Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT01065194
Eligibility Criteria:
Inclusion Criteria:
* Patients with chronic stable heart failure NYHA III and IV diagnosed at least 3 months before inclusion
* 6-min.-walk-test \< 350 meters
* EF \< 35 %
* Age \> 20 years
* Optimized and individualised neurohormonal background therapy according to ESC-guidelines for the treatment of chronic heart failure.
* Patient has signed informed consent
Exclusion Criteria:
* Hospitalization for decompensated heart failure requiring i.v. diuretics within the last month before randomization
* History of torsades des pointes
* Allergy to Levosimendan or any of the excipients
* Administration of inotropes in the last 4 weeks
* Potassium \<3,5 and \>5,5 mmol/l
* Systolic blood pressure \<= 100 mmHg
* Women at childbearing age without using effective contraceptives ( oral contraceptives, intrauterine contraceptive devices) unless surgical sterilisation has been undertaken.
* Female patients who are pregnant or nursing
* Creatinin Clearance \< 30ml/min/m2
* Severe anemia (Hb \< 10 mg /dl)
* Mechanical obstruction affecting the ventricular filling or the outflow or both
* Patients with non compliance
* Severe conditions, which make the patient unsuitable to participate in a study as judged by the investigator
* Severe liver disease
* Percutaneous coronary intervention within the last 1 months
* Coronary bypass surgery within the last 3 months
* Planned HTX within the next six months
* Patient involved in another clinical trial
* De-nove heart failure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01065194
Study Brief:
Protocol Section:
NCT01065194