Clinical trial NCT03659851: Levosimendan In Patients Undergoing LVAD Implantation
Official title: Pretreatment With Levosimendan In Patients Undergoing Left Ventricular Assist Device Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Left Ventricular Dysfunction
Right Ventricular Dysfunction
Biventricular Failure
Keywords: Heart failure
Left ventricular dysfunction
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In study will be observed all patients scheduled for LVAD implantation because of severe heart failure in which heart transplantation cannot be performed due to medical conditions. Further, in study will be observed all patients scheduled for LVAD implantation because of severe heart failure in which any other conservative/surgery therapy did not give positive results.

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.

Eligibility criteria: Inclusion Criteria:

* All patients scheduled for LVAD implantation

Exclusion Criteria:

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

Primary outcomes:
measure: Measurement of laboratory parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotropic day before surgery
timeFrame: 9 years
measure: Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery
timeFrame: 9 years
measure: Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery
timeFrame: 9 years
measure: Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery
timeFrame: 9 years
measure: Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery
timeFrame: 9 years
measure: Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery
timeFrame: 9 years
measure: Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery
timeFrame: 9 years
measure: Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery
timeFrame: 9 years
measure: Measurement of echocardiography parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotropic day before surgery
timeFrame: 9 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Nikola Bradic
Study officials:
References:
citation: Sponga S, Ivanitskaia E, Potapov E, Krabatsch T, Hetzer R, Lehmkuhl H. Preoperative treatment with levosimendan in candidates for mechanical circulatory support. ASAIO J. 2012 Jan-Feb;58(1):6-11. doi: 10.1097/MAT.0b013e318239f401.
citation: Theiss HD, Grabmaier U, Kreissl N, Hagl C, Steinbeck G, Sodian R, Franz WM, Kaczmarek I. Preconditioning with levosimendan before implantation of left ventricular assist devices. Artif Organs. 2014 Mar;38(3):231-4. doi: 10.1111/aor.12150. Epub 2013 Oct 22.