NCT06387862 - Pharmacokinetics of Inhaled Levosimendan | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

6

Conditions

Left Ventricular Dysfunction

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject \>18 years of age * Scheduled for elective coronary artery bypass grafting (CABG) * Provided written informed consent * Impaired left ventricular function (LVEF \<40%) Exclusion Criteria: * 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 * 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

Locations (1)

UZ Brussel

Brussels, Belgium

RECRUITING