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Heart drug shows promise in preventing post-surgery rhythm disorder

NCT ID NCT04607122

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

65 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.

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

  • Centre Cardiologique du Nord

    Saint-Denis, 93200, France

  • Hôpital Privé Jacques Cartier

    Massy, 91300, France

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