FranceLEVO - Zimino® Registry: a French Registry Evaluating the Use of Levosimendan (Zimino®)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Heart Failure
- Sponsor
- Arcothova
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Indication for levosimendan (Zimino)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Cholley Bernard
Coordinating Investigator
Arcothova
Eligibility Criteria
Inclusion Criteria
- •Patients receiving Zimino® treatment
- •Patients or patient's families not objecting to the patient's participation in the study.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Indication for levosimendan (Zimino)
Time Frame: 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)
Time Frame: 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
Time Frame: from January 28, 2020 until January 28, 2021
Number of hours during which the patient received levosimendan