Status:
UNKNOWN
Levosimendan Versus Placebo Before Tricuspid Valve Surgery in Patients With Right Ventricular Dysfunction
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Patients Referred for an Isolated or a Combined Surgical Correction of Functional Moderate to Severe Tricuspid
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 o...
Detailed Description
Patients referred for an isolated or a combined surgical correction of functional moderate to severe tricuspid are randomized in 2 arms, the levosimendan group or to the placebo group. In the experim...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
January 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 23 2025
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT05233202
Start Date
January 23 2023
End Date
January 23 2025
Last Update
May 15 2023
Active Locations (1)
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1
Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor
Créteil, France, 94000