Levosimendan In Ambulatory Heart Failure Patients

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to determine the efficacy of repeated infusions of levosimendan in the group of outpatients with advanced systolic heart failure (HF).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Bialystok
• Collaborators: Azienda Ospedaliera dei Colli; Institute of Cardiology, Warsaw, Poland; John Paul II Hospital, Krakow; Medical Research Agency; Medical University of Lodz; Medical Universtity of Lodz; Nicolaus Copernicus University; Poznan University of Medical Sciences; University of Opole
• Treatments: Simendan

Criteria

Inclusion Criteria:

• Informed consent obtained before any trial activities

• Male or female, age ≥ 18 years at the time of signing informed consent

• Left ventricle ejection fraction ≤ 35%

• Hospitalization due to worsening of HF within the last 3 months

• New York Heart Association functional class III or outpatient IV

• Individually optimized pharmacotherapy, based on the current European Society of Cardiology recommendations, stable for at least 1 month prior to randomization, according to the knowledge and experience of the qualifying clinician

• Distance covered in six-minute walk test <350m OR NTproBNP concentration ≥ 1000 pg/mL

• In the opinion of the Investigator, the patient does not currently require hospitalization

• Patient protected with an implantable device capable of terminating life-threatening arrhythmias and conduction disturbances (ICD or cardiac resynchronisation therapy-D/P), if indicated and the patient consents to implantation.

Exclusion Criteria:

• Known or suspected hypersensitivity to trial products or related products,

• Restrictive or hypertrophic cardiomyopathy, uncorrected severe valvular disease, potentially reversible cause of HF

• Hypotension with symptoms of tissue hypoperfusion

• Uncontrolled hypertension

• Planned revascularization or other surgical treatment of HF within the next year

• Advanced chronic kidney disease

• Features of liver damage

• Severe chronic lung disease with features of respiratory distress or severe abnormal spirometry or home oxygen treatment

• Accompanying chronic diseases with poor prognosis

• Paroxysmal supraventricular tachycardia, paroxysmal ventricular tachycardia, torsade de pointes, advanced atrioventricular blocks within one month prior to screening

• Receipt of any investigational product within 30 days before screening visit

• Any disorder, which in the investigator's opinion may jeopardise subject's safety or compliance with the study protocol and procedures