Left Ventricular DysfunctionNCT03659851
Levosimendan In Patients Undergoing LVAD Implantation
An observational study of Left Ventricular Dysfunction and Right Ventricular Dysfunction, run by University Hospital Dubrava at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Left Ventricular Dysfunction, Right Ventricular Dysfunction, Biventricular Failure
- What is being tested?
- Levosimendan 2.5 MG/ML Injectable Solution
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jun 2009to 31 Dec 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients scheduled for LVAD implantation
Who cannot join
- Known patient's allergy on medication
- Patient's disagreement for the procedure
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Nikola Bradic
Zagreb, 10000
Nikola Bradic, MD, +385 91 589 3480, nbradic@kbd.hr
About this study
Official title: Pretreatment With Levosimendan In Patients Undergoing Left Ventricular Assist Device Implantation
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.
Read the 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.
- Being tested
- Levosimendan 2.5 MG/ML Injectable Solution
- Keywords
- Heart failure, Left ventricular dysfunction
- Medical subject headings
- Ventricular Dysfunction, Left, Ventricular Dysfunction, Right, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levosimendan 2.5 MG/ML Injectable SolutionDrug
Also called Simdax
LVAD implantation
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan before LVAD implantation | Levosimendan use 24 hrs. before LVAD implantation Receives: Drug: Levosimendan 2.5 MG/ML Injectable Solution | |
| Dobutamine/milrinone before LVAD implantation | Dobutamine/milrinone use 24 hrs. before LVAD implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start1 Jun 2009
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikola Bradic, MD, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659851
- Sponsor's protocol ID
- UH Dubrava
- Status last verified
- Oct 2019
- First submitted
- 24 Jun 2018
- Last updated
- 3 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22157071Theiss 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.
PubMed 24147881
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pretreatment With Levosimendan In Patients Undergoing Left Ventricular Assist Device Implantation
- ClinicalTrials.gov ID
- NCT03659851
- Acronym / sponsor ID
- UH Dubrava
- Keywords
- Heart failure, Left ventricular dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- 1 Jun 2009 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levosimendan before LVAD implantation | – | Drug: Levosimendan 2.5 MG/ML Injectable SolutionLevosimendan use 24 hrs. before LVAD implantation |
| Dobutamine/milrinone before LVAD implantation | – | –Dobutamine/milrinone use 24 hrs. before LVAD implantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients scheduled for LVAD implantation
Key exclusion criteria (2 listed)
- Known patient's allergy on medication
- Patient's disagreement for the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levosimendan 2.5 MG/ML Injectable SolutionAlso: SimdaxLVAD implantation | Drug | Levosimendan before LVAD implantation |
Primary outcome
Measurement of laboratory parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotropic day before surgery
Time frame: 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
Time frame: 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 1 and its changes is systemic vascular resistance index (SVRI); expressed by dyn·sec/cm5/m2
Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery
Time frame: 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 2 and its changes is pulmonary vascular resistance index (PVRI), expressed by dyn·sec/cm5/m2
Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery
Time frame: 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 3 and its changes is cardiac index (CI) expressed by L/min per m2
Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery
Time frame: 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 4 and its changes is right stroke work indexes (RVSWI) expressed by g·m/m2/beat
Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery
Time frame: 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 5 and its changes is left stroke work indexes (LVSWI) expressed by g·m/m2/beat
Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery
Time frame: 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 6 and its changes is stroke volume index (SVI) expressed by mL/m2
Measurement of hemodynamic parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotrope day before surgery
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Background: PubMed 22157071Sponga 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.
- Background: PubMed 24147881Theiss 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Dysfunction and Right Ventricular Dysfunction, run by University Hospital Dubrava at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikola Bradic, MD (+385 91 589 3480, nbradic@kbd.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of laboratory parameters in patients who underwent LVAD implantation and pretreated with levosimendan or other inotropic day before surgery (time frame: 9 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03659851, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.