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The use of Landiolol in mitral valve sUrgery: a raNdomized, controlled, double-blind triAl. (LUNA)
EU CTIS ID: 2024-515934-34-00
What this study is testing
To assess the effect of administering landiolol as cardioplegia adjuvant to reduce the occurrence of postoperative low-cardiac output syndrome.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Older than 18 years;
- Undergoing 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.
You likely can't join if
- Need for preoperative dialysis;
- 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;
See the full eligibility criteria
- Older than 18 years;
- Undergoing 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.
- Need for preoperative dialysis;
- 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.
- 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
- Refusal or inability to sign the informed consent.
- Patients with preoperative evidence of hypernatremia (serum sodium concentration: > 160 mmol/L);
- Patients with preoperative evidence of hyperchloremia (serum chloride concentration: >115 mmol/L);
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.