FranceLEVO - Zimino Registry (FZR)

Completed

• Conditions: Acute Heart Failure

• Registration Number: NCT04252404
• Lead Sponsor: Arcothova

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-31
• Study Start: 2020-02-03
• Study First Posted: 2020-02-05
• Primary Completion: 2021-01-27
• Study Completion: 2021-05-06
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Indication for levosimendan (Zimino)	from January 28, 2020 until January 28, 2021	Physicians will be requested to choose one of the following indications (pop-up list): 1. Cardiogenic shock (medical setting or post cardiac surgery); 2. Heart failure decompensation (medical, setting); 3. Low cardiac output syndrome (post cardiac surgery); 4. Heart failure decompensation in a patient receiving beta-blockers; 5. ECMO weaning; 6. Repetitive use in a patient with end-stage heart failure; 7. Other (text)
Dose of levosimendan (Zimino) (in µg/kg/min)	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	from January 28, 2020 until January 28, 2021	Number of hours during which the patient received levosimendan

Trial Locations

Locations (1)

Hôpital Européen Georges Pompidou, AP-HP; 🇫🇷 Paris, Ile De France, France