Actively Recruiting
The Use of Landiolol in Mitral Valve Surgery: a Randomized, Controlled, Double-blind Trial (LUNA)
Led by Università Vita-Salute San Raffaele · Updated on 2025-12-29
1500
Participants Needed
13
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of landiolol, an ultra-short acting beta-blocker, as an additional treatment during open mitral valve surgery to reduce the occurrence of postoperative low-cardiac output syndrome (LCOS). Chronic mitral regurgitation is a common heart valve problem that can lead to serious complications and death if untreated. This Phase 4 randomized, controlled, double-blind trial aims to provide high-quality evidence on whether landiolol improves heart protection during surgery and reduces complications after surgery. The study compares two groups: one receiving landiolol as a low-dose continuous infusion until aortic cross-clamping, followed by intravenous boluses before cross-clamping and added to the cardioplegic solution; the other group receives a placebo saline solution in the same manner. The intervention occurs during the operation, with landiolol given intravenously to evaluate its effect on heart protection while the heart is stopped. The study includes 1500 patients undergoing open mitral valve repair or replacement surgery. Participants will be monitored until intensive care unit discharge, hospital discharge, and one year after surgery. Researchers will assess the occurrence of LCOS, the need for prolonged catecholamine infusion, changes in cardiac biomarkers and heart function, hospital readmissions for heart reasons, quality of life questionnaires, and mortality. The primary outcome is the reduction of LCOS until ICU discharge, about 4 days. Follow-up includes assessments up to one year post-surgery to evaluate longer-term outcomes.
CONDITIONS
Brief Title
Landiolol in Mitral Valve Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Older than 18 years
- Scheduled for elective mitral valve repair or replacement surgery with planned cardiopulmonary bypass
- Preoperative evidence of left ventricular end-systolic diameter greater than 40 mm and/or left ventricular end-diastolic diameter greater than 60 mm and/or left ventricular ejection fraction less than 60%
- Signed informed consent
You will not qualify if you...
- Need for preoperative dialysis
- Severe liver dysfunction (Child-Pugh class C)
- History of unusual response to beta-blockers
- Urgent or emergency surgery
- Mechanical circulatory support before surgery (except IABP)
- Pregnancy confirmed by test within 72 hours before surgery
- Hypernatremia (serum sodium concentration over 160 mmol/L)
- Hyperchloremia (serum chloride concentration over 115 mmol/L)
- Hypersensitivity to the study drug or its ingredients
- Severe bradycardia (less than 50 beats per minute), sick sinus syndrome, severe atrioventricular conduction disorders without pacemaker
- Cardiogenic shock, severe low blood pressure (MAP less than 50 mmHg), decompensated heart failure, or severe pulmonary hypertension (PAPs over 70 mmHg)
- Untreated phaeochromocytoma
- Acute asthmatic attack
- Severe, uncorrectable metabolic acidosis
- Participation in another clinical trial with investigational drug within 30 days or 5 half-lives of that drug
- Planned use of ultra-short acting beta-blockers during surgery
- Refusal or inability to sign informed consent
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During surgery
Participants receive an intravenous infusion of either landiolol or placebo during mitral valve surgery.
1 intraoperative visit
Duration - Up to 10 days
Participants are monitored for postoperative recovery and cardiac function until hospital discharge.
Approximately 4 to 10 visits depending on ICU and hospital stay
Duration - 1 year
Participants are followed for up to 1 year to assess cardiac health and quality of life.
Periodic visits or assessments up to 1 year
Trial Site Locations
Total: 13 locations
1
Ospedale Cesare Arrigo
Alessandria, Piedmont, Italy, 15121
Actively Recruiting
2
A. O. Ordine Mauriziano di Torino
Torino, TO, Italy
Actively Recruiting
3
AOU di Alessandria
Alessandria, Italy
Actively Recruiting
4
Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco"
Catania, Italy, 95123
Actively Recruiting
5
AOU Careggi
Florence, Italy
Actively Recruiting
6
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
Foggia, Italy
Actively Recruiting
7
IRCCS San Martino di Genova
Genova, Italy
Actively Recruiting
8
Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
9
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Actively Recruiting
10
AOU Policlinico Paolo Giaccone
Palermo, Italy
Actively Recruiting
11
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Actively Recruiting
12
AOR San Carlo
Potenza, Italy
Actively Recruiting
13
Maria Cecilia Hospital S.p.A.
Ravenna, Italy
Actively Recruiting
Research Team
F
Fabrizio Monaco, MD
G
Giovanni Landoni, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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