Levosimendan In Patients Undergoing LVAD Implantation

• Conditions: Biventricular Failure; Left Ventricular Dysfunction; Right Ventricular Dysfunction
• Interventions: Drug: Levosimendan 2.5 MG/ML Injectable Solution

• Registration Number: NCT03659851
• Lead Sponsor: University Hospital Dubrava

Brief Summary

According to the results from the literature, it has been shown that levosimendan usage 24-48 hours before LVAD implementation can improve short and long-term outcome in these patients regarding to the patients without preoperative pretreatment. The aim is to compare short and long-term outcome in patients who underwent to LVAD implementation and pretreated with levosimendan regarding the patient without pretreatment or with other medications.

Detailed Description

Left ventricular assist device (LVAD) implantation is accepted for treatment of end-stage heart failure, in both as the bridging to heart transplantation or as the destination therapy. These patients have highly impaired systolic function which contributes to global heart dysfunction. The main complication is arising of pulmonary vascular pressures and pulmonary vascular resistance (PVR) and, consequently, right heart dysfunction. From the data in literature, RV dysfunction exist in approximately 25%-40% of patients with implanted LVAD, and in approximately 20%-30% of those died or have need for the RV assist device due to RV failure refractory to medications. Capability of the RV to maintain appropriate output and the fill of the LVAD is the main point for correct LVAD functioning and patients' early and late postoperative outcome. Preimplantation evaluation by echocardiography estimation of RV function, geometry and tricuspid valve function are the criteria for the diagnose of RV dysfunction. Laboratory analysis which can lead to the diagnose of RV dysfunction are also included in preimplantation evaluation. Specific inotropic therapy in patients with moderate or severe RV dysfunction and/or dilatation can improve RV function in preimplantation period. This is predominantly important in patients who were on the prolonged inotropic support with beta-agonist therapy before LVAD implantation and in whom their beta receptors are exhausted. The investigators will exam the hemodynamic effects of levosimendan administrated day before in patients underwent LVAD implantation. Further, investigators will analyze and evaluate early and late outcome in participants with implanted LVAD.

Study Timeline

• Study Start: 2009-06-01
• Study First Submitted: 2018-06-24
• Study First Submitted QC: 2018-09-03
• Study First Posted: 2018-09-06
• Status Verified: 2019-10
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-03
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All patients scheduled for LVAD implantation

Exclusion Criteria

• Known patient's allergy on medication
• Patient's disagreement for the procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Levosimendan before LVAD implantation	Levosimendan 2.5 MG/ML Injectable Solution	Levosimendan use 24 hrs. before LVAD implantation

Primary Outcome Measures

Name	Time	Method
Measurement of laboratory parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotropic day before surgery	9 years	Patients will be divided into two groups depending of administrated inotropic pretreatment (levosimendan or other inotropic medications) in preoperative period. Further, laboratory data will be collected and analyzed three times in day before surgery and every four hours during first postoperative day after LVAD implantation to estimate changes and improvement/worsening of laboratory parameters depending of preoperative treatment.
Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery	9 years	Patients will be divided into two groups depending of administrated inotropic pretreatment (levosimendan or other inotropic medications) in preoperative period. Further, hemodynamic data will be collected and analyzed three times in day before surgery and every four hours during first postoperative day after LVAD implantation to estimate changes in hemodynamic outcome depending of preoperative treatment. Hemodynamic parameter 7 and its changes is right ventricular end-diastolic volume (RVEDV) expressed by mL.
Measurement of echocardiography parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotropic day before surgery	9 years	Patients will be divided into two groups depending of administrated inotropic pretreatment (levosimendan or other inotropic medications) in preoperative period. Echocardiography data will be collected and analyzed three times in day before surgery and every four hours during first postoperative day after LVAD implantation to estimate changes and improvement/worsening of echocardiography parameters depending of preoperative treatment.

Trial Locations

Locations (1)

Nikola Bradic; 🇭🇷 Zagreb, Croatia