Sodium Glucose Co-Transporter 2 (SGLT2) Inhibition Improves Left Ventricular Function and Reduces Adverse Left-Ventricular Remodeling in High-Risk Patients with Microvascular Obstruction (MVO) Following ST-elevation Myocardial Infarction (STEMI).
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Change in LVEDVI
研究概览
简要总结
The purpose of the research is to determine whether a class of medication called SGLT2 inhibitor will improve the heart's function and reduce its enlargement after a heart attack. Participation in this study will involve taking this class of medication (or a placebo) once daily for six months, one cardiac magnetic resonance imaging (MRI) test during your initial hospitalization, follow-up phone calls at 1 and 3 months, and one cardiac MRI and clinic visit at six months. This is a single center study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Treatment will be blinded to the participant and investigator. Assignment of treatment arm will be managed by Abbott Northwestern Heart Hospital pharmacy.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with their first STEMI (>18 years) who underwent successful primary PCI and able to give informed consent
- •At least mild LV dysfunction (LVEF < 50%) on echocardiogram, cMRI or Left Ventriculargram following PCI
- •Infarct size that is > 10% of LV mass
- •The presence of MVO that is > 10% of infarct size
排除标准
- •Contraindication to cardiac MRI
- •Life expectancy < 1 year
- •Previous CABG or Valve Surgery
- •Previous STEMI
- •Pregnant or planning to become pregnant or lactating women
- •Cardiogenic shock (not resolved)
- •Atrial fibrillation or recurrent sustained ventricular arrhythmias (excluding PVCs)
- •GFR<30 ml/min/1.73m2 or end-stage renal disease on dialysis
- •Type 1 diabetes mellitus or history of diabetic ketoacidosis
- •Type I or II diabetes with insulin use
- •Prior intolerance of SGLT2 inhibitors
- •Current use of SGLT2 inhibitors (randomized patients only)
- •Contraindications to gadolinium
研究组 & 干预措施
Treatment Group
Treatment group will receive SGLT2 inhibitor in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.
干预措施: SGLT-2 inhibitors (Drug)
Placebo Group
Placebo Group will receive placebo in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in LVEDVI
时间窗: 6 Months
Change in LVEDVI at 6 months as measured by MRI.
Change in LVESVI
时间窗: 6 Months
Change in LVESVI at 6 months as measured by MRI.
次要结局
- Change in LVEF(6 months)
- MACE rates - including hospitalization for CHF, repeat revascularization, MI and death and ICD implantation(1 year)
- Change in LV mass(6 months)