FranceLEVO - Zimino Registry (FZR)

Acute Heart Failure Clinical Trial

— FZR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04252404
• Other study ID #: Arcothova
• Status: Completed
• Start date: February 3, 2020
• Est. completion date: May 6, 2021

Study information

• Verified date: July 2021
• Source: Arcothova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: May 6, 2021
• Est. primary completion date: January 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients receiving Zimino® treatment

• Patients or patient's families not objecting to the patient's participation in the study.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Locations

Country	Name	City	State
France	Hôpital Européen Georges Pompidou, AP-HP	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Arcothova

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Duration of levosimendan (Zimino) infusion	Number of hours during which the patient received levosimendan	from January 28, 2020 until January 28, 2021