RecruitingPhase 4NCT06793670

Landiolol in Mitral Valve Surgery

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


Sponsor

Università Vita-Salute San Raffaele

Enrollment

1,500 participants

Start Date

Jan 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Chronic mitral regurgitation is the most common valvular abnormality worldwide, it occurs in 10% of the general population and its prevalence increases with age. When left untreated, it can lead to left ventricular dysfunction and cause disabling symptoms (e.g., fatigue and dyspnea), life-threatening complications (e.g., ventricular dilation, congestive heart failure) and death. Surgical correction of chronic mitral regurgitation before irreversible changes happen can be curative. Open surgical valve repair or replacement are accomplished through cardiopulmonary bypass and cardioplegic arrest. Myocardial protection is essential to guarantee an uneventful perioperative course since a not-well protected heart may lead to postoperative low-cardiac output syndrome. This occurs in 30% of high-risk patients who undergo elective cardiac surgery and is associated with 20% mortality. Cardioplegia preserves the heart during ischemic arrest by reducing its metabolic demand. The most effective cardioplegia for protection in adult cardiac surgery remains unknown and improving the protection of the heart during the ischemic arrest may potentially improve patients' postoperative outcomes. Pharmacological adjuvants to the cardioplegic solutions have been tested to mitigate the ischaemic-reperfusion injury following cardiac surgery. Ultra-short acting beta-blockers (e.g., esmolol, landiolol) decrease intraoperative myocardial metabolic demand and suppress the sympathetic response to surgical stimuli while exhibiting limited adverse effects. Few studies with limited sample size investigated the role of ultra-short acting beta-blockers in reducing perioperative ischaemia and arrhythmia after cardiac surgery. When ultra-short acting beta-blockers were administered before aortic cross-clamping and as cardioplegia adjuvant we observed a trend towards a reduction in postoperative low-cardiac output syndrome (13/98 vs 6/102; p=0.08) and in the rate of hospital re-admission at one year (26/95 v 16/96, p=0.08) with an increase in the number of patients with ejection fraction \>60% at hospital discharge (4/95 vs 11/92, p=0.06) (Zangrillo 2021). However, despite a growing body of literature exploring the role of ultra-short acting beta-blockers in enhancing myocardial protection during on-pump cardiac surgery, further high-quality evidence is needed before this practice can be established as standard routine care. Hence, we designed a randomized, placebo-controlled trial involving 1500 patients undergoing open mitral valve surgery to assess the effect of administering landiolol as cardioplegia adjuvant to reduce the occurrence of postoperative low-cardiac output syndrome. Successful results would have a significant impact on short and long-term complications.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether adding a short-acting heart rate medication (landiolol) during mitral valve surgery can protect the heart and reduce complications in patients with already weakened hearts. **You may be eligible if...** - You are over 18 years old - You are scheduled for elective mitral valve repair or replacement surgery using a heart-lung bypass machine - Your heart shows signs of enlargement or reduced pumping function before surgery - You have given signed informed consent **You may NOT be eligible if...** - You need dialysis before surgery - You have severe liver disease (Child-Pugh class C) - You have had unusual reactions to beta-blocker medications - Your surgery is urgent or emergency - You are pregnant - You have very slow heart rate, high-grade heart block, severe low blood pressure, cardiogenic shock, severe pulmonary hypertension, or untreated pheochromocytoma - You have an active asthma attack - You have abnormal sodium or chloride blood levels before surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLandiolol

Intravenous infusion of landiolol

DRUGPlacebo

Intravenous infusion of saline solution of NaCl 0.9%


Locations(13)

Ospedale Cesare Arrigo

Alessandria, Piedmont, Italy

A. O. Ordine Mauriziano di Torino

Torino, TO, Italy

AOU di Alessandria

Alessandria, Italy

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

Catania, Italy

AOU Careggi

Florence, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

Foggia, Italy

IRCCS San Martino di Genova

Genova, Italy

Ospedale San Raffaele

Milan, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

AOU Policlinico Paolo Giaccone

Palermo, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

AOR San Carlo

Potenza, Italy

Maria Cecilia Hospital S.p.A.

Ravenna, Italy

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NCT06793670


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