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Landiolol in Mitral Valve Surgery

NCT ID: NCT06793670

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-28

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Failure Low Cardiac Output Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Landiolol

intraoperative landiolol, first as low-dose continuous infusion (5 mcg/kg/min) until aortic cross clamping, followed by an intravenous bolus (0.3 mg/kg) after aortic cannulation (but still before aortic cross-clamping) and a further intravenous bolus dose of 0.3 mg/kg as cardioplegia adjuvant added to the first administered cardioplegic solution.

Group Type EXPERIMENTAL

Landiolol

Intervention Type DRUG

Intravenous infusion of landiolol

Placebo

intraoperative equivolume placebo normal saline solution, first as low-dose continuous infusion until aortic cross clamping, followed by an intravenous bolus after aortic cannulation and a further equivolume quantity added to the first administered cardioplegic solution.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intravenous infusion of saline solution of NaCl 0.9%

Interventions

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Landiolol

Intravenous infusion of landiolol

Intervention Type DRUG

Placebo

Intravenous infusion of saline solution of NaCl 0.9%

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università Vita-Salute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Giovanni Landoni

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ospedale Cesare Arrigo

Alessandria, Piedmont, Italy

Site Status RECRUITING

A. O. Ordine Mauriziano di Torino

Torino, TO, Italy

Site Status RECRUITING

AOU di Alessandria

Alessandria, , Italy

Site Status RECRUITING

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

Catania, , Italy

Site Status RECRUITING

AOU Careggi

Florence, , Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

Foggia, , Italy

Site Status RECRUITING

IRCCS San Martino di Genova

Genova, , Italy

Site Status RECRUITING

Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status RECRUITING

AOU Policlinico Paolo Giaccone

Palermo, , Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Site Status RECRUITING

AOR San Carlo

Potenza, , Italy

Site Status RECRUITING

Maria Cecilia Hospital S.p.A.

Ravenna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Fabrizio Monaco, MD

Role: CONTACT

Phone: 0226436154

Email: [email protected]

Giovanni Landoni, Prof.

Role: CONTACT

Phone: 0226436154

Email: [email protected]

Facility Contacts

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Giulia Maj, MD

Role: primary

Giulia Maj, MD

Role: backup

Marco Comis, MD

Role: primary

Andrea Aduo, MD

Role: primary

Cristina Santonocito

Role: primary

Raffaele Mandarano, MD

Role: primary

Domenico Paparella, MD

Role: primary

Simona Silvetti, MD

Role: primary

Fabrizio Monaco, MD

Role: primary

Giovanni Landoni, prof

Role: backup

Marcello Guarnieri, MD

Role: primary

Andrea Cortegiani, MD

Role: primary

Fabio Guarracino, MD

Role: primary

Gianluca Paternoster, Prof

Role: primary

Lorenzo Mantovani, MD

Role: primary

Other Identifiers

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PNRR-MCNT2-2023-12377946

Identifier Type: -

Identifier Source: org_study_id