E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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)
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement of body composition and hemodynamic parameters after levosimendan treatment |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 day, 7 days and 31 days after levosimendan treatment |
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E.5.2 | 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 day, 7 days and 31 days after levosimendan treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Patients with advanced heart failure, currently sufficiently treated with Standard of Care treatment |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |