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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003497-48 | EudraCT Number | ||
| 2019/ABM/01/00037 | Other Grant/Funding Number | Medical Research Agency (ABM) |
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| Name | Class |
|---|---|
| Medical University of Vienna | OTHER |
| Medical University of Graz | OTHER |
| University Clinical Center of the Medical University of Warsaw | UNKNOWN |
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National, multicenter, randomized, double-blind, parallel-group, stratified by SGLT-2 inhibitor type, placebo-controlled trial, - a Phase III study. Primary objective of the study is to investigate the impact of SGLT-2 inhibitors (Empagliflozin and Dapagliflozin) on clinical endpoints in patients hospitalized with acute/decompensated HF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGLT 2 Inhibitor | Active Comparator | Empagliflozin (n=341) or Dapagliflozin (n=341): 9 months of treatment |
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| Placebo with a switch to SGLT 2 Inhibitor | Placebo Comparator | Placebo (n=682) for 3 months of treatment with a subsequent switch to Empagliflozin (n=341) or Dapagliflozin (n=341): 6 months of treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 10 MG | Drug | once daily for 6 or 9 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to first event of adjudicated cardiovascular (CV) death, or adjudicated hospitalization for heart failure in patients with heart failure with reduced ejection fraction (HFrEF) | combined endpoint | at 3 and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the number of recurrent hospitalizations due to heart failure between the treatment groups | recurrent hospitalizations due to heart failure | at 3 and 9 months |
| Difference in the number of hospitalizations for CV causes between the treatment groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Marek Postula, MD PhD | Contact | 0048 22 1166160 | mpostula@wum.edu.pl | |
| Prof. Jolanta M. Siller-Matula, MD PhD | Contact | Jolanta.Siller-Matula@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Autonomous Public Specialist Western John Paul II Hospital | Recruiting | Grodzisk Mazowiecki | Poland |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| C529054 | dapagliflozin |
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| Jerzy Popiełuszko Bielański Hospital in Warsaw |
| UNKNOWN |
| Regional Polyclinical Hospital in Kielce | UNKNOWN |
| University Clinical Hospital Military Medical Academy, Central Veterans Hospital in Łódź | UNKNOWN |
| Medical University of Gdansk | OTHER |
| Autonomous Public Specialist Western John Paul II Hospital in Grodzisk Mazowiecki | UNKNOWN |
| Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz | OTHER |
| Poznan University of Medical Sciences | OTHER |
| John Paul II Hospital, Krakow | OTHER |
| Ludwik Rydygier Regional Polyclinical Hospital in Toruń | UNKNOWN |
| University Teaching Hospital in Białystok | UNKNOWN |
| Medical University of Silesia in Katowice | UNKNOWN |
Two arms with a subsequent stratification based on the SGLT2 inhibitor type.
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double blind
| Dapagliflozin 10 MG | Drug | once daily for 6 or 9 months |
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| Placebo | Drug | once daily for 3 months |
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hospitalizations for CV causes |
| at 3 and 9 months |
| Difference in the number of hospitalizations for other than CV causes between the treatment groups | hospitalizations for other than CV causes | at 3 and 9 months |
| Time to adjudicated CV death | CV death | at 3 and 9 months |
| Time to adjudicated all cause death | all cause death | at 3 and 9 months |
| Time to adjudicated myocardial infarction | myocardial infarction | at 3 and 9 months |
| eGFR (Estimated Glomerular Filtration Rate) (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation)) creatine slope of change from baseline between the treatment groups | eGFR | at 3 and 9 months |
| Difference in the number of hospital re-admissions due to heart failure between the treatment groups | hospital re-admissions due to heart failure | at 3 and 9 months |
| Difference in the number of hospital re-admissions for any cause between the treatment groups | hospital re-admissions for any cause | at 3 and 9 months |
| Difference in the duration of hospital stay between the treatment groups after initiation of the study treatment | duration of hospital stay | at 3 and 9 months |
| Difference in the number of incidences of new onset AF and re-occurrence of AF between treatment groups | new onset AF | at 3 and 9 months |
| Difference in the change of ejection fraction in echocardiography between treatment groups | ejection fraction | at 3 and 9 months |
| Difference in the change of left ventricular diastolic function in echocardiography | left ventricular diastolic function | at 3 and 9 months |
| Difference in the change of LV strain analysis in echocardiography | LV strain | at 3 and 9 months |
| The time-averaged proportional change in NT-proBNP from | NT-proBNP | at 3 and 9 months |
| The time-averaged proportional change in selected miRNA expression linked to hypertrophy, inflammation, fibrosis, apoptosis, electric stability between treatment groups and placebo group | miRNA expression | at 3 and 9 months |
| The time-averaged proportional change in pre-specified biomarkers | biomarkers | at 3 and 9 months |
| Change from baseline in clinical summary score (HF (Chronic Heart Failure) symptoms and physical limitations domains) of the Kansas City Cardiomyopathy Questionnaire (KCCQ) | HF score | at 3 and 9 months |