of a vulnerable population, such as those who may not be able to give informed consent, cannot participate.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients with other medical conditions that might interfere with the study or pose a risk to their health cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Odense University Hospital	Odense	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	27.08.2020

Trial locations

Investigated drugs:

Angiotensin Receptor Blocker (ARB) – This medication is used to relax blood vessels, which helps to lower blood pressure and improve blood flow. In this trial, the ARB is being studied to see how it affects the condition of aortic stenosis, which is a narrowing of the heart’s aortic valve. The goal is to determine if the ARB can help manage or improve the symptoms of mild to moderate aortic stenosis.

Investigated diseases:

Aortic stenosis

Aortic stenosis – Aortic stenosis is a condition where the aortic valve in the heart becomes narrowed, restricting blood flow from the heart to the rest of the body. Over time, this narrowing can lead to increased pressure within the heart, causing the heart muscle to thicken. As the condition progresses, it may result in symptoms such as chest pain, fatigue, and shortness of breath, especially during physical activity. The heart may also struggle to pump blood efficiently, leading to potential complications. The progression of aortic stenosis can vary, with some individuals experiencing a slow worsening of symptoms. Regular monitoring is essential to assess the severity and impact on heart function.

Trial ID:

2024-518389-28-00

Protocol code:

ARBAS041218

NCT ID:

NCT04913870

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Losartan Potassium in Patients with Mild to Moderate Aortic Stenosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?