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

Assessment of body composition changes after Levosimendan treatment in patients with advanced heart failure - BCC - LEVO

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001623-39-AT

Enrollment

Registered

2018-05-04

Start date

2018-07-26

Completion date

Unknown

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced heart failure

Interventions

Trade Name: Simdax Product Name: Simdax (Levosimendan) Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: LEVOSIMENDAN CAS Number: 141505-33-1 Concentration unit: mg/ml mi

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. ;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	—

Measure

Time frame

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. ;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

Measure	Time frame
Secondary end point(s): improvement of laboratory values associated with heart failure (eg NT-proBNP, troponin, creatinine etc.) improvement of quality of life improvement in functional capacity (6-MWT) 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	—

Countries

Austria

Contacts

Public ContactATVB

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

004315863737

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: May 22, 2026