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โ† Trials
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Landiolol in Mitral Valve Surgery

RecruitingPhase 4Ages 18 Years - anyAllUniversitร  Vita-Salute San Raffaele
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Landiolol
  • Placebo
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Where

13 sites
Ospedale Cesare Arrigo
Alessandria, Italy
A. O. Ordine Mauriziano di Torino
Torino, 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

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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