Clinical trial • Phase III • Cardiology

LEVOSIMENDAN for Functional tricuspid regurgitation

Phase III trial of LEVOSIMENDAN for Functional tricuspid regurgitation.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Functional tricuspid regurgitation
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
30-09-2024
First CTIS Authorization Date
03-12-2024

Trial design

ZIMINO 2,5 mg/ml, solution à diluer pour perfusion (active substance: levosimendan) — intravenous infusion; product details indicate dose unit mg/Kg and max daily dose amount 0.29 mg/Kg. Comparator: Placebo of ZIMINO (glucose 5%).-controlled Phase III trial across 25 sites in France.

Comparator
ZIMINO 2,5 mg/ml, solution à diluer pour perfusion (active substance: levosimendan) — intravenous infusion; product details indicate dose unit mg/Kg and max daily dose amount 0.29 mg/Kg. Comparator: Placebo of ZIMINO (glucose 5%).
Target Sample Size
230
Trial Duration For Participant
90

Eligibility

Recruits 230 Vulnerable populations are not selected. Patients under guardianship are explicitly excluded. Written signed informed consent is required from participants (age ≥ 18 years). No assent process is described for minors (trial includes adults only)..

Pregnancy Exclusion
Pregnant or breastfeeding women
Vulnerable Population
Vulnerable populations are not selected. Patients under guardianship are explicitly excluded. Written signed informed consent is required from participants (age ≥ 18 years). No assent process is described for minors (trial includes adults only).

Inclusion criteria

  • {"criterion_text":"- Age ≥ 18 years\n- Written signed informed consent\n- Affiliation to the French health care system (Sécurité Sociale)\n- Patient referred to cardiac surgery for correcting severe to moderate functional tricuspid regurgitation\n- Severe tricuspid regurgitation was defined (one item required) : a. or an effective regurgitant orifice (ERO)>20mm², b. or vena contracta width >7mm, c. or systolic hepatic vein flow blunting or reserval."}

Exclusion criteria

  • {"criterion_text":"- Severe hypotension defined by systolic blood pressure <90mmHg\n- Left ventricular obstruction\n- Allergy to levosimedan\n- Current participation in other investigational drug or device studies or being in the exclusion period at the end of a previous study involving human participants, if applicable\n- Pregnant or breastfeeding women\n- Females of childbearing potential without effective method of birth control\n- Patient on AME (state medical aid) unless exemption from affiliation\n- Patient under guardianship (under “tutelle or curatelle or sauvegarde de justice or mandat de protection futur activé ou habilitation familiale” according to French law\n- Severe tachycardia (>150/bpm)\n- History of torsade de pointe\n- Organic renal failure defined by creatinine clearance <30mL/min\n- Recent endocarditis (<3 months)\n- Recent myocardial infarction (<3 months)\n- Tricuspid valve perforation or prolapse\n- Cardiogenic shock requiring dobutamine support or cardiac assistance\n- Severe liver injury (CHILD C)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary end point is a composite element reflecting low cardiac output syndrome at 90 days: - 1) Catecholamine infusion persisting beyond 48 hours after cardiac surgery, - 2) Need for circulatory mechanical assist devices in the postoperative period, - 3) Need for renal replacement therapy at any time during intensive care unit stay.","definition_or_measurement_approach":"Composite reflecting low cardiac output syndrome at 90 days measured by occurrence of any of: catecholamine infusion persisting beyond 48 hours after cardiac surgery; requirement for circulatory mechanical assist devices postoperatively; requirement for renal replacement therapy at any time during ICU stay."}

Secondary endpoints

  • {"endpoint_text":"- 1) Mortality at day 90, 2) Each component of the primary end point, 3) The study drug safety was assessed by recording of the incidence refractory hypotension was defined as a failure to increase mean arterial pressure above 60 mmHg despite optimal management.","definition_or_measurement_approach":"Mortality measured at day 90; each component measured as per primary endpoint definitions; safety assessed by recording incidence of refractory hypotension defined as failure to increase mean arterial pressure above 60 mmHg despite optimal management."}

Recruitment

Planned Sample Size
230
Recruitment Window Months
39
Consent Approach
Written signed informed consent required from each participant (Age ≥ 18 years). A patient information and informed consent form document (L1_SIS and ISF Patient) is listed but languages and age-specific documents are not specified in the record.

Geography

Total Number Of Sites
25
Total Number Of Participants
230

France

Earliest CTIS Part Ii Submission Date
08-10-2024
Latest Decision Or Authorization Date
22-02-2026
Processing Time Days
502
Number Of Sites
25
Number Of Participants
230

Sites

Site Name
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Department Name
Intensive Care of Cardiology
Contact Person Name
Martin KLOECKNER
Contact Person Email
m.kloeckner@ghpsj.fr
Site Name
Chorale Du Centre Hospitalier De Lens
Department Name
Cardiology
Contact Person Name
Ilir HYSI
Contact Person Email
ilirhysi@gmail.com
Site Name
Institut Mutualiste Montsouris
Department Name
Cardiology
Contact Person Name
Christelle DIAKOV
Contact Person Email
christelle.diakov@imm.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Cardiology
Contact Person Name
Chadi ALUDAAT
Contact Person Email
Chadi.Aludaat@chu-rouen.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Cardiology
Contact Person Name
Gaspard SUC
Contact Person Email
Gaspard.suc@aphp.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Cardiovascular Surgery
Contact Person Name
Nicolas D’OSTREVY
Contact Person Email
nicolasdos@hotmail.com
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Cardiology
Contact Person Name
Yoann BOHBOT
Contact Person Email
Bohbot.yohann@chu-amiens.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Cardiac Surgery
Contact Person Name
Thierry BOURGUIGNON
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Thoracic and Cardiovascular Surgery
Contact Person Name
Amedeo ANSELMI
Contact Person Email
amedeo.anselmi@chu-rennes.fr
Site Name
Hospices Civils De Lyon
Department Name
Cardiac Surgery and Transplantation
Contact Person Name
Matteo POZZI
Contact Person Email
matteo.pozzi@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Heart-Lung-Vascular Hub
Contact Person Name
Pierre CORBI
Contact Person Email
pierre.corbi@chu-poitiers.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Cardiology
Contact Person Name
Thierry FOLLIGUET
Contact Person Email
Thierry.folliguet@aphp.fr
Site Name
Clinique Du Millenaire
Department Name
Anesthesia and Intensive Care
Contact Person Name
Emmanuel LORNE
Contact Person Email
e.lorne@free.fr
Site Name
Societe D'Exploitation Du Centre Cardiologique Du Nord
Department Name
Cardiology
Contact Person Name
Julien DREYFUS
Contact Person Email
dreyfusjulien@yahoo.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Cardiology
Contact Person Name
François ROUBILLE
Contact Person Email
f-roubille@chu-montpellier.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Cardiology
Contact Person Name
Aurélien SEEMANN
Contact Person Email
a.seemann@cardiosaintgatien.fr
Site Name
Hopital Saint Joseph
Department Name
Cardiology
Contact Person Name
Laureline FAIVRE
Site Name
CHU Besancon
Department Name
Cardiac Surgery
Contact Person Name
Sidney CHOCRON
Contact Person Email
sidney.chocron@chu-besancon.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Anesthesia and Intensive Care
Contact Person Name
Bertrand ROZEC
Contact Person Email
Bertrand.rozec@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Thoracic and Cardiovascular Surgery
Contact Person Name
Vito Giovanni RUGGIERI
Contact Person Email
vgruggieri@chu-reims.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Cardiac Surgery and Intensive Care
Contact Person Name
Philippe ESTAGNASIE
Contact Person Email
philippe.estagnasie@wanadoo.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Cardiac Surgery
Contact Person Name
François LABASTE
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Enchocardiography Laboratory
Contact Person Name
Julien TERNACLE
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Cardiovascular and thoracic surgery
Contact Person Name
Olivier BOUCHOT
Contact Person Email
olivier.bouchot@chu-dijon.fr
Site Name
Hopital Prive Jacques Cartier
Department Name
Intensive Care
Contact Person Name
Julien AMOUR
Contact Person Email
profjulien.amour@gmail.com

Sponsor

Primary sponsor

Full Name
Assistance Publique Hopitaux De Paris
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
ZIMINO 2,5 mg/ml, solution à diluer pour perfusion
Active Substance
LEVOSIMENDAN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation number 34009 300 210 4 0 in France)
Maximum Dose
0.29 mg/Kg
Investigational Product Name
Placebo of ZIMINO (glucose 5%)
Modality
Other

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