Effect of Flozin (dapagliflozin) Administration on Myocardial and Peripheral Vascular Remodeling
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Identify factors that predict remodeling and enhancement of left ventricular (LV) systolic and diastolic function within 12 months.
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosed heart failure NYHA class II and III
- •consent to participate in the study
- •patients should already be receiving treatment with an ACE inhibitor or sacubitril/valsartan or sartans, a beta-blocker, and an MRA, and should start on SGLT2i as part of therapy enhancement
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Identify factors that predict remodeling and enhancement of left ventricular (LV) systolic and diastolic function within 12 months.
Time Frame: 6 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.
Secondary Outcomes
- Assessment of the combined outcome including deaths from cardiovascular causes, defibrillator discharges, hospitalizations or episodes of atrial fibrillation.(Baseline ut to 12 months)
Investigators
Arkadiusz Niklas
Poznan University of Medical Sciences
Poznan University of Medical Sciences