Keep or pause the heart pill? trial probes beta-blocker safety during valve replacement

NCT ID NCT05721170

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 20, 2026 · Last updated Oct 21, 2026 · Updated 1 time

Summary

Researchers are testing whether people having transcatheter aortic valve implantation (TAVI) can safely keep taking their usual beta-blocker medicine instead of stopping it temporarily. The trial enrolls adults with severe symptomatic aortic stenosis who already take beta-blockers daily. Participants are randomly assigned to continue the drug from at least three days before TAVI through seven days after, or to pause it over the same period. The main question is whether continuing beta-blockers leads to no more new permanent pacemakers than pausing them, with heart rhythm, blood pressure stability, and survival tracked for a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
beta-blocker medication
What this could lead to
If continuing beta-blockers proves as safe as pausing them, patients could avoid the risks of stopping a heart medication before and after valve replacement.
What could go wrong
This is a focused safety question in people already on beta-blockers, not a new treatment. Continuing the drug might raise the chance of needing a pacemaker, and the trial may not settle the question for every patient.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 348 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Study population Eligibility Adults scheduled to undergo TAVI for severe symptomatic aortic stenosis are eligible when they are receiving chronic oral beta-blocker therapy and satisfy all inclusion criteria without meeting any exclusion criterion. Inclusion criteria Age 18 years or older. Severe symptomatic aortic stenosis, defined by one or more of the following: mean transvalvular gradient \>=40 mmHg, peak aortic-jet velocity \>=4.0 m/s, aortic-valve area \<=1.0 cm2, or indexed aorticvalve area \<=0.6 cm2/m2. Clinical and anatomical suitability for TAVI confirmed by the local multidisciplinary Heart Team. Current oral beta-blocker treatment for a recognized clinical indication. Ability and willingness to comply with the assigned treatment strategy and follow-up schedule. Written informed consent before any trial-specific procedure. Exclusion criteria Existing permanent pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization device. Second-degree Mobitz II, advanced second-degree or third-degree atrioventricular block at screening, unless a permanent device is already clinically indicated independently of the trial. Resting heart rate below 50 beats/min at the screening or baseline electrocardiogram. A clinical condition requiring mandatory beta-blocker continuation or mandatory withdrawal such that randomization would be unsafe or inappropriate. Active infection, including active infective endocarditis. Left-atrial or left-ventricular thrombus on imaging. Contraindication to the antithrombotic regimen required for TAVI. Known hypersensitivity to required procedural drugs, contrast media or device components that cannot be adequately managed. Estimated life expectancy below 12 months because of non-cardiac disease. Pregnancy or potential for pregnancy without reliable contraception. Comorbidity or social circumstance expected to prevent reliable assessment of the 7-day primary endpoint or scheduled follow-up. Participation in another interventional study that is considered likely to interfere with the assigned treatment or endpoint assessment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • First Department of Cardiology, National and Kapodistrian University of Athens

    RECRUITING

    Athens, Attica, 11527, Greece

  • Nicosia General Hospital

    RECRUITING

    Nicosia, Cyprus

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