Using Landiolol to improve outcomes in mitral valve surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of Landiolol, a beta-blocker, in patients undergoing elective mitral valve repair or replacement surgery. The study aims to assess whether Landiolol can provide better myocardial protection during surgery, potentially reducing the incidence of postoperative low cardiac output syndrome. Participants will be monitored for their heart function and overall recovery following the surgical procedure. The trial includes a placebo group for comparison to evaluate the effectiveness of Landiolol.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ospedale Cesare Arrigo
  Alessandria, Piedmont, Italy Recruiting
• A. O. Ordine Mauriziano di Torino
  Torino, To, Italy Recruiting
• AOU di Alessandria
  Alessandria, Italy Recruiting
• Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco"
  Catania, Italy Recruiting
• AOU Careggi
  Florence, Italy Recruiting
• Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
  Foggia, Italy Recruiting

Study contacts

• Study coordinator: Fabrizio Monaco, MD
• Email: monaco.fabrizio@hsr.it
• Phone: 0226436154

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Can Cardiac Cycle Efficiency predict high-dose vasoactive-inotropic needs after open-heart surgery?

  This study tests whether Cardiac Cycle Efficiency measured after coming off bypass can predict which adults will need high doses of vasoactive and inotropic meds in the first 24 hours after open-heart surgery.

  Recruiting Bursa City Hospital · Nilufer, Bursa · NCT07926360

• Heart remodeling after endovascular aortic repair

  We will see if endovascular aortic repair changes heart size, shape, or function in adults treated for aortic aneurysms or related aortic problems.

  Recruiting Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa · Lisbon and 1 other locations · NCT07415447

• Platelet population changes during ECMO circulatory support

  This will test whether the proportions of different platelet types change during ECMO in adults with cardiac or respiratory failure.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07334457

• Personalizing adult heart transplant immunosuppression using blood microRNA levels

  This project will try to use blood microRNA patterns to monitor immune status in adults after heart transplant and predict who will develop infection or rejection.

  Recruiting at 6 sites Northwestern University · Los Angeles, California and 5 other locations · NCT06939751

• Social prescribing to help women with heart failure stick to treatments and avoid hospital visits.

  This project will try social prescribing—connecting women with heart failure to community supports—to help them take heart medicines and reduce hospitalizations.

  Recruiting McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec and 1 other locations · NCT06628973

• Identifying microRNAs to improve heart transplant outcomes in children

  This study is trying to find specific microRNAs in the blood of children who have had heart transplants to see if they can help predict infections and rejection of the new heart.

  Recruiting at 7 sites Northwestern University · Aurora, Colorado and 6 other locations · NCT06532890

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.