Study of beta blockers in patients with aortic stenosis undergoing transcatheter aortic valve replacement

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What is this study about?

This clinical trial focuses on patients with aortic stenosis, a condition where the heart’s aortic valve narrows, making it harder for blood to flow from the heart to the rest of the body. The study examines how beta-blockers (medications that reduce heart rate and blood pressure) affect patients who undergo transcatheter aortic valve replacement, a procedure to replace the narrowed aortic valve.

The study will evaluate different types of beta-blockers, including selective beta-blockers, beta-blockers combined with thiazides, and alpha-beta blockers. These medications will be given by mouth for up to 6 months. The purpose of the study is to understand how beta-blocker treatment impacts the outcomes of patients receiving valve replacement.

The research will track various health outcomes in patients for up to one year after their valve replacement procedure. This includes monitoring for heart-related events, such as heart failure, stroke, and heart rhythm problems. The study will also track how many patients need pacemakers or require hospital readmission during this time period.

1 Initial qualification

Your eligibility for the study will be verified based on your medical condition – severe symptomatic aortic stenosis that requires valve replacement.

You must be over 18 years old and scheduled for a planned transcatheter aortic valve replacement (TAVR) procedure.

You need to have been taking beta-blocker medications for at least 1 month before joining the study.

2 Treatment period

You will continue taking your prescribed beta-blocker medication by mouth.

The TAVR procedure will be performed to replace your aortic valve.

Your health status will be monitored during this period.

3 30-day follow-up

Your health will be evaluated after 30 days to check for any complications.

The medical team will monitor for events such as:

– Need for heart-related hospitalization

– Heart rhythm changes

– Stroke

– Need for a pacemaker

4 1-year follow-up

Your health status will be assessed again after 1 year.

The medical team will check for:

– Overall health status

– Heart-related issues

– Any complications from the procedure

– Heart rhythm status

– Need for additional treatments

5 Study completion

The study is expected to run until May 31, 2028.

Your participation will end after the 1-year follow-up assessment is complete.

Who Can Join the Study?

Patient must be 18 years or older
Patient must be able to understand and sign an informed consent form before participating in any study procedures
Patient must have severe symptomatic aortic stenosis (a condition where the heart valve becomes narrow and restricts blood flow)
Patient must be scheduled for elective TAVR (Transcatheter Aortic Valve Replacement – a minimally invasive procedure to replace the narrowed heart valve)
Patient must have a medical need for beta-blocker therapy (medications that reduce heart rate and blood pressure)
Patient must have been taking beta-blocker medications for at least 1 month before joining the study
Both men and women can participate in the study

Who Cannot Join the Study?

Having a known allergy or hypersensitivity to beta blockers (medications that reduce heart rate and blood pressure)
Current or recent heart rhythm problems known as heart block (when electrical signals in the heart are blocked)
Very low blood pressure (systolic blood pressure below 90 mmHg)
Severe heart failure with fluid in the lungs
Severe breathing problems or asthma
Already taking beta blocker medications
Having had a heart attack in the past 3 months
Severe kidney or liver disease
Pregnancy or breastfeeding
Unable to provide informed consent
Currently participating in another clinical trial
Having a condition that could interfere with following the study procedures
History of not following medical treatment plans

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Medical Center – University Of Freiburg	Bad Krozingen	Germany
Kerckhoff-Klinik GmbH	Bad Nauheim	Germany
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum	Bad Oeynhausen	Germany
Mmtpoig Ukoqonwmlq Ow Gdvk	Graz	Austria
Lizhdkgezrrgxphzj Sbpdnbaw	Salzburg	Austria

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	30.06.2025
Germany	Recruiting	30.06.2025

Trial locations

Beta blockers are medications that help control heart rate and blood pressure. They work by blocking the effects of certain stress hormones in the body. In this trial, they are being studied in patients undergoing transcatheter aortic valve replacement (TAVR), which is a minimally invasive heart procedure. Beta blockers may help manage the heart’s workload during and after the valve replacement procedure.

TAVR (Transcatheter Aortic Valve Replacement) is a minimally invasive procedure where a new heart valve is inserted through a small incision, typically in the leg, to replace a diseased aortic valve. While this is not a medication, it is the primary therapy being studied in combination with beta blockers in this trial.

Investigated diseases:

Aortic stenosis

Aortic stenosis – A condition where the aortic valve in the heart becomes narrowed and stiffened, usually due to age-related calcium buildup or congenital heart defects. This narrowing restricts blood flow from the heart to the rest of the body, forcing the heart to work harder to pump blood through the smaller opening. The condition typically develops gradually over many years, and as it progresses, the heart muscle thickens to compensate for the extra work. The restricted blood flow can cause the heart muscle to weaken over time.

Atrial fibrillation – An irregular and often rapid heart rhythm where the upper chambers of the heart beat chaotically and out of sync with the lower chambers. This irregular heartbeat disrupts normal blood flow through the heart chambers. The condition can be occasional, persistent, or permanent.

Heart failure – A chronic condition where the heart cannot pump blood effectively enough to meet the body’s needs. The heart muscle becomes either too weak to pump properly or too stiff to fill with blood. This causes blood and fluid to back up in the lungs and other parts of the body, leading to symptoms such as shortness of breath and swelling.

Ventricular tachycardia – A heart rhythm disorder caused by abnormal electrical signals in the lower chambers of the heart. The heart beats faster than normal, typically more than 100 beats per minute, which can affect the heart’s ability to pump blood effectively.

Bradycardia – A condition where the heart beats more slowly than normal, typically less than 60 beats per minute. The slow heart rate means that less oxygen-rich blood is being pumped throughout the body. This can occur due to problems with the heart’s natural pacemaker or the electrical pathways in the heart.

Trial ID:

2024-518731-11-00

Protocol code:

NCT06472934

NCT ID:

NCT06472934

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of beta blockers in patients with aortic stenosis undergoing transcatheter aortic valve replacement

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