Changes of body compositions (body water, muscle mass etc.) after levosimendan treatment in patients with advanced heart failure

Phase 1

Conditions: Advanced heart failure
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2018-001623-39-AT

Lead Sponsor: Verein zur Förderung der Forschung auf dem Gebiet der Arteriosklerose, Thrombose und vaskulären Biologie (ATVB)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

Inclusion Criteria

1.Male / female, = 18 to = 85 years of age at baseline study visit
2.Written informed consent
3.Advanced heart failure:
a.Reduced LVEF
b.NYHA II-IV
c.NT-proBNP = 125 ng/l
d.Standard of Care heart failure treatment (ACE inhibitor + ß-blocker , if tolerated)
e.Chronic heart failure (SoC heart failure treatment > 30 days)
4.Admitted for levosimendan treatment (interventional group) / no levosimendan treatment (control group)

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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1.Age =18 or = 85 years of age at baseline study visit
2.History of alcohol or drug addiction in the last 12 months
3.Pregnancy or breastfeeding
4.Subject unable to comply with follow up visits
5.Inability to give informed consent
6.Allergy or hypersensitivity to levosimendan

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main aim of the study is to assess changes of body composition and hemodynamic parameters after levosimendan treatment in patients with advanced heart failure compared to baseline and control group. ;Secondary Objective: The secondary objectives of the study are to investigate changes of laboratory values associated with heart failure, quality of life and functional capacity in patients with advanced heart failure compared to baseline and control group, in order to find potential prognostic parameters for a better treatment response.<br><br><br>;Primary end point(s): Improvement of body composition and hemodynamic parameters after levosimendan treatment;Timepoint(s) of evaluation of this end point: 1 day, 7 days and 31 days after levosimendan treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): improvement of laboratory values associated with heart failure (eg NT-proBNP, troponin, creatinine etc.)<br>improvement of quality of life<br>improvement in functional capacity (6-MWT)<br>identification of prognostic parameters for better treatment response to levosimendan;Timepoint(s) of evaluation of this end point: 1 day, 7 days and 31 days after levosimendan treatment