Clinical trial • Phase IV • Cardiology

LANDIOLOL HYDROCHLORIDE for Low cardiac output syndrome

Phase IV trial of LANDIOLOL HYDROCHLORIDE for Low cardiac output syndrome.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Low cardiac output syndrome
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
22-07-2024
First CTIS Authorization Date
12-11-2024

Trial design

Randomised, placebo: sodio cloruro 0,9% (0.9% saline solution) intravenous infusion (placebo). (no detailed dose/schedule specified for comparator in the available data.)-controlled Phase IV trial in Italy.

Randomised
Yes
Comparator
Placebo: SODIO CLORURO 0,9% (0.9% saline solution) intravenous infusion (placebo). (No detailed dose/schedule specified for comparator in the available data.)
Target Sample Size
1500

Eligibility

Recruits 1500 No vulnerable population selected. Trial enrols adults only (Older than 18 years); informed consent is required (Signed informed consent). Subject information and informed consent forms for adults are provided (adult ICF documents present). No paediatric assent or under-18 consent arrangements are indicated..

Pregnancy Exclusion
Pregnancy as documented by a pregnancy test performed in the last 72h before surgery
Vulnerable Population
No vulnerable population selected. Trial enrols adults only (Older than 18 years); informed consent is required (Signed informed consent). Subject information and informed consent forms for adults are provided (adult ICF documents present). No paediatric assent or under-18 consent arrangements are indicated.

Inclusion criteria

  • {"criterion_text":"- Older than 18 years;\n- Undergoing elective mitral valve repair or replacement surgery with planned cardiopulmonary bypass via midline sternotomy or minithoracotomy;\n- 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%;\n- Signed informed consent."}

Exclusion criteria

  • {"criterion_text":"- Need for preoperative dialysis;\n- Patients with hypersensitivity to the active substance or to any of the excipients;\n- 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;\n- Patients with cardiogenic shock, severe hypotension (MAP<50 mmHg), decompensated heart failure or severe pulmonary hypertension (PAPs >70 mmHg);\n- Patients with non-treated phaeochromocytoma;\n- Patients with acute asthmatic attack;\n- Patients with severe, uncorrectable metabolic acidosis.\n- 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.\n- Hepatic dysfunction (defined as Child-Pugh class C);\n- History of previous unusual response to beta-blockers;\n- Urgent or emergency surgery;\n- Patient already in need of mechanical circulatory support before surgery (except for IABP);\n- Pregnancy as documented by a pregnancy test performed in the last 72h before surgery\n- Refusal or inability to sign the informed consent.\n- Patients with preoperative evidence of hypernatremia (serum sodium concentration: > 160 mmol/L);\n- Patients with preoperative evidence of hyperchloremia (serum chloride concentration: >115 mmol/L);"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary outcome will be the reduction of the occurrence of postoperative low-cardiac output syndrome, defined following a recent JAMA publication (Cholley 2017) as the presence of at least one of the following:","definition_or_measurement_approach":"Composite definition referencing Cholley 2017; occurrence defined by presence of at least one of the listed components."}
  • {"endpoint_text":"- need of prolonged catecholamine infusion (persisting beyond 48 hours after the initiation of the study drug);","definition_or_measurement_approach":"Prolonged catecholamine infusion defined as persisting beyond 48 hours after initiation of study drug."}
  • {"endpoint_text":"- need of circulatory mechanical assist devices in the postoperative period (if an intraaortic balloon pump was inserted preventively, the criteria will be met if patients are not weaned from the balloon within 96 hours);","definition_or_measurement_approach":"Use of circulatory mechanical assist devices during the postoperative period; for IABP inserted preventively, criterion met if not weaned within 96 hours."}
  • {"endpoint_text":"- need for renal replacement therapy at any time during the intensive care unit stay.","definition_or_measurement_approach":"Requirement for renal replacement therapy at any time during ICU stay."}

Secondary endpoints

  • {"endpoint_text":"- Patients requiring prolonged (>48 h) catecholamine infusion;","definition_or_measurement_approach":"Prolonged defined as >48 hours."}
  • {"endpoint_text":"- patients with increased postoperative cardiac biomarkers (Troponin I or T);","definition_or_measurement_approach":"Postoperative measurement of cardiac biomarkers Troponin I or T."}
  • {"endpoint_text":"- patients with a reduction in left ventricular ejection fraction;","definition_or_measurement_approach":""}
  • {"endpoint_text":"- number of patients readmitted to hospital for cardiac reasons;","definition_or_measurement_approach":""}
  • {"endpoint_text":"- EQ-5D-5L questionnaire;","definition_or_measurement_approach":"Health-related quality of life measured using the EQ-5D-5L questionnaire."}
  • {"endpoint_text":"- death.","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
1500
Recruitment Window Months
29
Consent Approach
Informed consent is required from participants (Signed informed consent). Subject information and ICF documents for adults are provided (adult ICF/SIS documents listed). Trial enrols adults only; consent provided by the participant. Consent materials available in English and Italian (documents for EN and IT present).

Geography

Total Number Of Sites
32
Total Number Of Participants
1500

Italy

Earliest CTIS Part Ii Submission Date
13-09-2024
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
518
Number Of Sites
32
Number Of Participants
1500

Sites

Site Name
Casa Di Cura San Michele Srl
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Giuseppe Sepolvere
Principal Investigator Email
giuseppesepolvere@gmail.com
Contact Person Name
Giuseppe Sepolvere
Contact Person Email
giuseppesepolvere@gmail.com
Site Name
Policlinico San Donato S.p.A.
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Marco Ranucci
Principal Investigator Email
marco.ranucci@grupposandonato.it
Contact Person Name
Marco Ranucci
Site Name
Mater Dei Hospital
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Giuseppe Columbo
Principal Investigator Email
pinocolumbo@gmail.com
Contact Person Name
Giuseppe Columbo
Contact Person Email
pinocolumbo@gmail.com
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Andrea Costamagna
Principal Investigator Email
andrea.costamagna@unito.it
Contact Person Name
Andrea Costamagna
Contact Person Email
andrea.costamagna@unito.it
Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Andrea Aduo
Principal Investigator Email
aaduo@ospedale.al.it
Contact Person Name
Andrea Adua
Contact Person Email
aaduo@ospedale.al.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Carola Mattelon
Principal Investigator Email
carola.matellon@asst-spedalicivili.it
Contact Person Name
Carola Mattelon
Site Name
Azienda Ospedaliera Santa Croce E Carle
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Domenico Vitale
Principal Investigator Email
vitale.d@ospedale.cuneo.it
Contact Person Name
Domenico Vitale
Contact Person Email
vitale.d@ospedale.cuneo.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Raffaele Mandarano
Principal Investigator Email
mandaranor@aou-careggi.toscana.it
Contact Person Name
Raffaele Mandarano
Site Name
Azienda Ospedaliera Regionale San Carlo
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Gianluca Paternoster
Principal Investigator Email
paternostergianluca@gmail.com
Contact Person Name
Gianluca Paternoster
Contact Person Email
paternostergianluca@gmail.com
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Marcello Guarnieri
Principal Investigator Email
marcello.guarnieri@ospedaleniguarda.it
Contact Person Name
Marcello Guarnieri
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Valentina Ajello
Principal Investigator Email
valentina.ajello@ptvonline.it
Contact Person Name
Valentina Ajello
Contact Person Email
valentina.ajello@ptvonline.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Francesco Meroi
Principal Investigator Email
francesco.meroi@asufc.sanita.fvg.it
Contact Person Name
Francesco Meroi
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Domenico Paparella
Principal Investigator Email
domenico.paparella@unifg.it
Contact Person Name
Domenico Paparella
Contact Person Email
domenico.paparella@unifg.it
Site Name
Ospedale Vito Fazzi Lecce
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Valentina fiore
Principal Investigator Email
valentinafiore00@gmail.com
Contact Person Name
Valentina fiore
Contact Person Email
valentinafiore00@gmail.com
Site Name
Universita' Degli Studi Di Verona
Department Name
Terapia Intensiva Cardiotoracovascolare
Principal Investigator Name
Lorenzo Peluso
Principal Investigator Email
lorenzopeluso80@gmail.com
Contact Person Name
Lorenzo Peluso
Contact Person Email
lorenzopeluso80@gmail.com
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Fabio Guaracino
Principal Investigator Email
fabioguarracino@gmail.com
Contact Person Name
Fabio Guaracino
Contact Person Email
fabioguarracino@gmail.com
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Filippo Maria Russo
Principal Investigator Email
filippo.russo@policlinico.mi.it
Contact Person Name
Filippo Maria Russo
Site Name
Humanitas Mirasole S.p.A.
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Paolo Angeletti
Principal Investigator Email
paolo.angeletti@humanitas.it
Contact Person Name
Paolo Angeletti
Contact Person Email
paolo.angeletti@humanitas.it
Site Name
Azienda Ospedaliero-Universitaria Sant Andre
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Francesco Federici
Principal Investigator Email
frfederici@ospedalesantandrea.it
Contact Person Name
Francesco Federici
Site Name
Azienda Unita Locale Socio Sanitaria N 8 Berica
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Diana Bertini
Principal Investigator Email
diana.bertini@aulss8.veneto.it
Contact Person Name
Diana Bertini
Contact Person Email
diana.bertini@aulss8.veneto.it
Site Name
Azienda Socio Sanitaria Territoriale Ovest Milanese
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Matteo Lucchelli
Principal Investigator Email
matteo.lucchelli@asst-ovestmi.it
Contact Person Name
Matteo Lucchelli
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Marco Comis
Principal Investigator Email
sperimentazioni@mauriziano.it
Contact Person Name
Marco Comis
Contact Person Email
sperimentazioni@mauriziano.it
Site Name
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Mauro D'Amora
Principal Investigator Email
mauro.damora@sangiovannieruggi.it
Contact Person Name
Mauro D'Amora
Site Name
Alessandro Manzoni Hospital
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Salvatore Alongi
Principal Investigator Email
s.alongi@asst-lecco.it
Contact Person Name
Salvatore Alongi
Contact Person Email
s.alongi@asst-lecco.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Simona Silvetti
Principal Investigator Email
lu.simo@icloud.com
Contact Person Name
Simona Silvetti
Contact Person Email
lu.simo@icloud.com
Site Name
Universita' Campus Bio-medico Di Roma
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Domenico Sarubbi
Principal Investigator Email
d.sarubbi@policlinicocampus.it
Contact Person Name
Domenico Sarubbi
Contact Person Email
d.sarubbi@policlinicocampus.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Fabrizio Monaco
Principal Investigator Email
monaco.fabrizio@hsr.it
Contact Person Name
Fabrizio Monaco
Contact Person Email
monaco.fabrizio@hsr.it
Site Name
Azienda Ospedaliero Universitaria Renato Dulbecco
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Federico Longhini
Principal Investigator Email
flonghini@unicz.it
Contact Person Name
Federico Longhini
Contact Person Email
flonghini@unicz.it
Site Name
Maria Cecilia Hospital S.p.A.
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Lorenzo Filippo Mantovani
Principal Investigator Email
lmantovani@gvmnet.it
Contact Person Name
Lorenzo Filippo Mantovani
Contact Person Email
lmantovani@gvmnet.it
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Andrea Cortegiani
Principal Investigator Email
andrea.cortegiani@unipa.it
Contact Person Name
Andrea Cortegiani
Contact Person Email
andrea.cortegiani@unipa.it
Site Name
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
Department Name
Anesthesia and Intensive Care
Principal Investigator Name
Paolo Severgnini
Principal Investigator Email
paolo.severgnini@uninsubria.it
Contact Person Name
Paolo Severgnini
Contact Person Email
paolo.severgnini@uninsubria.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Anaesthesia and Intensive Care Medicine
Principal Investigator Name
Cristina Santonocito
Principal Investigator Email
cristina.santonocito@gmail.com
Contact Person Name
Cristina Santonocito
Contact Person Email
cristina.santonocito@gmail.com

Sponsor

Primary sponsor

Full Name
Ospedale San Raffaele S.r.l.
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
Landiobloc 300 mg polvere per soluzione per infusione
Active Substance
LANDIOLOL HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Marketing authorisation present (marketingAuthNumber: 044274013)
Maximum Dose
0.3 mg/kg
Investigational Product Name
SODIO CLORURO 0,9% BAXTER Soluzione per infusione
Active Substance
SODIUM CHLORIDE
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Marketing authorisation present (marketingAuthNumber: 035715022)
Maximum Dose
0.3 mg/kg

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