EvOsimendaN vs. Placebo Before Tricuspid VAlve Surgery in Patients with Right Ventricular Dysfunctio

Phase 1

• Conditions: MedDRA version: 21.1Level: LLTClassification code 10068176Term: Coronary artery bypass graftSystem Organ Class: 100000004865

• Registration Number: EUCTR2020-005600-19-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-17
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 230

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified