Levosimendan Versus Placebo Before Tricuspid Valve Surgery in Patients With Right Ventricular Dysfunction

NCT ID: NCT05233202

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-23
• Study Completion Date: 2025-01-23

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 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.

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 experimental group, levosimendan is administered as a continuous infusion over a 24-hour period at the rate of 0.2μg/kg/min, with no bolus administration. The infusion will begin 24H to 48H before anesthetic induction.

In the comparator group, Placebo (isotonic sodium) administered as a continuous infusion over a 24-hour period at the rate of 0.2μg/kg/min, with no bolus administration. The infusion will begin <48H before anesthetic induction

Conditions

Patients Referred for an Isolated or a Combined Surgical Correction of Functional Moderate to Severe Tricuspid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

LEVOSIMEDAN

Levosimendan administered as a continuous infusion over a 24-hour period at the rate of 0.2μg/kg/min, with no bolus administration. The infusion will begin 24H to 48H before anesthetic induction.

Group Type: EXPERIMENTAL

Levosimendan

Intervention Type: DRUG

Levosimendan administered as a continuous infusion over a 24-hour period at the rate of 0.2μg/kg/min, with no bolus administration. The infusion will begin 24H to 48H before anesthetic induction.

PLACEBO

Placebo (isotonic sodium) administered as a continuous infusion over a 24-hour period at the rate of 0.2μg/kg/min, with no bolus administration. The infusion will begin \<48H before anesthetic induction.

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DRUG

Placebo (isotonic sodium) administered as a continuous infusion over a 24-hour period at the rate of 0.2μg/kg/min, with no bolus administration. The infusion will begin \<48H before anesthetic induction.

Interventions

Levosimendan

Levosimendan administered as a continuous infusion over a 24-hour period at the rate of 0.2μg/kg/min, with no bolus administration. The infusion will begin 24H to 48H before anesthetic induction.

Intervention Type: DRUG

PLACEBO

Placebo (isotonic sodium) administered as a continuous infusion over a 24-hour period at the rate of 0.2μg/kg/min, with no bolus administration. The infusion will begin \<48H before anesthetic induction.

Intervention Type: DRUG

Other Intervention Names

Experimental arm; Control arm

Eligibility 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)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor

Créteil, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Pascal LIM, MD, PhD

Role: CONTACT

pascal.lim@aphp.fr

(0)1.49.81.45.84 ext. 33

Akim SOUAG

Role: CONTACT

akim.souag@aphp.fr

(0)1 44 84 17 15 ext. 33

Facility Contacts

Pascal LIM, Pr

Role: primary

lim.pascal.hmn@gmail.com

0033-149812111 ext. 33

Other Identifiers

APHP200072

Identifier Type: -

Identifier Source: org_study_id