Inhaled levosimendan for heart function improvement

Pharmacokinetics of Inhaled Levosimendan

This study tests if inhaled levosimendan can improve heart function in patients with left ventricular dysfunction by comparing how well it works when taken by inhalation versus through an IV.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universitair Ziekenhuis Brussel (Academic / other)
• Locations: 1 site (Brussel)
• Trial ID: NCT06387862 on ClinicalTrials.gov

What this trial studies

This study investigates the pharmacokinetics of inhaled levosimendan, focusing on its biological availability, time-to-peak concentration, and elimination half-life. Participants will receive both inhaled and intravenous doses of levosimendan to compare the two methods of administration. The study aims to determine how effectively inhaled levosimendan can be absorbed and utilized by the body in patients with left ventricular dysfunction. This phase 2 trial is crucial for understanding the potential benefits of inhaled levosimendan in clinical settings.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 scheduled for elective coronary artery bypass grafting with left ventricular ejection fraction less than 40%.

Not a fit: Patients with known allergies to levosimendan, severe heart conditions, or chronic obstructive pulmonary disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a new inhalation treatment option for patients with impaired heart function.

How similar studies have performed: While inhaled levosimendan is a novel approach, similar studies have shown promise in improving heart function, indicating potential for success.

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

Where this trial is running

Brussel

• UZ Brussel — Brussel, Belgium (Recruiting)

Study contacts

• Principal investigator: Matthias Raes, MD — Universitair Ziekenhuis Brussel
• Study coordinator: Matthias Raes, MD

Conditions Left Ventricular Dysfunction; levosimendan; inhalation; pharmakokinetic