LEvOsimendaN vs. Placebo Before Tricuspid VAlve Surgery in Patients with Right Ventricular Dysfunction

LEvOsimendaN vs. Placebo Before Tricuspid VAlve Surgery in Patients with Right Ventricular Dysfunction - LEONARD

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005600-19-FR

Enrollment

230

Registered

2021-05-17

Start date

2022-06-17

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 21.1 Level: LLT Classification code 10068176 Term: Coronary artery bypass graft System Organ Class: 100000004865

Interventions

Trade Name: ZIMINO 12,5 mg Product Name: ZIMINO Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: LEVOSIMENDAN CAS Number: 141505-33-1 Concentration unit: mg/l milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: The secondary end points were 1) each component of the primary end point, and 2) the study drug safety defined as refractory hypotension. ;Primary end point(s): The primary end point is a composite element reflecting low cardiac output syndrome: -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. If a patient had at least 1 of these criteria, he or she was considered as meeting the primary end point. The primary end-point is defined as event occurring during the post-operative hospitalization period in intensive care unit. This period is usually limited at 90 days.	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: The secondary end points were 1) each component of the primary end point, and 2) the study drug safety defined as refractory hypotension. ;Primary end point(s): The primary end point is a composite element reflecting low cardiac output syndrome: -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. If a patient had at least 1 of these criteria, he or she was considered as meeting the primary end point. The primary end-point is defined as event occurring during the post-operative hospitalization period in intensive care unit. This period is usually limited at 90 days.

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Secondary

Measure	Time frame
Secondary end point(s): The secondary end points were: - Mortality at day 90, - Each component of the primary end point, - 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.	—

Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026