The Hemodynamic Effects of Sodium-Glucose Co-Transporter 2 Inhibitors (SGLT2i) in Acute Decompensated Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change in Indirect Fick Cardiac Index
研究概览
简要总结
The main purpose of this study is to observe hemodynamic effects of initiating sodium-glucose co-transporter 2 inhibitors (SGLT2i) in patients admitted to the intensive care unit (ICU) with acute decompensated heart failure.
详细描述
The exact mechanism of cardiovascular benefit from SGLT2i continues to be the source of further research. The investigators hypothesize that heart failure patients with acute decompensated heart failure will similarly benefit from the SGLT2i-associated natriuresis and diuresis. This mechanism should improve invasive hemodynamics during an inpatient ICU stay.
This is a prospective, randomized controlled study to assess cardiac benefit of SGLT2i in 40 consecutive patients admitted to University of Chicago Cardiac Intensive Care Unit (CCU) Advanced Heart Failure Service. Subjects will be randomized 1:1 to one of two routine care arms: treatment with an SGLT2i [dapagliflozin 10 mg daily] or no SGLT2i. After randomization, your SGLT2i and heart failure care will be managed according to routine care, and the investigators will collect the subject's medical data. The patient's treating physician will be able to override randomization assignment if they determine that the assignment is not in the patient's best interest.
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
- None
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
- •Age > 18 years old
- •Heart Failure Reduced ejection fraction (HFrEF) of 40 or less
- •Estimated glomerular filtration rate (eGFR) > 30milliliters(ml)/minute(min)/1.73 meter(m)2
- •Admitted to CCU by advanced heart failure service for decompensated heart failure requiring continuous hemodynamic monitoring with a pulmonary artery catheter
排除标准
- •Diagnosis of type 1 diabetes mellitus
- •eGFR < 30ml/min/1.73m2
- •age < 18 years old
- •Jehovah's witnesses
- •Diagnosis of group 1 pulmonary arterial hypertension
- •Insulin requirement above standard low dose sliding scale
- •Patients with a history of diabetic ketoacidosis (DKA)
- •Allergies to SGLT2i medications
- •History of intolerance to SGLT2i medications
- •Patients listed for cardiac transplantation or on mechanical support
- •Pregnant or breastfeeding
研究组 & 干预措施
SGLT2i
Participants will be treated with a SGLT2i during their ICU stay. The SGLT2i and heart failure care will be managed according to routine care, and data will be collected from the participant's medical record.
干预措施: SGLT2i (Drug)
No SGLT2i
Participants will not be treated with a SGLT2i during their ICU stay. Heart failure care will be managed according to routine care, and data will be collected from the participant's medical record.
干预措施: No SGLT2i (Other)
结局指标
主要结局
Change in Indirect Fick Cardiac Index
时间窗: 4 days
Measured by pulmonary artery catheter
Change in Pulmonary Capillary Wedge Pressure (PCWP)
时间窗: 4 days
Measured by pulmonary artery catheter
次要结局
未报告次要终点