Study on Empagliflozin for Patients with Aortic Stenosis After Aortic Valve Replacement

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Jardiance (empagliflozin) in patients who have undergone an aortic valve replacement (AVR). The study is particularly interested in patients with a condition known as aortic stenosis, which is a narrowing of the heart’s aortic valve that can lead to serious heart problems. The purpose of the study is to determine if Jardiance can help reduce the size of the heart’s left ventricle, which is the main pumping chamber, and improve symptoms in patients after they have had their aortic valve replaced.

Participants in the study will be randomly assigned to receive either Jardiance or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug. The study will monitor changes in the heart’s left ventricle over a period of 12 months after the aortic valve replacement. This will be done using imaging techniques like computed tomography (CT) and echocardiography, which are methods to take detailed pictures of the heart. The study will also look at other factors such as heart function and levels of a heart-related protein called NT-proBNP.

The trial aims to provide valuable information on whether Jardiance can offer additional benefits to patients recovering from aortic valve replacement surgery. By understanding these effects, the study hopes to improve treatment options and outcomes for individuals with aortic stenosis who undergo this type of heart surgery.

1 joining the study

Participation begins after undergoing aortic valve replacement (AVR) surgery, either surgical or transcatheter, within the last 14 days.

Eligibility requires severe symptomatic aortic stenosis.

2 medication administration

Receive Jardiance 10 mg film-coated tablets, containing the active substance empagliflozin.

Take the medication orally as prescribed by the study protocol.

3 monitoring and assessments

Undergo regular assessments to monitor changes in heart function and structure.

Primary focus is on the change in left ventricular mass, measured by CT scans, from before AVR to 12 months after.

Secondary assessments include left ventricular end-systolic volume, global longitudinal strain, NT-proBNP levels, and tracking of any unplanned hospital readmissions or mortality.

4 study duration

The study is designed to last until October 2026.

Regular follow-ups and assessments will occur throughout the study period to evaluate the effects of the medication.

Who Can Join the Study?

Must have severe symptomatic aortic stenosis. This means the heart valve that controls blood flow from the heart to the body is very narrowed and causing symptoms.
Must have had surgical or transcatheter aortic valve replacement (AVR) within the last 14 days. This is a procedure to replace the narrowed heart valve.
Must be an adult, as the study includes age ranges typically for adults.
Both male and female participants are eligible.
Participants should not be from a vulnerable population, meaning they should be able to give informed consent and participate fully in the study.

Who Cannot Join the Study?

Patients with any condition other than aortic stenosis that might interfere with the study.
Patients who have not undergone AVR (aortic valve replacement), which is a surgery to replace a narrowed heart valve.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, meaning they might need special protection or care.
Patients who are not able to follow the study procedures or instructions.
Patients who are currently participating in another clinical trial.
Patients with any medical condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	02.10.2023

Trial locations

Investigated drugs:

Empagliflozin

Empagliflozin is a medication used in this trial. It belongs to a class of drugs known as SGLT2 inhibitors. These medications help lower blood sugar levels in people with type 2 diabetes by helping the kidneys remove sugar from the body through urine. In this trial, empagliflozin is being tested to see if it can reduce the size of the heart’s left ventricle and improve symptoms in patients who have undergone aortic valve replacement surgery.

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. This narrowing can cause the heart to work harder to pump blood, leading to symptoms such as chest pain, fatigue, and shortness of breath. Over time, the increased workload on the heart can cause the heart muscle to thicken, a condition known as left ventricular hypertrophy. As the disease progresses, it may lead to heart failure if the heart cannot pump enough blood to meet the body’s needs. The severity of symptoms can vary, and some individuals may remain asymptomatic for years. Regular monitoring and medical evaluation are important to assess the progression of the disease.

Trial ID:

2023-504731-40-01

Protocol code:

2023-504731-40-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Empagliflozin for Patients with Aortic Stenosis After Aortic Valve Replacement

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?