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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

13 criteria

  • 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
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Investigated drugs

  • 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.

What is already known about the treatment

Beta blockers - A class of medications commonly used in cardiovascular medicine, administered orally or intravenously, that work by blocking the effects of adrenaline and similar hormones on beta receptors in the body. These medications are widely recognized in medical literature as essential treatments for various heart conditions, particularly in patients with aortic stenosis undergoing valve replacement procedures. Beta blockers reduce heart rate and blood pressure by blocking specific receptors in the heart and blood vessels, making the heart beat more slowly and with less force. They belong to the pharmacological class of sympatholytic drugs and are frequently prescribed before and after cardiac procedures to improve patient outcomes and reduce complications.

Investigated diseases

  • 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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518731-11-00Protocol codeNCT06472934Estimated enrolment700 patientsSponsorUniversitaetsspital Basel

sourced from the EU Clinical Trials Register and site verification

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