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Cardiac FailurePhase 4LUNANCT06793670

Landiolol in Mitral Valve Surgery

A Phase 4 study testing Landiolol in people with Cardiac Failure and Low Cardiac Output Syndrome, run by Università Vita-Salute San Raffaele at 13 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Failure, Low Cardiac Output Syndrome
What is being tested?
Landiolol
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,500 participants
Where
13 sitesItaly
Study dates
28 Jan 2025to Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 17Show fewer
  • 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.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Fabrizio Monaco, MD contact

0226436154 ext. +39

monaco.fabrizio@hsr.it

Giovanni Landoni, Prof. contact

0226436154 ext. +39

landoni.giovanni@hsr.it

13 sites in 1 country

Italy13 sites, 13 recruiting

  • Ospedale Cesare Arrigo

    Alessandria, Piedmont, 15121

    Giulia Maj, MD

    Giulia Maj, MD, giulia.maj@ospedale.al.it

    Recruiting

  • AOU di Alessandria

    Alessandria

    Andrea Aduo, MD, aaudo@ospedale.al.it

    Recruiting

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

    Catania, 95123

    Cristina Santonocito, +393496332052, cristina.santonocito@gmail.com

    Recruiting

  • AOU Careggi

    Florence

    Raffaele Mandarano, MD, mandaranor@aou-careggi.toscana.it

    Recruiting

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

    Foggia

    Domenico Paparella, MD, domenico.paparella@unifg.it

    Recruiting

  • IRCCS San Martino di Genova

    Genova

    Simona Silvetti, MD, lu.simo@icloud.com

    Recruiting

  • Ospedale San Raffaele

    Milan, 20132

    Fabrizio Monaco, MD, 0226436154 ext. +39, monaco.fabrizio@hsr.it

    Giovanni Landoni, prof, 0226436154 ext. +39, landoni.giovanni@hsr.it

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan

    Marcello Guarnieri, MD, marcello.guarnieri@ospedaleniguarda.it

    Recruiting

  • AOU Policlinico Paolo Giaccone

    Palermo

    Andrea Cortegiani, MD, andrea.cortegiani@unipa.it

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa

    Fabio Guarracino, MD, fabioguarracino@gmail.com

    Recruiting

  • AOR San Carlo

    Potenza

    Gianluca Paternoster, Prof, paternostergianluca@gmail.com

    Recruiting

  • Maria Cecilia Hospital S.p.A.

    Ravenna

    Lorenzo Mantovani, MD, lmantovani@gvmnet.it

    Recruiting

  • A. O. Ordine Mauriziano di Torino

    Torino, TO

    Marco Comis, MD, comismarco@gmail.com

    Recruiting

Other trials in Italy

About this study

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

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.

Being tested
Landiolol, Placebo
Medical subject headings
Heart Failure, Cardiac Output, Low

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LandiololDrug

    Intravenous infusion of landiolol

  • PlaceboDrug

    Intravenous infusion of saline solution of NaCl 0.9%

Study groups in NCT06793670
Study groupRoleWhat they receive
LandiololExperimentalintraoperative 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.
Receives: Drug: Landiolol
PlaceboPlacebo comparatorintraoperative 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction of the occurrence of postoperative low-cardiac output syndrome (LCOS)

    The primary outcome will be the reduction of the occurrence of postoperative low-cardiac output syndrome, defined following Cholley et al. 2017 JAMA as the presence of at least one of the following:

    1. need of prolonged catecholamine infusion (persisting beyond 48 hours after the initiation of the study drug);
    2. need of circulatory mechanical assist devices in the postoperative period (if an intra-aortic balloon pump was inserted preventively, the criteria will be met if patients are not weaned from the balloon within 96 hours);
    3. need for renal replacement therapy at any time during the intensive care unit stay.

    Measured: Until ICU discharge, an average of 4 days

Secondary outcomes (6)

  1. Patients requiring prolonged (>48 h) catecholamine infusion

    Measured: Until ICU discharge, an average of 4 days

  2. Patients with increased postoperative cardiac biomarkers (Troponin I or T)

    Measured: Up to 48 hours.

  3. Patients with a reduction in left ventricular ejection fraction

    Measured: Until hospital discharge, an average of 10 days

  4. Number of patients readmitted to hospital for cardiac reasons

    Measured: 1 year

  5. EQ-5D-5L questionnaire

    Measured: 1 year

  6. Death

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2025
  2. Study start28 Jan 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06793670
Sponsor's protocol ID
PNRR-MCNT2-2023-12377946
Acronym
LUNA
Status last verified
Dec 2025
First submitted
15 Jan 2025
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Landiolol in people with Cardiac Failure and Low Cardiac Output Syndrome, run by Università Vita-Salute San Raffaele at 13 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fabrizio Monaco, MD (0226436154 ext. +39, monaco.fabrizio@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of the occurrence of postoperative low-cardiac output syndrome (LCOS) (time frame: Until ICU discharge, an average of 4 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06793670.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.

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