An observational study in Acute Heart Failure, sponsored by Arcothova. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2021-07-21.
Sponsored by Arcothova · Observational
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 600 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with Arcothova as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients with cardiac dysfunction receiving levosimendan (Zimino®)
Exclusion Criteria:
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)
Time frame: 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)
Time frame: from January 28, 2020 until January 28, 2021
Duration of levosimendan (Zimino) infusion
Number of hours during which the patient received levosimendan
Time frame: from January 28, 2020 until January 28, 2021
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — The data will remain with the sponsor (Arcothova)
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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