E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute coronary syndrome treated with percutaneous coronary intervention (PCI) Patients suffering from acute heart failure after the procedure will be randomised to the study |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000803 |
E.1.2 | Term | Acute heart failure |
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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 hypothesis of the study is that Levosimendan infusion added on the top of standard therapy facilitates the clinical symptoms and hemodynamic parameters in heart failure due to acute myocardial infarction. The primary end point is invasively measured decrease in pulmary artery capillary wedge pressure (PCWP) during 48 hours. |
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E.2.2 | Secondary objectives of the trial |
Secondary objective is to study the safety of Levosimendan in acute coronary syndrome patients |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria
A. Acute coronary syndrome - unstable angina, NSTEMI (non ST-elevation myocardial infarction), or STEMI (ST-elevation myocardial infarction) according to current guidelines.
and
B. symptoms and signs of heart failure: 1. hypoxia and dyspnea at rest due to decompensated CHFo 2. increased filling pressure (pulmonary artery wedge pressure (PCWP) > 20 mmHg) by Swan-gantz catheter or by echocardiographic estimation.
C. Written informed consent by patient or a close relative
D. Age >18 years
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E.4 | Principal exclusion criteria |
Exclusion criteria
• Pregnancy • Cardiogenic shock • Systolic arterial pressure below 100 mmHg despite of adequate fluid balance • Heart rate > 120 bpm • Sustained ventricular tachycardia not related to early perfusion • Use of intravenous ß-adrenergic agonists during admission within 24 hours before screening , and intravenous PDE inhibitors (e.g., milrinone, amrinone) within 2 days. • Vasopressor treatment • Pneumonia or sepsis • ARDS; hypoxemia due to severe COPD • Heart failure due to restrictive or hypertrophic cardiomyopathy or to uncorrected stenotic valvular disease • Planned surgery • Known hypersensitivity to study medication • Known history of Torsades de pointes • hypo- or hyperkalemia • significant renal or hepatic failure • intra aortic balloon pump or left ventricular assist device
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E.5 End points |
E.5.1 | Primary end point(s) |
Area under the curve for the decrease in invasively measured pulmonary artery capillary pressure (PCWP) during 48 h after beginning of study medication (levosimendan or placebo) treatment.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |