Deformation Imaging by Strain in Chronic Heart Failure Over Gliflozins: an Echocardiographic Register on Sodium-GLucose coTransporter-2 Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 503
- 试验地点
- 1
- 主要终点
- Predictors of remodeling and improvement in LV systolic and diastolic function
研究概览
简要总结
It is an observational, cohort, prospective, multicentre, Italian, non-profit study, with the aim of evaluating the modification of conventional and advanced echocardiographic parameters, focusing on speckle tracking and three-dimensional echocardiography (optional), in patients with HFrEF after treatment with SGLT2i Dapagliflozin and Empagliflozin.
Participation in the study will last for approximately 18 months, and a total of 300 patients will be enrolled at the various Research Centers.
The enrolled patients will undergo a first evaluation in which the anamnestic, clinical and conventional and advanced echocardiographic data will be recorded. At this point, the patient will start SGLT2i.
After starting SGLT2i, a second evaluation will be carried out with a cardiological visit at 6 months, in which the same data listed above will then be recorded.
At the end of the evaluation, the clinical follow-up will be continued for the duration of 1 year, in number and frequency according to clinical indication.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Providing informed consent prior to any specific study procedure
- •Female or male outpatient patients > 18 years
- •Have heart failure and left ventricular ejection fraction <= 40%, according to the ESC definition
- •Already on therapy with an angiotensin converting enzyme (ACE) inhibitor or sacubitril / valsartan, a beta-blocker and mineralocorticoid receptor antagonist (MRA) and be initiated for treatment with SGLT2i for therapy optimization
排除标准
- •Involvement in study planning and / or conducting (applies to both investigator staff and study site staff)
- •Age <18 years
- •For women only - ongoing pregnancy (confirmed with positive pregnancy test)
- •For women only - breastfeeding
- •Poor quality of echocardiographic images which compromises a correct speckle tracking analysis
- •Failure to sign informed consent.
- •Previous treatment with SGLT2i.
结局指标
主要结局
Predictors of remodeling and improvement in LV systolic and diastolic function
时间窗: 18 months
A univariate and multivariate logistic regression analysis will be performed to search for predictors of remodeling and improvement in LV systolic and diastolic function at 6 months, with particular attention to advanced echocardiography parameters.
次要结局
- Combined outcome 12 months from the third evaluation (18 months from the start of therapy) including death from cardiovascular causes, appropriate defibrillator discharge, hospitalizations or episodes of atrial fibrillation.(18 months)
研究者
Matteo Cameli
Professor
Azienda Ospedaliera Universitaria Senese