E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Myocardial infarction |
Myokardinfarkt |
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E.1.1.1 | Medical condition in easily understood language |
Myocardial infarction |
Herzinfarkt |
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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 primary objective is to investigate the impact of Empagliflozin on biomarkers of heart failure in patients with myocardial infarction with and without type 2 diabetes mellitus within 6 months after the event. |
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E.2.2 | Secondary objectives of the trial |
To investigate - Short term changes of nt-proBNP levels - Short term and intermediate term changes in echocardiography parameters - Change in levels of ketone body concentrations - Change in HbA1c levels - Change in body weight - Number of hospital re-admissions due to heart failure or other causes - Duration of hospital stay - All-cause mortality
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1)Myocardial infarction with evidence of significant myocardial necrosis defined as a rise in creatinine kinase >800 U/l and a troponin T- or I level >10x ULN. In addition at least 1 of the following criteria must be met: - Symptoms of ischemia - ECG changes indicative of new ischemia (new ST-T changes or new LBBB) - Imaging evidence of new regional wall motion abnormality 2)18 – 80 years of age 3)Informed consent has to be given in written form. 4)eGFR > 45 ml/min/1.73m2 5)Blood pressure before first drug dosing >110 mmHg 6)Blood pressure before first drug dosing >70 mmHg 7)First intake of study medication ≤72h after myocardial infarction
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E.4 | Principal exclusion criteria |
1)Any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis 2)Blood pH < 7,32 3)Known allergy to SGLT-2 inhibitors 4)Haemodynamic instability as defined by intravenous administration of catecholamine, calciumsensitizers or phosphodiesterase inhibitors 5)>1 episode of severe hypoglycemia within the last 6 months and treatment with insulin or sulfonylurea 6)Females of child bearing potential without adequate contraceptive methods (i.e. sterilisation, intrauterine device, vasectimized partner; or medical history of hysterectomy) 7)Acute symptomatic urinary tract infection (UTI) or genital infection 8)Patients currently being treated with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin) or having received treatment with any SGLT-2 inhibitor within the 4 weeks prior to the screening visit |
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference in the change of nt-proBNP levels between treatment groups from randomization to week 26 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Difference in the change of EF between treatment groups from randomization to week 26 -Difference in the change of EF between treatment groups from randomization to week 6 -Difference in the change of left ventricular diastolic function from randomization to week 26 -Difference in the change of left ventricular diastolic function from randomization to week 6 -Difference in the change of nt-proBNP levels between treatment groups from randomization to week 6 -Difference in the change of HbA1c between treatment groups from randomization to week 26 (in subjects with known T2DM) -Difference in the change of body weight between treatment groups from randomization to week 6 -Difference in the change of body weight between treatment groups from randomization to week 26 -Difference in the change of blood beta-hydroxybutyrate levels between the treatment groups from randomization to week 6 -Difference in the change of blood beta-hydroxybutyrate levels between the treatment groups from randomization to week 26 -Difference in the number of hospital re-admissions due to heart failure between the treatment groups -Difference in the number of hospital re-admissions for any cause between the treatment groups -Difference in the duration of hospital stay between the treatment groups after initiation of the study treatment
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
baseline, week 6 and week 26 |
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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 | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
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 | |
E.8.9.1 | In the Member State concerned months | 30 |
E.8.9.1 | In the Member State concerned days | |