LevosimendanLevoCVNCT06021587
Interest of Levosimendan Preconditioning for Cardiac Surgery Under CEC in Heart Failure Patients With Impaired Ejection Fraction
An observational study of Levosimendan and Cardiac Surgery, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Levosimendan, a drug with inotropic, vasodilatory and myocardial protective properties, has been proposed for the prevention and treatment of postoperative low cardiac output syndrome in cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Levosimendan, Cardiac Surgery, Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Levosimendan and No Levosimendan
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2023to 10 Oct 2023
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Preoperative heart failure patients with impaired LVEF who underwent left heart surgery (coronary artery bypass grafting and/or mitral and/or aortic valve replacement) under extracorporeal circulation from 01/09/2018 to 28/02/2022 at different University Hospital in France
Who may be able to join
- Patients with heart failure impaired LVEF (< 40%), who have undergone left heart surgery (coronary artery bypass grafting and/or mitral and/or aortic valve replacement) under extracorporeal circulation between 01/01/2018 and 28/02/2022 at different University Hospital in France
Who cannot join
- Initiation of levosimendan > 48 hours or < 24 hours before surgery ECMO pre- or post-op
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
'CHRU Nancy
Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54530
KLEIN Thomas, MD, +33383154045, t.klein@chru-nancy.fr
About this study
Levosimendan, a drug with inotropic, vasodilatory and myocardial protective properties, has been proposed for the prevention and treatment of postoperative low cardiac output syndrome in cardiac surgery. Despite preliminary studies with promising results, large randomized controlled trials aimed at demonstrating the benefits of levosimendan did not show superiority over placebo in this indication. However, in these studies, the infusion was neither performed at the maximum dosage nor during the 24 hours preceding the surgery, but mainly at the very beginning of the operation. However, post hoc analyses showed a reduction in mortality and in the occurrence of low cardiac output syndrome in the subgroup of patients who had undergone isolated coronary artery bypass grafting, in contrast to those who had undergone valvular or combined surgery. Another recent study suggests that under similar conditions, preconditioning with levosimendan started 48 hours before surgery reduces the length of stay in intensive care and the average cost of hospitalization. There are no formal recommendations on the prophylactic use of levosimendan in cardiac surgery for heart failure patients with impaired LVAS. However, the France-Levo registry, a multicenter observational study requested by the HAS, has shown that in real practice there is a place for preconditioning with levosimendan, which is used in this indication for 7% of the patients in the registry. The Cardiovascular Surgery and Transplantation Department of the Nancy Brabois University Hospital, which actively participated in the France-Levo registry, is one of the cardiac surgery centers that uses this practice, as is the University Hospital of Rouen. It is interesting to be able to evaluate retrospectively whether levosimendan preconditioning has a positive impact on the postoperative prognosis of patients and more particularly on the reduction of the length of stay in critical care and in hospital compared to standard management.
- Being tested
- Levosimendan, No Levosimendan
- Keywords
- Levosimendan, Cardiac Surgery, Cardiopulmonary Bypass, Heart Failure With Reduced Ejection Fraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
Also called Interventional
Initiation of levosimendan 48 hours before surgery
No LevosimendanDrug
Also called Control
Without Levosimendan Infusion
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan | Major patients in heart failure with impaired LVEF (< 40%) who have undergone left heart surgery (coronary artery bypass grafting and/or mitral and/or aortic valve replacement) under extracorporeal circulation between 01/01/2018 and 28/02/2022 at different French Hospital, and who have received Levosimendan preoperatively Receives: Drug: Levosimendan | |
| Control - No Levosimendan | Major patients in heart failure with impaired LVEF (< 40%) who have undergone left heart surgery (coronary artery bypass grafting and/or mitral and/or aortic valve replacement) under extracorporeal circulation between 01/01/2018 and 28/02/2022 at different French Hospital and who have not received Levosimendan preoperatively Receives: Drug: No Levosimendan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events (MACE) criteria at 30 days
to evaluate the impact of preconditioning with Levosimendan prior to scheduled cardiac surgery with extracorporeal circulation in patients with heart failure and impaired LVEF on the rate of cardiovascular events at 30 days post-op.
Measured: 30 days after Levosimendan exposure
Secondary outcomes (7)
major renal events (MAKE) at 30 days from the date of surgery
to evaluate the impact of preconditioning with Levosimendan prior to scheduled cardiac surgery under extracorporeal circulation in patients with heart failure and impaired LVEF on the rate of renal events at 30 days post cardiac surgery.
Measured: 30 days after Levosimendan exposure
On 1-year mortality
To evaluate the impact of preconditioning with Levosimendan before cardiac surgery in patients with heart failure and impaired left ventricular dysfunction on 1-year mortality
Measured: 1 year after Levosimendan exposure
Length of stay in ICU
To evaluate the impact of levosimendan preconditioning preoperatively for cardiac surgery on critical care length of stay in patients with heart failure with impaired preoperative LVAS
Measured: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
the total length of hospital stay
To evaluate the impact of preconditioning with Levosimendan preoperatively for cardiac surgery in patients with heart failure with impaired preoperative left ventricular dysfunction on the total length of hospital stay
Measured: start date of hospitalization in intensive care to the date of discharge from conventional sectors evaluated up to 3 months
Measurement of left ventricular ejection fraction by cardiac ultrasound at hospital discharge
To evaluate the impact of Levosimendan preconditioning before cardiac surgery in patients with heart failure and impaired on left ventricular systolic function (measured by cardiac ultrasound) at hospital discharge
Measured: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
duration of catecholamine use after surgery
To evaluate the impact of preconditioning with Levosimendan before cardiac surgery in patients with heart failure and impaired left ventricular function before surgery on the duration of catecholamine use after surgery
Measured: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
severity of postcardiotomy cardiogenic shock and/or postoperative vasoplegia using the score Vasoactive Inotropic Score (VIS)
To evaluate the impact of preconditioning with Levosimendan in preoperative cardiac surgery in patients with heart failure with impaired preoperative LVAS on the severity of postcardiotomy cardiogenic shock and/or postoperative vasoplegia. High VIS was empirically defined as ≥ 20. Maximum VIS≥20 predicts an increased likelihood of a poor composite clinical outcome
Measured: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 Jul 2023
- Primary completion2 Jul 2023
- Study completion10 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LevosimendanStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klein Thomas, Central Hospital, Nancy, France
- Investigators
- Thomas KLEIN, MD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021587
- Sponsor's protocol ID
- 2023_PI_084
- Acronym
- LevoCV
- Status last verified
- Aug 2023
- First submitted
- 26 Jul 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Levosimendan Preconditioning for Cardiac Surgery Under CEC in Heart Failure Patients With Impaired Ejection Fraction
- ClinicalTrials.gov ID
- NCT06021587
- Acronym / sponsor ID
- LevoCV / 2023_PI_084
- Keywords
- Levosimendan, Cardiac Surgery, Cardiopulmonary Bypass, Heart Failure With Reduced Ejection Fraction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 2 Jul 2023 (actual)
- Study completion
- 10 Oct 2023 (estimated)
- First posted
- 1 Sep 2023 (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.
Levosimendan, a drug with inotropic, vasodilatory and myocardial protective properties, has been proposed for the prevention and treatment of postoperative low cardiac output syndrome in cardiac surgery. Despite preliminary studies with promising results, large randomized controlled trials aimed at demonstrating the benefits of levosimendan did not show superiority over placebo in this indication. However, in these studies, the infusion was neither performed at the maximum dosage nor during the 24 hours preceding the surgery, but mainly at the very beginning of the operation. However, post hoc analyses showed a reduction in mortality and in the occurrence of low cardiac output syndrome in the subgroup of patients who had undergone isolated coronary artery bypass grafting, in contrast to those who had undergone valvular or combined surgery. Another recent study suggests that under similar conditions, preconditioning with levosimendan started 48 hours before surgery reduces the length of stay in intensive care and the average cost of hospitalization. There are no formal recommendations on the prophylactic use of levosimendan in cardiac surgery for heart failure patients with impaired LVAS. However, the France-Levo registry, a multicenter observational study requested by the HAS, has shown that in real practice there is a place for preconditioning with levosimendan, which is used in this indication for 7% of the patients in the registry. The Cardiovascular Surgery and Transplantation Department of the Nancy Brabois University Hospital, which actively participated in the France-Levo registry, is one of the cardiac surgery centers that uses this practice, as is the University Hospital of Rouen. It is interesting to be able to evaluate retrospectively whether levosimendan preconditioning has a positive impact on the postoperative prognosis of patients and more particularly on the reduction of the length of stay in critical care and in hospital compared to standard management.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levosimendan | – | Drug: LevosimendanMajor patients in heart failure with impaired LVEF (< 40%) who have undergone left heart surgery (coronary artery bypass grafting and/or mitral and/or aortic valve replacement) under extracorporeal circulation between 01/01/2018 and 28/02/2022 at different French Hospital, and who have received Levosimendan preoperatively |
| Control - No Levosimendan | – | Drug: No LevosimendanMajor patients in heart failure with impaired LVEF (< 40%) who have undergone left heart surgery (coronary artery bypass grafting and/or mitral and/or aortic valve replacement) under extracorporeal circulation between 01/01/2018 and 28/02/2022 at different French Hospital and who have not received Levosimendan preoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Preoperative heart failure patients with impaired LVEF who underwent left heart surgery (coronary artery bypass grafting and/or mitral and/or aortic valve replacement) under extracorporeal circulation from 01/09/2018 to 28/02/2022 at different University Hospital in France
Key inclusion criteria (1 listed)
- Patients with heart failure impaired LVEF (< 40%), who have undergone left heart surgery (coronary artery bypass grafting and/or mitral and/or aortic valve replacement) under extracorporeal circulation between 01/01/2018 and 28/02/2022 at different University Hospital in France
Key exclusion criteria (1 listed)
- Initiation of levosimendan > 48 hours or < 24 hours before surgery ECMO pre- or post-op
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevosimendanAlso: InterventionalInitiation of levosimendan 48 hours before surgery | Drug | Levosimendan |
| No LevosimendanAlso: ControlWithout Levosimendan Infusion | Drug | Control - No Levosimendan |
Primary outcome
Major Adverse Cardiac Events (MACE) criteria at 30 days
Time frame: 30 days after Levosimendan exposure
to evaluate the impact of preconditioning with Levosimendan prior to scheduled cardiac surgery with extracorporeal circulation in patients with heart failure and impaired LVEF on the rate of cardiovascular events at 30 days post-op.
7 secondary outcomes
major renal events (MAKE) at 30 days from the date of surgery
Time frame: 30 days after Levosimendan exposure
On 1-year mortality
Time frame: 1 year after Levosimendan exposure
Length of stay in ICU
Time frame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
the total length of hospital stay
Time frame: start date of hospitalization in intensive care to the date of discharge from conventional sectors evaluated up to 3 months
Measurement of left ventricular ejection fraction by cardiac ultrasound at hospital discharge
Time frame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
duration of catecholamine use after surgery
Time frame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
severity of postcardiotomy cardiogenic shock and/or postoperative vasoplegia using the score Vasoactive Inotropic Score (VIS)
Time frame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Long-Term Open-Label Extension Study of Oral Levosimendan
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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.
Thomas KLEIN, MD principal investigator
Central Hospital, Nancy, France
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 Levosimendan and Cardiac Surgery, run by Central Hospital, Nancy, France 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 1 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: status not confirmed, as of the sponsor's last update on 1 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas KLEIN, MD (+3383154045, t.klein@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (MACE) criteria at 30 days (time frame: 30 days after Levosimendan exposure). 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 1 Sep 2023.