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The aim of this study is to assess the effect of treatment with flozin (dapagliflozin 10mg once a day) on haemodynamic parameters and myocardial and peripheral vascular remodeling in patients with NYHA class II-III heart failure.
In the available literature, there are reports of beneficial effects of flozins on improving myocardial systolic and diastolic function and isolated reports of effects on regression of organ damage (heart, vessels). These drugs significantly improve the prognosis of patients with heart failure, reduce total and cardiovascular mortality, reduce the number of exacerbations and the need for hospitalization, and have a beneficial effect on improving quality of life regardless of coexisting diabetes. New properties demonstrating the pleiotropic effect of the flozins are constantly being discovered. Drugs in this group are highly potent, selective and reversible inhibitors of the sodium ion-dependent glucose cotransporter 2 (SGLT2). The flozins have a low risk of side effects.
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| Measure | Description | Time Frame |
|---|---|---|
| Identify factors that predict remodeling and enhancement of left ventricular (LV) systolic and diastolic function within 12 months. | This study aims to identify factors that predict the remodeling and enhancement of left ventricular (LV) systolic and diastolic functions over 12 months. Using both univariate and multivariate logistic regression analyses, it will focus on finding predictors at the 6-month mark, especially through advanced echocardiography parameters and vascular stiffness test. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the combined outcome including deaths from cardiovascular causes, defibrillator discharges, hospitalizations or episodes of atrial fibrillation. | Over 12 months, the study will assess a combined outcome including cardiovascular-related deaths, defibrillator discharges, hospitalizations, or atrial fibrillation episodes. Predictors for these cardiovascular events will be analyzed using univariate and multivariate Cox analyses, with the model's quality evaluated by time-dependent ROC analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients over 18 years of age of both sexes with diagnosed heart failure NYHA class II and III.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arkadiusz Niklas, MD PhD | Contact | 0048 61 854 90 90 | aniklas@ump.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Arkadiusz Niklas, PhD | University Clinical Hospital in Poznań, 49 Przybyszewskiego Street, 60-355 Poznań | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinical Hospital in Poznań, 49 Przybyszewskiego Street, 60-355 Poznań | Recruiting | Poznan | Wielkopolska | 60-355 | Poland |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Baseline ut to 12 months |