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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Indication for levosimendan (Zimino) | Physicians will be requested to choose one of the following indications (pop-up list):
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with cardiac dysfunction receiving levosimendan (Zimino®)
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| Name | Affiliation | Role |
|---|---|---|
| Bernard CHOLLEY, MD, PhD | Arcothova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Européen Georges Pompidou, AP-HP | Paris | Île-de-France Region | 75015 | France |
The data will remain with the sponsor (Arcothova)
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 8, 2019 | Jan 15, 2020 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 8, 2019 | Jan 29, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002303 | Cardiac Output, Low |
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
| D012769 | Shock |