FranceLEVO - Zimino Registry (FZR) (FZR)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Heart Failure

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75015
      • Hôpital Européen Georges Pompidou, AP-HP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with cardiac dysfunction receiving levosimendan (Zimino®)

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Arcothova
• Investigators: Principal Investigator: Bernard CHOLLEY, MD, PhD, Arcothova

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): January 27, 2021
• Study Completion (Actual): May 6, 2021

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: cardiogenic shock; low cardiac output syndrome
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Arcothova

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The data will remain with the sponsor (Arcothova)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No