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

NCT05233202 | Unknown Phase 3 DMC

• 1 other identifier: APHP200072
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Evaluate the effects of CTAC on ventilation/perfusion ratios during a moderate to severe ARDS

  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.

  day 90

Secondary Outcomes (4)

• incidence of Refractory Hypotension (Drug safety)

  day 90

• Number of catecholamine infusion

  during 90 days

• Number of circulatory mechanical assist devices

  during 90 days

• Number of renal replacement therapy

  during 90 days

Study Arms (2)

LEVOSIMEDAN

EXPERIMENTAL

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.

Drug: Levosimendan

PLACEBO

PLACEBO COMPARATOR

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.

Drug: PLACEBO

Interventions

Levosimendan 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.

Also known as: Experimental arm

LEVOSIMEDAN

PLACEBO 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.

Also known as: Control arm

PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor

Créteil, 94000, France

RECRUITING

MeSH Terms

Interventions

Simendan

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Pascal LIM, MD, PhD

CONTACT

(0)1.49.81.45.84; pascal.lim@aphp.fr

Akim SOUAG

CONTACT

(0)1 44 84 17 15; akim.souag@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, randomized (two arms, parallel groups); double-blind, placebo-controlled study

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 10, 2022
• Study Start: January 23, 2023
• Primary Completion: January 23, 2025
• Study Completion: January 23, 2025
• Last Updated: May 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)