Heart drug shows promise in preventing post-surgery rhythm disorder
NCT ID NCT04607122
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a low-dose infusion of landiolol, a short-acting beta-blocker, could prevent atrial fibrillation in 400 non-Asian patients after cardiac surgery. Participants received either landiolol or a placebo for up to 48 hours after surgery. The goal was to see if landiolol reduces the occurrence of this common and serious complication without causing more side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Landiolol (a short-acting beta-blocker)
- What this could lead to
- If it works, this could provide a safe way to prevent a common heart rhythm problem after heart surgery, reducing hospital stays and complications.
- What could go wrong
- This is a phase 3 trial, but previous positive results were in Japanese patients only. It may not work as well in non-Asian populations, and side effects like low blood pressure or slow heart rate are possible.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
400 people
The number who actually took part.
- Started
-
Jan 2021
- Finished
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Jul 2023
- 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
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65 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Non-Asian, * Undergoing cardiac surgery with CPB, * Left ventricular ejection fraction (LVEF) ≥ 40%, * Having signed a written informed consent form, * Affiliation to the social security system. Preoperative Exclusion Criteria: * Paroxystic or persistant atrial fibrillation before surgery, * Preoperative contraindication to beta-blockers, * Known hypersensitivity to landiolol, * Severe conduction disorders (atrio-ventricular conduction block), * A mental or linguistic inability to understand the study, * Dying patient, * Patient under protection of the adults (guardianship, curators or safeguard of justice), * Patient included or planning to be included in another research protocol relating to medications. Postoperative Exclusion Criteria: \- Postoperative contraindication to beta-blockers: severe sinus bradycardia requiring pacing, postcardiotomy low cardiac output requiring inotropic agents (noradrenaline being not considered as an inotropic agent), severe hypotension, severe acute pulmonary hypertension, reoperation for significant bleeding (\> 200 ml/h), acute respiratory distress syndrome defined by increased oxygen dependence, a PaO2/FiO2 ratio \< 200, polypnea \> 30 /min, signs of respiratory distress (retractions, thoraco-abdominal asynchrony).
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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.
Contacts and locations
Locations
-
CMC Ambroise Paré
Neuilly-sur-Seine, 92200, France
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Centre Cardiologique du Nord
Saint-Denis, 93200, France
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Hôpital Privé Jacques Cartier
Massy, 91300, France
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