Using Levosimendan to Improve Outcomes in Heart Surgery for Patients with Heart Failure
Interest of Levosimendan Preconditioning for Cardiac Surgery Under CEC in Heart Failure Patients With Impaired Ejection Fraction
This study is testing if giving levosimendan to heart failure patients before heart surgery can help them recover better and avoid complications after the operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 1 site (Vandœuvre-lès-Nancy, Meurthe Et Moselle) |
| Trial ID | NCT06021587 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of levosimendan preconditioning in patients with heart failure and reduced ejection fraction undergoing cardiac surgery with cardiopulmonary bypass. The study aims to assess whether administering levosimendan 48 hours prior to surgery can reduce the incidence of postoperative low cardiac output syndrome and improve overall outcomes. It focuses on patients who have undergone specific heart surgeries, including coronary artery bypass grafting and valve replacements, at a university hospital in France. The study will analyze data from patients treated between January 2018 and February 2022.
Who should consider this trial
Good fit: Ideal candidates are patients with heart failure and an impaired left ventricular ejection fraction of less than 40% who are scheduled for specific heart surgeries.
Not a fit: Patients who have not received levosimendan within the specified time frame or those undergoing ECMO pre- or post-operatively may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved postoperative outcomes and reduced mortality for heart failure patients undergoing cardiac surgery.
How similar studies have performed: Previous studies have shown mixed results with levosimendan, but some analyses suggest potential benefits in specific patient subgroups, indicating that this approach may hold promise.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vandœuvre-lès-Nancy, Meurthe Et Moselle
- 'CHRU Nancy — Vandœuvre-lès-Nancy, Meurthe Et Moselle, France (Recruiting)
Study contacts
- Principal investigator: Thomas KLEIN, MD — Central Hospital, Nancy, France
- Study coordinator: Thomas KLEIN, MD
- Email: t.klein@chru-nancy.fr
- Phone: +3383154045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.