Early use of dapagliflozin in patients with acute myocardial infarction and reduced ejection fraction: the randomized ARMYDA-9 Dapagliflozin trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 5
- 主要终点
- Primary endpoint will be the infarct size, as assessed by cardiac MRI performed at 3-month follow-up, in the two arms. The adjudication of the primary outcome will be performed by a centralized, completely blinded analysis. Infarct size will be measured as percentage of left ventricular mass. Gadobutrol at the dose of 0.15 mmol/Kg will be used as contrast agent, with late gadolinium enhancement starting at 15 min onward. 5-SD will be utilized as method for quantification of infarct size.
研究概览
简要总结
The aim will be to study the potential cardioprotective effects (primarily the reduction of the infarct size) of an early use of the SGLT-2 inhibitor, to evaluate its safety (occurrence of a composite event including cardiovascular death, worsening of heart failure during hospitalization, myocardial re-infarction, stroke, or unplanned coronary revascularization) and side effects
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •STEMI regardless of the involved epicardial territories
- •Primary PCI <12 hours from symptom onset
- •TIMI coronary flow 0-1 at the time of primary PCI
- •Imaging evidence of new regional wall motion abnormality and LVEF ≤40% by ventriculography performed at the time of primary PCI or by trans-thoracic echocardiography performed as soon as possible within 12 hours from admission
- •Written informed consent to participate the study
排除标准
- •Cardiogenic shock on admission
- •Pregnancy or breastfeeding. For women of childbearing potential, any pregnancy status must be ascertained with a pregnancy test during the screening or randomization visit
- •Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or in the 5 half-lives of the study drug, whichever is longer
- •Symptomatic hypotension or blood pressure <90 mmHg
- •History of restrictive cardiomyopathy, constrictive pericarditis, hypertrophic cardiomyopathy or untreated severe heart valve disease
- •History of diabetic ketoacidosis, secondary diabetes or type 1 diabetes
- •History of heart failure with NYHA IV
- •Severe hepatic insufficiency
- •Active cancer
- •eGFR<30 ml/min
- •Hypersensitivity to the active substance or to any of the excipients
结局指标
主要结局
Primary endpoint will be the infarct size, as assessed by cardiac MRI performed at 3-month follow-up, in the two arms. The adjudication of the primary outcome will be performed by a centralized, completely blinded analysis. Infarct size will be measured as percentage of left ventricular mass. Gadobutrol at the dose of 0.15 mmol/Kg will be used as contrast agent, with late gadolinium enhancement starting at 15 min onward. 5-SD will be utilized as method for quantification of infarct size.
Primary endpoint will be the infarct size, as assessed by cardiac MRI performed at 3-month follow-up, in the two arms. The adjudication of the primary outcome will be performed by a centralized, completely blinded analysis. Infarct size will be measured as percentage of left ventricular mass. Gadobutrol at the dose of 0.15 mmol/Kg will be used as contrast agent, with late gadolinium enhancement starting at 15 min onward. 5-SD will be utilized as method for quantification of infarct size.
次要结局
- Clinical secondary outcomes: Time to occurrence of the composite outcome measure including cardiovascular death, worsening HF during index hospitalization or post-discharge HF requiring repeat hospitalization within 3 months. Occurrence of re-MI, stroke or unplanned coronary revascularization at 3 months. All-cause death at 3 months. Duration of in-hospital stay for the index event. Difference in the change of body weight from randomization to 3-month follow-up. Arterial pressure values during h
- Imaging secondary outcomes: Cardiac MRI, Transthoracic echocardiography
- Laboratory secondary outcomes: B-type natriuretic peptide, Renal function, EPO, Red blood cell
研究者
Clinical Trial Center
Scientific
Azienda Ospedaliero-Universitaria Maggiore Della Carita