Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-30 @ 4:58 PM
Study NCT ID:
NCT04252404
Status:
COMPLETED
Last Update Posted:
2021-07-21
First Post:
2020-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FranceLEVO - Zimino Registry (FZR)
Sponsor:
Arcothova
Organization:
Study Overview
Official Title:
FranceLEVO - Zimino® Registry: a French Registry Evaluating the Use of Levosimendan (Zimino®)
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FZR
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: