FranceLEVO - Zimino Registry (FZR)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Heart Failure Cardiac Output, Low Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Européen Georges Pompidou, AP-HP

Paris, Île-de-France Region, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients receiving Zimino® treatment
Patients or patient's families not objecting to the patient's participation in the study.

Exclusion criteria

None

Treatment and study plan

Primary outcomes

Indication for levosimendan (Zimino)

Time frame: from January 28, 2020 until January 28, 2021
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)
Dose of levosimendan (Zimino) (in µg/kg/min)

Time frame: from January 28, 2020 until January 28, 2021

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)
Duration of levosimendan (Zimino) infusion

Time frame: from January 28, 2020 until January 28, 2021

Number of hours during which the patient received levosimendan

Sponsors and collaborators

Lead sponsor

Arcothova

Other

Registry information

Official study title

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

Acronym: FZR

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Feb 5, 2020
Registry last updated: Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed