Acute Heart FailureFZRNCT04252404
FranceLEVO - Zimino Registry (FZR)
An observational study of Acute Heart Failure, run by Arcothova at 1 site in France.
Trial 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®. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Heart Failure
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2020to 6 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cardiac dysfunction receiving levosimendan (Zimino®)
Who may be able to join
- Patients receiving Zimino® treatment
- Patients or patient's families not objecting to the patient's participation in the study.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Européen Georges Pompidou, AP-HP
Paris, Île-de-France Region, 75015
About this study
Official title: FranceLEVO - Zimino® Registry: a French Registry Evaluating the Use of Levosimendan (Zimino®)
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.
Read the 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.
- Conditions
- Acute Heart Failure
- Keywords
- low cardiac output syndrome, cardiogenic shock
- Medical subject headings
- Cardiac Output, Low, Shock, Cardiogenic
What is being measured
The primary outcome is the main question the study is designed to answer.
Indication for levosimendan (Zimino)
Physicians will be requested to choose one of the following indications (pop-up list):
- Cardiogenic shock (medical setting or post cardiac surgery)
- Heart failure decompensation (medical, setting)
- Low cardiac output syndrome (post cardiac surgery)
- Heart failure decompensation in a patient receiving beta-blockers
- ECMO weaning
- Repetitive use in a patient with end-stage heart failure
- Other (text)
Measured: 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:
- Loading dose (in µg/kg) B) Dose of the continuous infusion (in µg/kg/min)
Measured: from January 28, 2020 until January 28, 2021
Duration of levosimendan (Zimino) infusion
Number of hours during which the patient received levosimendan
Measured: from January 28, 2020 until January 28, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start3 Feb 2020
- Primary completion27 Jan 2021
- Study completion6 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcothova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cholley Bernard, Arcothova
- Investigators
- Bernard CHOLLEY, MD, PhD, Principal investigator, Arcothova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252404
- Sponsor's protocol ID
- Arcothova
- Acronym
- FZR
- Status last verified
- Jul 2021
- First submitted
- 15 Jan 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will remain with the sponsor (Arcothova)
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FranceLEVO - Zimino® Registry: a French Registry Evaluating the Use of Levosimendan (Zimino®)
- ClinicalTrials.gov ID
- NCT04252404
- Acronym / sponsor ID
- FZR / Arcothova
- Conditions
- Acute Heart Failure
- Keywords
- low cardiac output syndrome, cardiogenic shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- ArcothovaUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cardiac dysfunction receiving levosimendan (Zimino®)
Key inclusion criteria (2 listed)
- Patients receiving Zimino® treatment
- Patients or patient's families not objecting to the patient's participation in the study.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: No. The data will remain with the sponsor (Arcothova)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard CHOLLEY, MD, PhD principal investigator
Arcothova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure, run by Arcothova at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indication for levosimendan (Zimino) (time frame: from January 28, 2020 until January 28, 2021). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.