FranceLEVO - Zimino® Registry: a French Registry Evaluating the Use of Levosimendan (Zimino®)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Indication for levosimendan (Zimino)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving Zimino® treatment
- •Patients or patient's families not objecting to the patient's participation in the study.
排除标准
- 未提供
结局指标
主要结局
Indication for levosimendan (Zimino)
时间窗: 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)
时间窗: 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
时间窗: from January 28, 2020 until January 28, 2021
Number of hours during which the patient received levosimendan
次要结局
未报告次要终点
研究者
Cholley Bernard
Coordinating Investigator
Arcothova