FranceLEVO - Zimino Registry (FZR)

NCT04252404 | Completed DMC

• 1 other identifier: Arcothova
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Heart Failure

Keywords

low cardiac output syndrome; cardiogenic shock

Outcome Measures

Primary Outcomes (3)

• Indication for levosimendan (Zimino)

  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)

  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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with cardiac dysfunction receiving levosimendan (Zimino®)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Arcothova: lead

Study Sites (1)

Hôpital Européen Georges Pompidou, AP-HP

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

Location

MeSH Terms

Conditions

Cardiac Output, Low; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Shock

Study Officials

• Bernard CHOLLEY, MD, PhD

  Arcothova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: February 5, 2020
• Study Start: February 3, 2020
• Primary Completion: January 27, 2021
• Study Completion: May 6, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)