Using Landiolol to improve outcomes in mitral valve surgery

The Use of Landiolol in Mitral Valve sUrgery: a raNdomized, Controlled, Double-blind triAl (LUNA)

This study is testing if the medication Landiolol can help people having mitral valve surgery recover better and have fewer heart problems afterward.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Università Vita-Salute San Raffaele (Academic / other)
• Locations: 13 sites (Alessandria, Piedmont and 12 other locations)
• Trial ID: NCT06793670 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of Landiolol, a beta-blocker, in patients undergoing elective mitral valve repair or replacement surgery. The study aims to assess whether Landiolol can provide better myocardial protection during surgery, potentially reducing the incidence of postoperative low cardiac output syndrome. Participants will be monitored for their heart function and overall recovery following the surgical procedure. The trial includes a placebo group for comparison to evaluate the effectiveness of Landiolol.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years scheduled for elective mitral valve surgery with specific preoperative heart function criteria.

Not a fit: Patients requiring urgent surgery, those with severe liver dysfunction, or those with a history of adverse reactions to beta-blockers may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of postoperative complications and improve recovery outcomes for patients undergoing mitral valve surgery.

How similar studies have performed: While the use of beta-blockers in cardiac surgery is established, the specific application of Landiolol in this context is novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Alessandria, Piedmont and 12 other locations

• Ospedale Cesare Arrigo — Alessandria, Piedmont, Italy (Recruiting)
• A. O. Ordine Mauriziano di Torino — Torino, To, Italy (Recruiting)
• AOU di Alessandria — Alessandria, Italy (Recruiting)
• Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco" — Catania, Italy (Recruiting)
• AOU Careggi — Florence, Italy (Recruiting)
• Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia — Foggia, Italy (Recruiting)
• IRCCS San Martino di Genova — Genova, Italy (Recruiting)
• Ospedale San Raffaele — Milan, Italy (Recruiting)
• ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy (Recruiting)
• AOU Policlinico Paolo Giaccone — Palermo, Italy (Recruiting)
• Azienda Ospedaliero Universitaria Pisana — Pisa, Italy (Recruiting)
• AOR San Carlo — Potenza, Italy (Recruiting)
• Maria Cecilia Hospital S.p.A. — Ravenna, Italy (Recruiting)

Study contacts

• Study coordinator: Fabrizio Monaco, MD

Conditions Cardiac Failure; Low Cardiac Output Syndrome