NCT04252404

FranceLEVO - Zimino Registry (FZR)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 600 (actual)
• Sponsor: Arcothova · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Heart Failure

Timeline

• Start date: 2020-02-03
• Primary completion: 2021-01-27
• Completion: 2021-05-06
• First posted: 2020-02-05
• Last updated: 2021-07-21

Locations

1 site across 1 country: France