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Study on the Effects of Dapagliflozin for Patients with Aortic Stenosis Undergoing 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 the medication dapagliflozin on patients with aortic stenosis, a condition where the heart's aortic valve narrows, affecting blood flow. The study aims to see how dapagliflozin, which is taken as a 10 mg film-coated tablet, can improve heart and kidney function after patients undergo a procedure called transcatheter aortic valve replacement (TAVR). This procedure is used to replace the narrowed aortic valve without open-heart surgery.

The purpose of the study is to evaluate whether dapagliflozin can help improve heart muscle function, reduce heart muscle thickening, and enhance kidney function. The study will also look at whether the medication can decrease the chances of heart failure getting worse and reduce the risk of death. Participants in the study will either receive dapagliflozin or a placebo, which is a substance with no active medication, to compare the effects.

Participants will be monitored over a period of time to assess changes in their heart and kidney health. The study will track various health indicators, such as heart muscle thickness and kidney function, to determine the effectiveness of dapagliflozin. The goal is to gather information that could lead to better treatment options for people with aortic stenosis who have undergone the TAVR procedure.

The research process

The trial runs in 4 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, the patient will have already signed an informed consent form. This indicates understanding and agreement to participate in the trial.
The patient must be scheduled for a transcatheter aortic valve replacement (TAVR) due to significant symptomatic aortic stenosis.
Step 2
Medication administration
The patient will receive either Forxiga 10 mg film-coated tablets or a placebo. The placebo consists of glucosemonohydrate encapsulated in a capsule.
The medication is administered orally. The specific dosage and frequency will be determined by the study protocol.
Step 3
Monitoring and follow-up
The patient's heart and kidney functions will be monitored throughout the study. This includes evaluating the effect of the medication on heart muscle function, heart tissue stiffness, heart size, and kidney function.
The study will assess changes in specific health markers over a 12-month period. These include heart muscle mass, heart function, and kidney filtration rate.
Step 4
Completion of the study
The study is expected to conclude by June 30, 2026. At the end of the study, the patient will undergo final assessments to evaluate the effects of the treatment.
The primary goal is to observe improvements in heart and kidney functions, as well as a reduction in heart failure symptoms and mortality.

Who can join the trial?

7 criteria

You must have signed an informed consent form, which means you agree to participate in the study after understanding all the details.
You should be scheduled for a procedure called Transcatheter Aortic Valve Replacement (TAVR) to treat a condition known as aortic stenosis, which is a narrowing of the heart's aortic valve.
Your age must be between 18 and 85 years old.
Your heart's pumping ability, known as Left Ventricular Ejection Fraction (LVEF), should be between 40% and 50%, or more than 50% with certain conditions like:
- LV GLS (a measure of heart muscle function) less than 15% as seen in an ultrasound of the heart.
- The thickness of the heart's walls should be 12mm or more, or the heart's mass index should be at least 108/131 g/m² for females/males, indicating mild thickening of the heart muscle.
- If your LVEF is more than 50%, your Nt-proBNP (a blood test that shows heart stress) should be more than 600 ng/l if you have a normal heart rhythm, or more than 900 ng/l if you have a condition called atrial fibrillation.
- Your kidney function, measured by a test called eGFR, should be more than 30 mL/min/1.73 m².

Who cannot join the trial?

5 criteria

Patients who have a condition called aortic stenosis, which is a narrowing of the heart's aortic valve.
Patients who have not been treated with a procedure called transcatheter aortic valve replacement (TAVR), which is a method to replace the aortic valve without open-heart surgery.
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 do not meet other specific health criteria required for the study.

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Aarhus University Hospital
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Aarhus, Denmark

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Investigated drugs

Dapagliflozin is a medication used in this study to evaluate its effects on heart and kidney function in patients who have undergone a procedure to replace a narrowed aortic valve. The study aims to see if Dapagliflozin can improve heart muscle function, reduce heart muscle thickening, and improve kidney function. It also looks at whether the medication can help prevent worsening heart failure and reduce the risk of death in these patients.

Dapagliflozin

What is already known about the treatment

Dapagliflozin – Dapagliflozin is administered orally in tablet form. It is currently being studied for its effects on heart and kidney function in patients with aortic stenosis who have undergone transcatheter aortic valve replacement (TAVR). The main therapeutic indication being explored is its potential to improve heart muscle function, reduce heart muscle thickening, and enhance kidney function. At the molecular level, Dapagliflozin works by inhibiting the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, which helps lower blood sugar levels and may have protective effects on the heart and kidneys. It is classified as an SGLT2 inhibitor.

Investigated diseases

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 and potentially weaken. As the condition progresses, individuals may experience symptoms such as chest pain, fatigue, and shortness of breath, especially during physical activity. The heart may struggle to pump blood efficiently, leading to potential complications if left unaddressed. The progression of aortic stenosis can vary, with some individuals experiencing a slow worsening of symptoms, while others may have a more rapid decline. Regular monitoring and evaluation by healthcare professionals are essential to manage the condition effectively.