Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
6 participants
INTERVENTIONAL
2024-02-01
2025-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
NONE
Study Groups
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Levosimendan inhalation
Levosimendan 12µg/kg inhalation over 10 minutes, once
Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Inhaled
Each patient will receive 12µg/kg of levosimendan by inhalation over 10 min. During 10h following inhaled dose, plasma concentrations will be measured.
Levosimendan intravenous
Levosimendan 12µg/kg intravenous over 10 minutes, once
Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Intravenous
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
Interventions
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Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Inhaled
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 Intravenous
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
Eligibility Criteria
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Inclusion Criteria
* Scheduled for elective coronary artery bypass grafting (CABG)
* Provided written informed consent
* Impaired left ventricular function (LVEF \<40%)
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Principal Investigators
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Matthias Raes, MD
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Locations
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UZ Brussel
Brussels, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022SIMBIOV
Identifier Type: -
Identifier Source: org_study_id
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