Interest of Levosimendan Preconditioning for Cardiac Surgery Under CEC in Heart Failure Patients With Impaired Ejection Fraction

NCT ID: NCT06021587

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2023-10-10

Brief 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. 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; Heart Failure With Reduced Ejection Fraction

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Levosimendan

Intervention Type: DRUG

Initiation of levosimendan 48 hours before surgery

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

No Levosimendan

Intervention Type: DRUG

Without Levosimendan Infusion

Interventions

Levosimendan

Initiation of levosimendan 48 hours before surgery

Intervention Type: DRUG

No Levosimendan

Without Levosimendan Infusion

Intervention Type: DRUG

Other Intervention Names

Interventional; Control

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Initiation of levosimendan > 48 hours or < 24 hours before surgery ECMO pre- or post-op

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Klein Thomas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas KLEIN, MD

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Locations

'CHRU Nancy

Vandœuvre-lès-Nancy, Meurthe Et Moselle, France

Site Status: RECRUITING

Countries

France

Central Contacts

Thomas KLEIN, MD

Role: CONTACT

t.klein@chru-nancy.fr

+3383154045

Thomas KLEIN, MD

Role: CONTACT

t.klein@chru-nancy.fr

++33154045

Facility Contacts

KLEIN Thomas, MD

Role: primary

t.klein@chru-nancy.fr

+33383154045

Other Identifiers

2023_PI_084

Identifier Type: -

Identifier Source: org_study_id