Effect of repetitive levosimendan treatment on clinical outcomes of chronic heart failure patients: focus on optimal patient selection based on novel cardiac biomarkers.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004193-18-HU

Enrollment

Registered

2016-10-24

Start date

2017-02-16

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

A total of 80 symptomatic patients with severe ischaemic or non-ischaemic cardiomyopathy will be enrolled in the study. Those, who were implanted a device and proved to be non-responders or low responders with ischaemic etiology would be separetly investigated.

Interventions

Trade Name: Simdax Product Name: SIMDAX Product Code: Not applicable Pharmaceutical Form: Infusion Pharmaceutical form of the placebo: Solution for infusion in administration system Route of administr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Symptomatic heart failure at enrollment – NYHA III-IV treated with augmented / iv. diuretics with optimal heart failure medical treatment 2. Ischaemic patients (no STEMI/ NSTEMI in 6 months) with a device specified as: Non reposponders or low responders after CRT-P/CRT-D or after ICD implantation (at least for 6 months) 3. Ischaemic or non-ischaemic chronic heart failure without any device. 4. Age: 18-80 years 5. LVEF=65 years) yes F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

Exclusion criteria: SBP250 Severe COPD treated with steroid or more than 2 inh. therapy Severe anaemia 100 U/L Any planned surgical event or TX Pregnant Non-consent or low compliant Use of levosimendan in the patients’ history in the past 6 months

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the study is to identify patients who benefit the most from intermittent levosimendan treatment using correlations between quality of life. ;Secondary Objective: - Cardiac death/HTX or hospitalization due to heart failure - All- cause mortality - 6 MWT - Minnesota questionnaire - Echocardiographic improvement - Laboratory parameters - Traditional and novel biomarkers - Hemodynamic parameters - Incidence or new onset of arrhythmic events ;Primary end point(s): Quality of Life: Kansas city questionnaire;Timepoint(s) of evaluation of this end point: Baseline (enrollment), 4 times during the treatment monthly, 6 months after enrollment	—

Measure

Time frame

Main Objective: The main objective of the study is to identify patients who benefit the most from intermittent levosimendan treatment using correlations between quality of life. ;Secondary Objective: - Cardiac death/HTX or hospitalization due to heart failure - All- cause mortality - 6 MWT - Minnesota questionnaire - Echocardiographic improvement - Laboratory parameters - Traditional and novel biomarkers - Hemodynamic parameters - Incidence or new onset of arrhythmic events ;Primary end point(s): Quality of Life: Kansas city questionnaire;Timepoint(s) of evaluation of this end point: Baseline (enrollment), 4 times during the treatment monthly, 6 months after enrollment

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Secondary

Measure	Time frame
Secondary end point(s): - Cardiac death/HTX or hospitalization due to heart failure - All- cause mortality - 6 MWT - Minnesota questionnaire - Echocardiographic improvement - Laboratory parameters - Traditional and novel biomarkers - Hemodynamic parameters - Incidence or new onset of arrhythmic events ;Timepoint(s) of evaluation of this end point: Baseline (enrollment), 4 times during the treatment monthly, 6 months after enrollment	—

Measure

Time frame

Secondary end point(s): - Cardiac death/HTX or hospitalization due to heart failure - All- cause mortality - 6 MWT - Minnesota questionnaire - Echocardiographic improvement - Laboratory parameters - Traditional and novel biomarkers - Hemodynamic parameters - Incidence or new onset of arrhythmic events ;Timepoint(s) of evaluation of this end point: Baseline (enrollment), 4 times during the treatment monthly, 6 months after enrollment

—

Countries

Hungary

Contacts

Public ContactZsófia Doros

Semmelweis University, Heart and Vascular Center

studycenter.sekk6@gmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026