The Potential Beneficial Effects of SGLT2 Inhibitors in Patients With Acute Decompensated Heart Failure During Ventilator Weaning: a Prospective Multicenter Cohort Study.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Composite of weaning failure, recurrent pulmonary edema, and cardiovascular/non-cardiovascular mortality.
研究概览
简要总结
This study will explore the potential benefits of sodium-glucose cotransporter 2 (SGLT2) inhibitors in preventing cardiac ischemia and cardiopulmonary edema in patients with acute decompensated heart failure during weaning from ventilators.
详细描述
Patients with acute decompensated HF will be open-label randomly assigned to be treated with or without SGLT2 inhibitors (either empagliflozin 10 mg once daily or dapagliflozin 10 mg once daily) 3 days before ventilator weaning in a ratio of 2:1. If the patients are allocated to SGLT2i treatment group, they will be further randomized equally to either empagliflozin- or dapagliflozin-treated group. A series of examination will be performed to detect weaning-induced cardiac ischemia and weaning-induced cardiopulmonary edema, including electrocardiography, chest X-ray, echocardiography, and biomarkers.
Echocardiography Transthoracic echocardiography (TTE) will be performed by a trained operator at several time points: (1) before SBT and SGLT2i initiation; (2) during SBT trial just after initiating SGLT2 inhibitor; (3) during SBT trial 3 days after initiation of SGLT2 inhibitor; (4) within 24 hrs after extubation; (5) 7-10 days after extubation; (6) 90±7 days after extubation.
Biomarkers NT-proBNP, plasma protein, high-sensitive cardiac troponin T, and hemoglobin level will be checked at several time points: (1) before spontaneous breathing trial (SBT), (2) during SBT trial (at least 10 mins after the initiation of SBT) just after initiating SGLT2 inhibitor; (3) during SBT (at least 10 mins after the initiation of SBT) trial 3 days after SGLT2 inhibitor; (4) within 24 hrs after extubation; (5) 7~10 days after extubation; (5) 90±7 days after extubation. We will also check arterial blood gas analyses at the end of SBT trial just after initiating SGLT2 inhibitor and 3 days after SGLT2 inhibitor.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥20 years
- •Currently hospitalized for the primary diagnosis of acute HF (de novo or decompensated chronic HF) in HFrEF patients (LVEF≤40%)
- •Meet the stabilization criteria:
- •A. Systolic BP ≥100mm Hg and no symptoms of hypotension in the preceding 6 hours B. No increase in i.v. diuretic dose for 6 hours prior to randomization C. No i.v. vasodilators including nitrates within the last 6 hours prior to randomization D. No i.v. inotropic drugs for 24 hours prior to randomization
- •Elevated N-terminal proB-type natriuretic peptide (NT-proBNP) or BNP:
- •A. Without atrial fibrillation (AF): NT-proBNP ≥1600 pg/mL or BNP ≥400 pg/mL B. With AF: NT-proBNP ≥2400 pg/mL or BNP ≥600 pg/mL
- •Patients were intubated for at least 24 hour with ventilator settings allowing to initiate the weaning process [SpO2 > 90% or PaO2/FiO2 ≥ 150 mmHg with a fraction of inspired oxygen (FiO2) ≤ 40% and a positive end-expiratory pressure (PEEP) ≤ 8 cmH2O].
排除标准
- •Decision to withdraw life support
- •Cardiogenic shock
- •Hospitalization for HF (HHF) triggered by acute myocardial infarction (AMI) or pulmonary embolism
- •Planned or previous (within 30 days) cardiovascular revascularization or major cardiac surgery/intervention/device implantation
- •Prior acute coronary syndrome, AMI, stroke or transient ischemic accident within 90 days
- •Estimated glomerular filtration rate (eGFR) of less than 30 ml per minute per 1.73 m2 of body-surface area
- •Type 1 diabetes mellitus
- •Poorly controlled type 2 diabetes mellitus (a glycated hemoglobin level above 10.5%)
- •Uncontrolled urinary tract infection
研究组 & 干预措施
empagliflozin 10mg
acute decompensated HF Patients 2：1,have 50 Patients control and 100 Patients randomly assigned empagliflozin or dapagliflozin ,3 days before ventilator weaning in a ratio of 1:1.empagliflozin 10 mg once daily
干预措施: SGLT2 inhibitor (Drug)
dapagliflozin 10mg
acute decompensated HF Patients 2：1,have 50 Patients control and 100 Patients randomly assigned empagliflozin or dapagliflozin ,3 days before ventilator weaning in a ratio of 2:1. dapagliflozin 10 mg once daily
干预措施: SGLT2 inhibitor (Drug)
结局指标
主要结局
Composite of weaning failure, recurrent pulmonary edema, and cardiovascular/non-cardiovascular mortality.
时间窗: 90 days
Weaning failure is defined that patient is reintubated within 7 days following extubation, irrespective of the use of noninvasive ventilation
次要结局
- Components of the primary endpoint(90 days)
- Diuretic response(after 15 and 30 days of treatment)
- Change in NT-proBNP level(over 30 days of treatment)
- Occurrence of chronic dialysis or renal transplant or significant, sustained reduction of estimated glomerular filtration rate(90 days)
- The therapeutic effect by different SGLT2i on components of the primary endpoint.(90 days)
研究者
National Taiwan University Clinical Trial Center
Chih Fan Yeh, MD, PhD
National Taiwan University Hospital