Keep or pause the heart pill? trial probes beta-blocker safety during valve replacement
NCT ID NCT05721170
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 348 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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First Department of Cardiology, National and Kapodistrian University of Athens
RECRUITINGAthens, Attica, 11527, Greece
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Nicosia General Hospital
RECRUITINGNicosia, Cyprus
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