Effect of Flozin (dapagliflozin) Administration on Myocardial and Peripheral Vascular Remodeling
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Identify factors that predict remodeling and enhancement of left ventricular (LV) systolic and diastolic function within 12 months.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Identify factors that predict remodeling and enhancement of left ventricular (LV) systolic and diastolic function within 12 months.
时间窗: 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.
次要结局
- Assessment of the combined outcome including deaths from cardiovascular causes, defibrillator discharges, hospitalizations or episodes of atrial fibrillation.(Baseline ut to 12 months)
研究者
Arkadiusz Niklas
Poznan University of Medical Sciences
Poznan University of Medical Sciences