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Interest of Levosimendan in Reducing Weaning Failures of ExtraCorporeal Life Support - ECLS (Weanilevo)

Primary Purpose

Acute Decompensated Heart Failure

Status

Recruiting

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Levosimendan

Cernevit

About this trial

This is an interventional treatment trial for Acute Decompensated Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

adult patient
patient or person responsible for the patient has given written consent
patient with acute circulatory heart failure under ECLS
patient meeting criteria for ECLS withdrawal
- ECLS flow rate at 1.0-1.5l/min and/or ECLS pump rpm ≤ 1500 rpm
- LVEF > 20% in cardiac ultrasound and aortic ITV > 10 cm
- VIS score ≤ 10
- Arterial lactates ≤ 2 mmol/l
- Right ventricular outflow tract shortening fraction > 30%
- Basal diameter at the tricuspid telediastolic ring of the right ventricle < 35 mm
- Fraction of inspired oxygen combined between ventilator and ECLS < 80%
ECLS withdrawl scheduled within 48 hours
Absence of an initial or progressive infectious episode (no planned introduction of antibiotic therapy within 48 hours prior to inclusion)

Exclusion Criteria:

Patient with hepatic insufficiency: cytolysis at least 20 times normal
Drug intoxication and attempted suicide
Patient with a contraindication to the use of levosimendan:
- hypersensitivity to the active substance or any of the excipients
- severe hypotension and ventricular tachycardia
- significant mechanical obstructions affecting ventricular filling and/or ejection
- severe renal failure (creatinine clearance < 30 ml/min)
- severe liver failure (TP<50%)
- history of torsades de pointes
Patient with a contraindication to the use of CERNEVIT®:
- hypersensitivity to active substances, in particular to vitamin B1 or to one of the excipients or to soy protein products or to peanut protein products
- hypervitaminosis to any vitamin contained in this formulation
- severe hypercalcemia, hyper calciuria, tumour, bone metastasis, primary hyperparathyroidism, granulomatosis
patient not affiliated to or not benefiting from national health insurance
patient subject to legal protection (curatorship, guardianship)
patient subject to limited judicial protection
pregnant, parturient or breastfeeding woman

Sites / Locations

CHU Dijon BourgogneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Levosimendan

Placebo

Arm Description

Outcomes

Primary Outcome Measures

ECLS withdrawal failure

Withdrawal failure is defined as the absence of ECLS discontinuation within 48 hours of randomization or the use of temporary circulatory assistance such as ECLS, Impella® pump or intra-aortic balloon pump (IABP) or death

Secondary Outcome Measures

Full Information

NCT ID

NCT04158674

First Posted

November 7, 2019

Last Updated

April 27, 2021

Sponsor

Centre Hospitalier Universitaire Dijon

1. Study Identification

Unique Protocol Identification Number

NCT04158674

Brief Title

Interest of Levosimendan in Reducing Weaning Failures of ExtraCorporeal Life Support - ECLS

Acronym

Weanilevo

Official Title

Interest of Levosimendan in Reducing Weaning Failures of ExtraCorporeal Life Support - ECLS. Randomized, Controlled, Multicenter, Double-blind, Multicenter Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Recruiting

Study Start Date

February 24, 2020 (Actual)

Primary Completion Date

February 2023 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Extracorporeal life support (ECLS) is a circulatory cardio supplementation technique; it therefore makes it possible to compensate for a defective cardiac or cardio-respiratory function. ECLS nevertheless remains a temporary assistance technique pending a potential recovery of cardiac function, or it can be used to direct patients towards a heart transplant or long-term circulatory assistance (Left Ventricular Assist Device (LVAD) or Total Heart). In patients with complete or partial recovery of cardiac and circulatory function, ECLS withdrawal may be considered. Withdrawal from ECLS remains a delicate phase and the risk of failure is high. The mechanism of action of levosimendan, a drug that increases the contractility of the heart, suggests that it would improve the heart-vessel connection and reduce the rate of ECLS withdrawal failure. The effect of levosimendan is maximal 24 to 48 hours after the end of the infusion and has a prolonged period of action. The objective is to evaluate the efficacy of levosimendan administration (0.2 µg/kg/min over 24 hours) - versus placebo - prior to ECLS removal on the rate of withdrawal failure in patients under ECLS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Decompensated Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Levosimendan

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Sham Comparator

Intervention Type

Drug

Intervention Name(s)

Levosimendan

Intervention Description

Levosimendan 2.5mg/ml, solution to be diluted for infusion Dilution in a 500ml bag of 5% Glucose The product is administered as a continuous infusion for 24 hours at an initial rate of 0.2 µg/kg/min

Intervention Type

Drug

Intervention Name(s)

Cernevit

Intervention Description

mixture of 12 vitamins The dilution of the treatment is done in a 500ml bag of 5% Glucose The product is administered as a continuous infusion for 24 hours at an initial rate of 0.2 µg/kg/min

Primary Outcome Measure Information:

Title

ECLS withdrawal failure

Description

Time Frame

7 days after ECLS removal

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: adult patient patient or person responsible for the patient has given written consent patient with acute circulatory heart failure under ECLS patient meeting criteria for ECLS withdrawal ECLS flow rate at 1.0-1.5l/min and/or ECLS pump rpm ≤ 1500 rpm LVEF > 20% in cardiac ultrasound and aortic ITV > 10 cm VIS score ≤ 10 Arterial lactates ≤ 2 mmol/l Right ventricular outflow tract shortening fraction > 30% Basal diameter at the tricuspid telediastolic ring of the right ventricle < 35 mm Fraction of inspired oxygen combined between ventilator and ECLS < 80% ECLS withdrawl scheduled within 48 hours Absence of an initial or progressive infectious episode (no planned introduction of antibiotic therapy within 48 hours prior to inclusion) Exclusion Criteria: Patient with hepatic insufficiency: cytolysis at least 20 times normal Drug intoxication and attempted suicide Patient with a contraindication to the use of levosimendan: hypersensitivity to the active substance or any of the excipients severe hypotension and ventricular tachycardia significant mechanical obstructions affecting ventricular filling and/or ejection severe renal failure (creatinine clearance < 30 ml/min) severe liver failure (TP<50%) history of torsades de pointes Patient with a contraindication to the use of CERNEVIT®: hypersensitivity to active substances, in particular to vitamin B1 or to one of the excipients or to soy protein products or to peanut protein products hypervitaminosis to any vitamin contained in this formulation severe hypercalcemia, hyper calciuria, tumour, bone metastasis, primary hyperparathyroidism, granulomatosis patient not affiliated to or not benefiting from national health insurance patient subject to legal protection (curatorship, guardianship) patient subject to limited judicial protection pregnant, parturient or breastfeeding woman

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed Omar ELLOUZE

Phone

03.80.29.32.62

Ext

+33

mohamedomar.ellouze@chu-dijon.fr

Facility Information:

Facility Name

CHU Dijon Bourgogne

City

Dijon

ZIP/Postal Code

21079

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohamed Omar ELLOUZE

Phone

03 80 29 32 62

Ext

+33

mohamedomar.ellouze@chu-dijon.fr

12. IPD Sharing Statement

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Interest of Levosimendan in Reducing Weaning Failures of ExtraCorporeal Life Support - ECLS

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