Left Ventricular DysfunctionPhase 2SymbiovNCT06387862
Pharmacokinetics of Inhaled Levosimendan
A Phase 2 study testing Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Inhaled and Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Intravenous in people with Left Ventricular Dysfunction, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Determination of biological availability, time-to-peak and elimination half-life of inhaled levosimendan by administration of an inhaled- and intravenous dose of levosimendan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Dysfunction
- What is being tested?
- Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Inhaled and Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2024to Jan 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject >18 years of age
- Scheduled for elective coronary artery bypass grafting (CABG)
- Provided written informed consent
- Impaired left ventricular function (LVEF <40%)
Who cannot join
- Known allergy for levosimendan or solutes
- Persistent angina, defined as Canadian Cardiovascular Society score > I
- History of valvular intervention or uncorrected primary stenotic valve disease
- Uncorrected thyroid disease
- Infiltrative, hypertrophic or restrictive cardiomyopathy
- Pericardial disease
Show all 17Show fewer
- Active myocarditis
- Chronic obstructive pulmonary disease requiring long-term treatment with β-agonists, Theophylline, or corticosteroids (FEV1 < 80%; Tiffeneau-index <0.7)
- History of serious arrhythmias, defined as a history of ventricular tachycardia or fibrillation other than that occurring within 24 hours after acute myocardial infarction (MI)
- resting heart rate > 115 bpm for at least 10 minutes on repeated measurements
- Supine systolic blood pressure < 85 mm Hg or >200 mm Hg
- patients with implanted pacemaker/defibrillator or cardiac resynchronisation therapy (CRT-device)
- primary renal or hepatic impairment (creatinine > 2.5 mg/dL or aspartate aminotransferase/alanine aminotransferase >2 times upper limit of normal and/or increased level of bilirubin (> 2 times the upper limit of normal and increase of international normalised ratio (INR) above the upper limit of normal, respectively)
- Uncorrected hypokalemia or hyperkalemia (potassium <3.5 mmol/L or >5.5 mmol/L)
- Uncorrected hypomagnesemia (magnesium <0.65mmol/L)
- Treatment with another investigational agent within 30 days before study entry
- Intubated and mechanically ventilated at the time of study entry
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Brussels, 1090
Matthias Raes, MD, 024749872, matthias.raes@uzbrussel.be
Marie-Claire Van Malderen, SC, 024763110, marieclaire.vanmalderen@uzbrussel.be
About this study
Determination of biological availability, time-to-peak and elimination half-life of inhaled levosimendan by administration of an inhaled- and intravenous dose of levosimendan.
- Conditions
- Left Ventricular Dysfunction
- Being tested
- Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Inhaled, Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Intravenous
- Keywords
- levosimendan, inhalation, pharmakokinetic
- Medical subject headings
- Ventricular Dysfunction, Left, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levosimendan 2.5 milligram/milliliter Injectable Solutiondose InhaledDrug
Each patient will receive 12µg/kg of levosimendan by inhalation over 10 min. During 10h following inhaled dose, plasma concentrations will be measured.
Levosimendan 2.5 milligram/milliliter Injectable Solutiondose IntravenousDrug
Each patient will receive 12µg/kg of levosimendan by intravenous (IV) administration over 10 min and at the same timepoints plasma samples will be measured
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan inhalation | Experimental | Levosimendan 12µg/kg inhalation over 10 minutes, once Receives: Drug: Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Inhaled |
| Levosimendan intravenous | Active comparator | Levosimendan 12µg/kg intravenous over 10 minutes, once Receives: Drug: Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of inhaled levosimendan
Assessment of bioavailability of inhaled levosimendan in spontaneous breathing patients,
Measured: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Time-to-peak of inhaled levosimendan
Assessment of time-to-peak plasma concentration of inhaled levosimendan in spontaneous breathing patients
Measured: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Elimination half-life of inhaled levosimenan
Assessment of elimination half-life of inhaled levosimendan in spontaneous breathing patients
Measured: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Secondary outcomes (7)
Effect of inhaled levosimendan on MAP
Assessment of effect of inhaled levosimendan on invasively-measured hemodynamic parameter mean arterial blood pressure (MAP)
Measured: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Effect of inhaled levosimendan on TVR
Assessment of effect of inhaled levosimendan on invasively-measured hemodynamic parameter total vascular resistance (TVR)
Measured: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Effect of inhaled levosimendan on CO
Assessment of effect of inhaled levosimendan on invasively-measured hemodynamic parameter Cardiac Output (CO)
Measured: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Effect of inhaled levosimendan on LVOT VTI
Assessment of effect of inhaled levosimendan on echocardiography-derived parameter left -ventricular-outflow-tract (LVOT) velocity-time-integral (VTI) as marker for cardiac output
Measured: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Effect of inhaled levosimendan on FAC of the right vetricle
Assessment of effect of inhaled levosimendan on echocardiography-derived parameter Fractional-Area-Change (FAC) of the right ventricle as marker of right ventricular function
Measured: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Effect of inhaled levosimendan on S'
Assessment of effect of inhaled levosimendan on echocardiography-derived parameter S' wave velocity as marker of right ventricular function
Measured: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Effect of inhaled levosimendan on SPAP
Assessment of effect of inhaled levosimendan on echocardiography-derived parameter (SPAP) systolic pulmonary artery pressure
Measured: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Feb 2024
- Primary completionNov 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular DysfunctionStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Raes, MD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387862
- Sponsor's protocol ID
- 2022SIMBIOV
- Acronym
- Symbiov
- Status last verified
- Oct 2023
- First submitted
- 9 Jan 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Inhaled Levosimendan
- ClinicalTrials.gov ID
- NCT06387862
- Acronym / sponsor ID
- Symbiov / 2022SIMBIOV
- Conditions
- Left Ventricular Dysfunction
- Keywords
- levosimendan, inhalation, pharmakokinetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 29 Apr 2024 (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.
Determination of biological availability, time-to-peak and elimination half-life of inhaled levosimendan by administration of an inhaled- and intravenous dose of levosimendan.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levosimendan inhalation | Experimental | Drug: Levosimendan 2.5 milligram/milliliter Injectable Solutiondose InhaledLevosimendan 12µg/kg inhalation over 10 minutes, once |
| Levosimendan intravenous | Active comparator | Drug: Levosimendan 2.5 milligram/milliliter Injectable Solutiondose IntravenousLevosimendan 12µg/kg intravenous over 10 minutes, once |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject >18 years of age
- Scheduled for elective coronary artery bypass grafting (CABG)
- Provided written informed consent
- Impaired left ventricular function (LVEF <40%)
Key exclusion criteria (17 listed)
- Known allergy for levosimendan or solutes
- Persistent angina, defined as Canadian Cardiovascular Society score > I
- History of valvular intervention or uncorrected primary stenotic valve disease
- Uncorrected thyroid disease
- Infiltrative, hypertrophic or restrictive cardiomyopathy
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 milligram/milliliter Injectable Solutiondose InhaledEach patient will receive 12µg/kg of levosimendan by inhalation over 10 min. During 10h following inhaled dose, plasma concentrations will be measured. | Drug | Levosimendan inhalation |
| Levosimendan 2.5 milligram/milliliter Injectable Solutiondose IntravenousEach patient will receive 12µg/kg of levosimendan by intravenous (IV) administration over 10 min and at the same timepoints plasma samples will be measured | Drug | Levosimendan intravenous |
Primary outcome
Bioavailability of inhaled levosimendan
Time frame: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Assessment of bioavailability of inhaled levosimendan in spontaneous breathing patients,
Time-to-peak of inhaled levosimendan
Time frame: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Assessment of time-to-peak plasma concentration of inhaled levosimendan in spontaneous breathing patients
Elimination half-life of inhaled levosimenan
Time frame: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Assessment of elimination half-life of inhaled levosimendan in spontaneous breathing patients
7 secondary outcomes
Effect of inhaled levosimendan on MAP
Time frame: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Effect of inhaled levosimendan on TVR
Time frame: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Effect of inhaled levosimendan on CO
Time frame: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Effect of inhaled levosimendan on LVOT VTI
Time frame: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Effect of inhaled levosimendan on FAC of the right vetricle
Time frame: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Effect of inhaled levosimendan on S'
Time frame: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Effect of inhaled levosimendan on SPAP
Time frame: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- 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.
Matthias Raes, MD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Inhaled and Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Intravenous in people with Left Ventricular Dysfunction, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 4 inclusion and 17 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 20 May 2024. 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 Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Matthias Raes, MD (024749872, matthias.raes@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioavailability of inhaled levosimendan (time frame: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2024.