UnknownPhase 2

Pharmacokinetics of Inhaled Levosimendan

Belgium6 participantsStarted 2024-02-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 (pot…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Bioavailability of inhaled levosimendan

Timeframe: 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

Elimination half-life of inhaled levosimenan

Trial details

NCT IDNCT06387862

SponsorUniversitair Ziekenhuis Brussel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11

Contact for this trial

Matthias Raes, MD

024749872 matthias.raes@uzbrussel.be

View on ClinicalTrials.gov More Left Ventricular Dysfunction trials