Informations générales (source: ClinicalTrials.gov)
Levosimendan Versus Placebo Before Tricuspid Valve Surgery in Patients With Right Ventricular Dysfunction
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
janvier 2023
janvier 2025
15 août 2025
A Prospective, multicenter, randomized (two arms, parallel groups); double-blind,
placebo-controlled in order to assess the ability of preoperative levosimendan to prevent
post-operative low cardiac output in high-risk patients referred to cardiac surgery for
correcting functional tricuspid regurgitation. The primary end point is a composite
element that includes peri-operative mortality and low cardiac output syndrome at day-90:
1) catecholamine infusion persisting beyond 48 hours after cardiac surgery, 2) the need
for circulatory mechanical assist devices in the postoperative period, 3) or the need for
renal replacement therapy at any time during intensive care unit stay. If a patient had
at least 1 of these criteria, he or she was considered as meeting the primary end
point.The secondary end points were 1) each component of the primary end point, and 2)
the study drug safety defined as refractory hypotension.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CENTRE CARDIOLOGIQUE DU NORD | LIM Pascal | 01/11/2025 07:47:56 | Contacter | ||
| CLINIQUE CHIRURGICAL AMBROISE PARE | LIM Pascal | 01/11/2025 07:47:56 | Contacter | ||
| HOPITAL MARIE LANNELONGUE | LIM Pascal | 01/11/2025 07:47:56 | Contacter | ||
| HOPITAL PRIVE JACQUES CARTIER | LIM Pascal | 01/11/2025 07:47:55 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 01/11/2025 07:47:50 | Contacter | |||
| AP-HP - Hôpital Europeen Georges Pompidou | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
Critères
Tous
Inclusion Criteria:
- Patients referred for an isolated or a combined surgical correction of functional
moderate to severe tricuspid regurgitation [effective regurgitant orifice
(ERO)>20mm², or systolic hepatic vein flow blunting or reversal]
- Written signed informed consent
- Affiliation to the French health care system (Sécurité Sociale)
- Patients referred for an isolated or a combined surgical correction of functional
moderate to severe tricuspid regurgitation [effective regurgitant orifice
(ERO)>20mm², or systolic hepatic vein flow blunting or reversal]
- Written signed informed consent
- Affiliation to the French health care system (Sécurité Sociale)
- Age < 18 years
- Severe organic renal dysfunction defined by creatinine clearance <30mL/min
- Recent endocarditis (<3 months)
- Recent myocardial infarction (<3 months)
- Tricuspid valve perforation or prolapse
- Cardiogenic shock requiring dobutamine support or cardiac assistance
- Severe liver injury (CHILD C)
- Left ventricular obstruction
- Allergy to levosimedan
- 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
- Pregnant or breastfeeding women
- Females of childbearing potential without effective method of birth control
- Patient on AME (state medical aid) unless exemption from affiliation
- Hypotension with SBP<90mmHg
- Severe tachycardia
- History of torsade de pointe