Loading clinical trials...

Pharmacokinetics of Inhaled Levosimendan | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Pharmacokinetics of Inhaled Levosimendan

NCT06387862•Universitair Ziekenhuis Brussel

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Locations (1)

UZ Brussel

Brussels, Belgium

Key Dates

Start Date

February 1, 2024

Primary Completion Date

November 1, 2024

Completion Date

January 1, 2025

Last Updated

May 20, 2024

Enrollment

ESTIMATED participants

Conditions

Left Ventricular Dysfunction

Interventions

Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Inhaled

DRUG

Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Intravenous

DRUG

Contacts

Matthias Raes, MD

CONTACT

024749872 matthias.raes@uzbrussel.be

Marie-Claire Van Malderen, SC

CONTACT

024763110 marieclaire.vanmalderen@uzbrussel.be

London Valvular Heart Disease and Reduced Ejection Fraction Detection in a Multi-ethnic Community Using Cardiac Ultrasound

NCT05208567

Heart Valve DiseasesLeft Ventricular Dysfunction

View study

RECRUITINGNA

The C-MIC-II Follow-Up Study

NCT05189860

Systolic Left Ventricular Dysfunction

View study

RECRUITINGNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pharmacokinetics of Inhaled Levosimendan

Inclusion Criteria

Exclusion Criteria

London Valvular Heart Disease and Reduced Ejection Fraction Detection in a Multi-ethnic Community Using Cardiac Ultrasound

The C-MIC-II Follow-Up Study

Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor

Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling

Assement of Left Ventricular Function Before Decannulation in Cardiac Surgery :Visual Estimation vs TEE

UC-MSC Transplantation for Left Ventricular Dysfunction After AMI