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Heart drug during surgery may cut deadly complication risk

NCT ID NCT06793670

Disease control Sponsor: Università Vita-Salute San Raffaele Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if adding the drug landiolol to the fluid that protects the heart during mitral valve surgery can reduce a serious complication called low cardiac output syndrome, where the heart struggles to pump enough blood after surgery. About 1500 adults having elective mitral valve repair or replacement will be randomly assigned to receive landiolol or a placebo. The goal is to see if landiolol lowers the need for strong heart medications, mechanical support, or kidney dialysis after surgery.

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 1,500 people

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

Started

Jan 2025

Expected to finish

Dec 2027

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.

Inclusion Criteria: * Older than 18 years; * Elective mitral valve repair or replacement surgery with planned cardiopulmonary bypass via midline sternotomy or minithoracotomy; * Preoperative evidence of left ventricular end-systolic diameter \>40 mm and/or left ventricular end-diastolic diameter \>60 mm and/or left ventricular ejection fraction\<60%; * Signed informed consent. Exclusion Criteria: * Need for preoperative dialysis; * Hepatic dysfunction (defined as Child-Pugh class C); * History of previous unusual response to beta-blockers; * Urgent or emergency surgery; * Patient already in need of mechanical circulatory support before surgery (except for IABP); * Pregnancy as documented by a pregnancy test performed in the last 72h before surgery; * Patients with preoperative evidence of hypernatremia (serum sodium concentration: \> 160 mmol/L); * Patients with preoperative evidence of hyperchloremia (serum chloride concentration: \>115 mmol/L); * Patients with hypersensitivity to the active substance or to any of the excipients; * Patients with severe bradycardia (less than 50 beats per minute) sick sinus syndrome, severe atrioventricular nodal conductance disorders or 2nd -3rd degree atrioventricular block and without a pacemaker; * Patients with cardiogenic shock, severe hypotension (MAP\<50 mmHg), decompensated heart failure or severe pulmonary hypertension (PAPs \>70 mmHg); * Patients with non-treated phaeochromocytoma; * Patients with acute asthmatic attack; * Patients with severe, uncorrectable metabolic acidosis. * Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer. * Planned use of ultra-short acting beta-blockers as intraoperative cardiac protective strategy. * Refusal or inability to sign the informed consent.

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Conditions

The condition(s) this trial relates to.

Cardiac Output, Low cardiogenic shock heart failure mitral valve insufficiency

As listed by the trial registrant

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

Cardiac failure Low cardiac output syndrome

How to take part

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

  1. The places running it

    13 sites. 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

  • A. O. Ordine Mauriziano di Torino

    RECRUITING

    Torino, TO, Italy

  • AOR San Carlo

    RECRUITING

    Potenza, Italy

  • AOU Careggi

    RECRUITING

    Florence, Italy

  • AOU Policlinico Paolo Giaccone

    RECRUITING

    Palermo, Italy

  • AOU di Alessandria

    RECRUITING

    Alessandria, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, Italy

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

    RECRUITING

    Foggia, Italy

  • Azienda Ospedaliero Universitaria Pisana

    RECRUITING

    Pisa, Italy

  • Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco"

    RECRUITING

    Catania, 95123, Italy

  • IRCCS San Martino di Genova

    RECRUITING

    Genova, Italy

  • Maria Cecilia Hospital S.p.A.

    RECRUITING

    Ravenna, Italy

  • Ospedale Cesare Arrigo

    RECRUITING

    Alessandria, Piedmont, 15121, Italy

  • Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

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