Effect of Levosimedan on heart function and pressures during exercise in patients with severe heart failure.

Phase 1

• Conditions: Advanced chronic heart failure; MedDRA version: 20.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-002049-31-DK
• Lead Sponsor: Heart Center, Department of Cardiology, Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-10
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

•Age =18 years
•NYHA III-IV on optimal medical treatment
•LVEF =35%
•NT-proBNP >600 µg/L
•pVO2 <20 ml/kg/min
•No hospitalization for HF or change in loop diuretic <2 weeks

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

•Recent or acute coronary and respiratory syndromes
•Recent sustained ventricular tachycardia or ventricular fibrillation
•Severe aortic or mitral valve disease
•Known malfunctioning artificial heart valve
•Uncorrected obstructive valvular disease
•Hypertrophic cardiomyopathy
•Fertile women
•Uncorrected thyroid disease
•Presence of any disease/condition that might per se influence exercise performance
•Left ventricular assist device
•Pacemaker-guided heart rate at rest or during exercise
•Known contraindication for treatment with levosimendan
•Any treatment with levosimendan in the previous 6 months
•Inability to perform a VO2max test
•Symptomatic hypotension or systolic blood pressure < 90 mmHg

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified