Landiolol in Mitral Valve Surgery

Launched by UNIVERSITÀ VITA-SALUTE SAN RAFFAELE · Jan 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called landiolol in patients undergoing surgery for mitral valve problems. Specifically, it aims to see if adding landiolol to the standard treatment during surgery can help reduce the risk of a serious condition called low-cardiac output syndrome, which can happen after surgery and can lead to complications. The trial will involve about 1,500 patients who are scheduled for elective mitral valve repair or replacement surgery. To participate, patients must be over 18 years old and have certain heart conditions, like enlarged heart chambers or reduced heart function.

Participants in this trial can expect to receive either landiolol or a placebo (a harmless substance with no active medication) during their surgery. The goal is to determine if landiolol can help protect the heart during the procedure and improve recovery outcomes. It's important to know that there are specific criteria for who can join the study, including certain health conditions that might exclude someone from participating. Overall, if successful, this research could lead to better care and fewer complications for patients undergoing heart surgery in the future.

Gender

ALL

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.