LevosimendanLevoCCVNCT05685537
Impact of Levosimendan Preconditioning on Critical Care and In-hospital Lengths of Stay After Cardiac Surgery With Bypass Surgery
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 to 99 years
- Conditions the study is for
- Levosimendan, Cardiac Surgery, Cardiopulmonary Bypass
- What is being tested?
- Levosimendan
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2022to 15 Feb 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 to 99 years
- 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 the CHRU de Nancy, CHRU de Rennes, CHRU de Rouen or CHRU d'Amiens.
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 the Nancy University Hospital or the University Hospital of Rennes, Rouen or Amiens
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.
- Conditions
- Levosimendan, Cardiac Surgery, Cardiopulmonary Bypass
- Being tested
- Levosimendan
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
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan - Interventional | 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 the Nancy University Hospital or at the University Hospital of Rennes, Rouen or Amiens, and who have received Levosimendan preoperatively Receives: Drug: Levosimendan | |
| Non Levosimendan - Control | 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 the Nancy University Hospital or at the University Hospital of Rennes, Rouen or Amiens, and who have not received Levosimendan preoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (7)
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
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
left ventricular systolic function 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 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
Measured: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
acute renal failure postoperatively
To evaluate the impact of preconditioning with Levosimendan preoperatively for cardiac surgery in patients with heart failure with impaired left ventricular function preoperatively on the rate of acute renal failure postoperatively
Measured: on discharge from the intensive care unit
readmission rate for cardiac decompensation
To evaluate the impact of preconditioning with Levosimendan preoperatively for cardiac surgery in patients with heart failure and impaired LVAS preoperatively on the readmission rate for cardiac decompensation
Measured: within one year of Levosimendan administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start15 Dec 2022
- Primary completion15 Dec 2022
- Study completion15 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- 120 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
- KLEIN Thomas, MD, Principal investigator, Intensive care unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685537
- Sponsor's protocol ID
- 2022_PI_118
- Acronym
- LevoCCV
- Status last verified
- Dec 2022
- First submitted
- 20 Dec 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erb J, Beutlhauser T, Feldheiser A, Schuster B, Treskatsch S, Grubitzsch H, Spies C. Influence of levosimendan on organ dysfunction in patients with severely reduced left ventricular function undergoing cardiac surgery. J Int Med Res. 2014 Jun;42(3):750-64. doi: 10.1177/0300060513516293. Epub 2014 Apr 29.
PubMed 24781725Sanfilippo F, Knight JB, Scolletta S, Santonocito C, Pastore F, Lorini FL, Tritapepe L, Morelli A, Arcadipane A. Levosimendan for patients with severely reduced left ventricular systolic function and/or low cardiac output syndrome undergoing cardiac surgery: a systematic review and meta-analysis. Crit Care. 2017 Oct 19;21(1):252. doi: 10.1186/s13054-017-1849-0.
PubMed 29047417van Diepen S, Mehta RH, Leimberger JD, Goodman SG, Fremes S, Jankowich R, Heringlake M, Anstrom KJ, Levy JH, Luber J, Nagpal AD, Duncan AE, Argenziano M, Toller W, Teoh K, Knight JD, Lopes RD, Cowper PA, Mark DB, Alexander JH. Levosimendan in patients with reduced left ventricular function undergoing isolated coronary or valve surgery. J Thorac Cardiovasc Surg. 2020 Jun;159(6):2302-2309.e6. doi: 10.1016/j.jtcvs.2019.06.020. Epub 2019 Jun 21.
PubMed 31358329Cholley B, Caruba T, Grosjean S, Amour J, Ouattara A, Villacorta J, Miguet B, Guinet P, Levy F, Squara P, Ait Hamou N, Carillion A, Boyer J, Boughenou MF, Rosier S, Robin E, Radutoiu M, Durand M, Guidon C, Desebbe O, Charles-Nelson A, Menasche P, Rozec B, Girard C, Fellahi JL, Pirracchio R, Chatellier G; -. Effect of Levosimendan on Low Cardiac Output Syndrome in Patients With Low Ejection Fraction Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass: The LICORN Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):548-556. doi: 10.1001/jama.2017.9973.
PubMed 28787507Levin R, Degrange M, Del Mazo C, Tanus E, Porcile R. Preoperative levosimendan decreases mortality and the development of low cardiac output in high-risk patients with severe left ventricular dysfunction undergoing coronary artery bypass grafting with cardiopulmonary bypass. Exp Clin Cardiol. 2012 Sep;17(3):125-30.
PubMed 23620700
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Levosimendan Preconditioning on Critical Care and In-hospital Lengths of Stay After Cardiac Surgery With Bypass Surgery
- ClinicalTrials.gov ID
- NCT05685537
- Acronym / sponsor ID
- LevoCCV / 2022_PI_118
- Conditions
- Levosimendan, Cardiac Surgery, Cardiopulmonary Bypass
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Feb 2023 (estimated)
- First posted
- 17 Jan 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 - Interventional | – | 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 the Nancy University Hospital or at the University Hospital of Rennes, Rouen or Amiens, and who have received Levosimendan preoperatively |
| Non Levosimendan - Control | – | –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 the Nancy University Hospital or at the University Hospital of Rennes, Rouen or Amiens, and who have not received Levosimendan preoperatively |
Who may qualify
- Ages
- 18 to 99 years
- 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 the CHRU de Nancy, CHRU de Rennes, CHRU de Rouen or CHRU d'Amiens.
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 the Nancy University Hospital or the University Hospital of Rennes, Rouen or Amiens
Key exclusion criteria (2 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 - Interventional |
Primary outcome
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
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.
7 secondary outcomes
On 1-year mortality
Time frame: 1 year after Levosimendan exposure
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
left ventricular systolic function 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
acute renal failure postoperatively
Time frame: on discharge from the intensive care unit
readmission rate for cardiac decompensation
Time frame: within one year of Levosimendan administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Background: PubMed 24781725Erb J, Beutlhauser T, Feldheiser A, Schuster B, Treskatsch S, Grubitzsch H, Spies C. Influence of levosimendan on organ dysfunction in patients with severely reduced left ventricular function undergoing cardiac surgery. J Int Med Res. 2014 Jun;42(3):750-64. doi: 10.1177/0300060513516293. Epub 2014 Apr 29.
- Background: PubMed 29047417Sanfilippo F, Knight JB, Scolletta S, Santonocito C, Pastore F, Lorini FL, Tritapepe L, Morelli A, Arcadipane A. Levosimendan for patients with severely reduced left ventricular systolic function and/or low cardiac output syndrome undergoing cardiac surgery: a systematic review and meta-analysis. Crit Care. 2017 Oct 19;21(1):252. doi: 10.1186/s13054-017-1849-0.
- Background: PubMed 31358329van Diepen S, Mehta RH, Leimberger JD, Goodman SG, Fremes S, Jankowich R, Heringlake M, Anstrom KJ, Levy JH, Luber J, Nagpal AD, Duncan AE, Argenziano M, Toller W, Teoh K, Knight JD, Lopes RD, Cowper PA, Mark DB, Alexander JH. Levosimendan in patients with reduced left ventricular function undergoing isolated coronary or valve surgery. J Thorac Cardiovasc Surg. 2020 Jun;159(6):2302-2309.e6. doi: 10.1016/j.jtcvs.2019.06.020. Epub 2019 Jun 21.
- Background: PubMed 28787507Cholley B, Caruba T, Grosjean S, Amour J, Ouattara A, Villacorta J, Miguet B, Guinet P, Levy F, Squara P, Ait Hamou N, Carillion A, Boyer J, Boughenou MF, Rosier S, Robin E, Radutoiu M, Durand M, Guidon C, Desebbe O, Charles-Nelson A, Menasche P, Rozec B, Girard C, Fellahi JL, Pirracchio R, Chatellier G; -. Effect of Levosimendan on Low Cardiac Output Syndrome in Patients With Low Ejection Fraction Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass: The LICORN Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):548-556. doi: 10.1001/jama.2017.9973.
- Results publication: PubMed 23620700Levin R, Degrange M, Del Mazo C, Tanus E, Porcile R. Preoperative levosimendan decreases mortality and the development of low cardiac output in high-risk patients with severe left ventricular dysfunction undergoing coronary artery bypass grafting with cardiopulmonary bypass. Exp Clin Cardiol. 2012 Sep;17(3):125-30.
- Individual participant dataSharing planned: No
Related trials for Levosimendan
Recruiting
The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
Enrolling by invitationPhase 3
Long-Term Open-Label Extension Study of Oral Levosimendan
Pulmonary Hypertension Associated With HFpEF
Active, not recruitingPhase 3
LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
Pulmonary Hypertension Associated With HFpEF
Active, not recruitingPhase 3
LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
Pulmonary Hypertension
RecruitingPhase 4
Shorter Weaning From Invasive Ventilation With Levosimendan
Mechanical Ventilation, Weaning Failure
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.
KLEIN Thomas, MD principal investigator
Intensive care unit
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 2 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 17 Jan 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 KLEIN THOMAS, MD (+33383154045, 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05685537, which also lists 5 linked publications.
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 17 Jan 2023.