Pharmacokinetics of Inhaled Levosimendan

Launched by UNIVERSITAIR ZIEKENHUIS BRUSSEL · Apr 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called inhaled levosimendan, which is being tested for its effects on patients with left ventricular dysfunction, a condition where the heart's left side isn't working properly. The goal is to understand how well the medication is absorbed into the body, how quickly it reaches its peak level in the bloodstream, and how long it stays there before being eliminated. The trial is currently recruiting participants aged 18 and older who are scheduled for a specific heart surgery called coronary artery bypass grafting (CABG) and have reduced heart function.

To join the study, participants must meet certain criteria, such as having a heart function rating of less than 40%, and they cannot have certain health issues like severe allergies to the medication or specific heart conditions. Those who participate will receive both inhaled and intravenous doses of levosimendan. It's important to know that this trial is focused on understanding how this treatment works, which may help improve care for patients with heart problems in the future. If you or someone you know is interested in joining, discussing it with a healthcare provider would be a good next step.

Gender

ALL

Eligibility criteria

• 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