Last reviewed · How we verify
NCT06021587: LevoCV
Interest of Levosimendan Preconditioning for Cardiac Surgery Under CEC in Heart Failure Patients With Impaired Ejection Fraction
trial testing Levosimendan in Levosimendan in 300 participants. Status unknown.
2 July 2023
Quick facts
| Lead sponsor | Central Hospital, Nancy, France |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 1 July 2023 |
| Primary completion | 2 July 2023 |
| Estimated completion | 10 October 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- Levosimendan (LEVOSIMENDAN) — full drug profile →
- No Levosimendan — full drug profile →
Conditions studied
- Levosimendan — all drugs for Levosimendan →
- Cardiac Surgery — all drugs for Cardiac Surgery →
- Heart Failure With Reduced Ejection Fraction — all drugs for Heart Failure With Reduced Ejection Fraction →
Sponsor
Central Hospital, Nancy, France
Who can join
18 and older, any sex, with Levosimendan or Cardiac Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06021587
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Levosimendan
Trials testing the same drug.
- NCT07262723 — Levosimendan in Acute Decompensated Heart Failure · Phase 2, PHASE3 · not yet recruiting
- NCT05664191 — Levosimendan as Treatment of Aneurysmal SubArachnoid Haemorrhage · Phase 2 · recruiting
- NCT05730907 — Efficacy and Clinical Outcomes of Levosimendan in E-CPR · unknown
- NCT05233202 — Levosimendan Versus Placebo Before Tricuspid Valve Surgery in Patients With Right Ventricular Dysfunction · Phase 3 · unknown
- NCT05685537 — Impact of Levosimendan Preconditioning on Critical Care and In-hospital Lengths of Stay After Cardiac Surgery With Bypas · unknown
Other Central Hospital, Nancy, France trials
Trials by the same sponsor.
- NCT06452290 — PET Biomarker Study for Antidepressant Response Prediction in Major Depressive Disorder · NA · not yet recruiting
- NCT07518498 — Hypnosis During Mechanical Ventilation Weaning · NA · not yet recruiting
- NCT07471334 — Prospective Study of Postictal Psychotic Symptoms Occuring After Video-EEG Monitoring in Focal Epilepsies · NA · not yet recruiting
- NCT07414667 — Primary Sjögren's Syndrome: Impact of Quantitative Anti-Ro52 Antibody Analysis on Patient Prognosis and Stratification ( · not yet recruiting
- NCT07415759 — Imaging of Electrical Properties by MRI: Investigation of Age-Related Changes · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06021587 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Central Hospital, Nancy, France
- Last refreshed: 1 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06021587.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing