NCT03659851

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 3, 2020

Status Verified

October 1, 2019

Enrollment Period

11.6 years

First QC Date

June 24, 2018

Last Update Submit

April 2, 2020

Conditions

Left Ventricular DysfunctionRight Ventricular DysfunctionBiventricular Failure

Keywords

Heart failureLeft ventricular dysfunction

Outcome Measures

Primary Outcomes (9)

  • Measurement of laboratory parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotropic day before surgery

    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.

    9 years

  • Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery

    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 1 and its changes is systemic vascular resistance index (SVRI); expressed by dyn·sec/cm5/m2

    9 years

  • Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery

    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 2 and its changes is pulmonary vascular resistance index (PVRI), expressed by dyn·sec/cm5/m2

    9 years

  • Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery

    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 3 and its changes is cardiac index (CI) expressed by L/min per m2

    9 years

  • Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery

    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 4 and its changes is right stroke work indexes (RVSWI) expressed by g·m/m2/beat

    9 years

  • Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery

    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 5 and its changes is left stroke work indexes (LVSWI) expressed by g·m/m2/beat

    9 years

  • Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery

    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 6 and its changes is stroke volume index (SVI) expressed by mL/m2

    9 years

  • Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery

    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.

    9 years

  • Measurement of echocardiography parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotropic day before surgery

    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.

    9 years

Study Arms (2)

Levosimendan before LVAD implantation

Levosimendan use 24 hrs. before LVAD implantation

Drug: Levosimendan 2.5 MG/ML Injectable Solution

Dobutamine/milrinone before LVAD implantation

Dobutamine/milrinone use 24 hrs. before LVAD implantation

Interventions

Levosimendan 2.5 MG/ML Injectable SolutionDRUG

LVAD implantation

Also known as: Simdax
Levosimendan before LVAD implantation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All patients scheduled for LVAD implantation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nikola Bradic

Zagreb, 10000, Croatia

RECRUITING

Related Publications (2)

  • 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.

    PMID: 22157071BACKGROUND

  • 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.

    PMID: 24147881BACKGROUND

MeSH Terms

Conditions

Ventricular Dysfunction, LeftVentricular Dysfunction, RightHeart Failure

Interventions

Simendan

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Nikola Bradic, MD

CONTACT

+385 91 589 3480nbradic@kbd.hr

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2018

First Posted

September 6, 2018

Study Start

June 1, 2009

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

April 3, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)