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

NCT06021587 | Unknown

• 1 other identifier: 2023_PI_084
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

Levosimendan; Cardiac Surgery; Cardiopulmonary Bypass; Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days after Levosimendan exposure

Secondary Outcomes (7)

• major renal events (MAKE) at 30 days from the date of surgery

  30 days after Levosimendan exposure

• On 1-year mortality

  1 year after Levosimendan exposure

• Length of stay in ICU

  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

  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

  date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months

Study Arms (2)

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

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

Drug: No Levosimendan

Interventions

Levosimendan DRUG

Initiation of levosimendan 48 hours before surgery

Also known as: Interventional

Levosimendan

No Levosimendan DRUG

Without Levosimendan Infusion

Also known as: Control

Control - No Levosimendan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

'CHRU Nancy

Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54530, France

RECRUITING

MeSH Terms

Interventions

Simendan; Methods

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Investigative Techniques

Study Officials

• Thomas KLEIN, MD

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas KLEIN, MD

CONTACT

+3383154045; t.klein@chru-nancy.fr

Thomas KLEIN, MD

CONTACT

++33154045; t.klein@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: September 1, 2023
• Study Start: July 1, 2023
• Primary Completion: July 2, 2023
• Study Completion: October 10, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

FR (1)