Levosimendan In Patients Undergoing LVAD Implantation

NCT ID: NCT03659851

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-06-01
• Study Completion Date: 2021-12-31

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.

Conditions

Left Ventricular Dysfunction; Right Ventricular Dysfunction; Biventricular Failure

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Levosimendan before LVAD implantation

Levosimendan use 24 hrs. before LVAD implantation

Levosimendan 2.5 MG/ML Injectable Solution

Intervention Type: DRUG

LVAD implantation

Dobutamine/milrinone before LVAD implantation

Dobutamine/milrinone use 24 hrs. before LVAD implantation

No interventions assigned to this group

Interventions

Levosimendan 2.5 MG/ML Injectable Solution

LVAD implantation

Intervention Type: DRUG

Other Intervention Names

Simdax

Eligibility Criteria

Inclusion Criteria

• All patients scheduled for LVAD implantation

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Dubrava

OTHER

Sponsor Role: lead

Responsible Party

Nikola Bradic, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nikola Bradic

Zagreb, , Croatia

Site Status: RECRUITING

Countries

Croatia

Central Contacts

Nikola Bradic, MD

Role: CONTACT

nbradic@kbd.hr

+385 91 589 3480

Facility Contacts

Nikola Bradic, MD

Role: primary

nbradic@kbd.hr

+385 91 589 3480

References

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.

Reference Type: BACKGROUND

PMID: 22157071 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24147881 (View on PubMed)

Other Identifiers

UH Dubrava

Identifier Type: -

Identifier Source: org_study_id