FranceLEVO - Zimino Registry (FZR)

Study Overview
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Brief Summary
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The French National Authority for Health (Haute Autorité de santé) requested a registry study to obtain post-market surveillance data to describe baseline clinical profiles, management and outcome of patients treated with Zimino®. This study is designed to provide real-life data on the use, safety and clinical outcomes of Zimino® in routine clinical practice in France.

Detailed Description
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This is a real-life, non-interventional, observational, multicentre study in all patients (including children) receiving Zimino® in France. The patients will be evaluated during the index hospitalisation and on follow-up days 30 (±15) and 90 (±15) after hospital discharge. The follow-up can be a phone call or a visit to the hospital. Patients who meet the eligibility criteria will be identified consecutively at each hospital. The participating hospitals will vary in size and medical activities, depending on their location and the population size they serve. The physician will determine the patient's treatment strategy. Drug prescriptions and the indications to perform diagnostic or therapeutic procedures will be left completely to the discretion of the physicians. The estimated enrollment period is 12 months (enrollment of the first patient - enrollment of the last patient), or less if the cohort (n=600) is completed earlier, and the maximum total data collection period is 15 months.

Official Title
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FranceLEVO - Zimino® Registry: a French Registry Evaluating the Use of Levosimendan (Zimino®)

Conditions
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Acute Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving Zimino® treatment Patients or patient's families not objecting to the patient's participation in the study. Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indication for levosimendan (Zimino) | Physicians will be requested to choose one of the following indications (pop-up list): Cardiogenic shock (medical setting or post cardiac surgery) Heart failure decompensation (medical, setting) Low cardiac output syndrome (post cardiac surgery) Heart failure decompensation in a patient receiving beta-blockers ECMO weaning Repetitive use in a patient with end-stage heart failure Other (text) | from January 28, 2020 until January 28, 2021 | 
| Dose of levosimendan (Zimino) (in µg/kg/min) | Physicians will be requested to describe the levosimendan regimen used: A) Loading dose (in µg/kg) B) Dose of the continuous infusion (in µg/kg/min) | from January 28, 2020 until January 28, 2021 | 
| Duration of levosimendan (Zimino) infusion | Number of hours during which the patient received levosimendan | from January 28, 2020 until January 28, 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low cardiac output syndrome, cardiogenic shock