Empagliflozin for Patients With Acutely Decompensated Congestive Heart Failure, Diuretic Resistance, and Moderate to Advanced Chronic Kidney Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Diuretic effect of empagliflozin in association with furosemide
研究概览
简要总结
The objective is to study in a prospective, interventional, single arm, cohort study the potential synergistic diuretic effect of empagliflozin, in addition to furosemide, in hypervolemic patients admitted with acutely decompensated heart failure and diuretic resistance at the McGill University Health Centre (MUHC).
The investigators hypothesize that the sodium-glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin will enhance the diuretic effect of furosemide in patients with acutely decompensated heart failure, moderate to advanced chronic kidney disease, and underlying diuretic resistance, as identified by the three-hour urine output post diuretic administration on the first day of the study, compared with furosemide alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •(all have to apply) :
- •moderate to advanced CKD, defined as an eGFR <45 ml/min/1.73m2; The average creatinine values over the last 12 months will be used to calculate baseline eGFR.
- •acutely decompensated heart failure, defined as dyspnea at rest or with minimal physical activity, associated with at least one clinical sign of congestion and at least one objective measure of heart failure (pulmonary-capillary wedge pressure >20 mm Hg or evidence of pulmonary congestion on chest radiography or brain natriuretic peptide (BNP) level ≥400 pg/ml or N-terminal pro-BNP level ≥1000 pg/ml);
- •evidence of inadequate response to loop diuretics, defined as a urine output < 1000 ml/24h or a weight loss < 1kg /24h. For patients who have not received loop diuretics, a furosemide stress test can be conducted.
- •stable hemodynamics, defined as systolic blood pressure >90 mmHg and/or mean arterial pressure >65 mmHg in the absence of intravenous norepinephrine or epinephrine in the last 24 hours.
排除标准
- •new use of a non-loop diuretic other than an MRA
- •history of type 1 diabetes mellitus
- •euglycemic diabetic ketoacidosis
- •liver disease defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening
- •known hypersensitivity to SGLT-2 inhibitors
- •use within the last 48 h of an SGLT-2 inhibitor or a combined SGLT-1 and SGLT-2 inhibitor
- •maintenance dialysis or need for emergent renal replacement therapy
- •gastrointestinal surgery or gastrointestinal disorder that could interfere with trial medication absorption
- •recurrent severe genital or urinary tract infection
- •pregnancy or breastfeeding
- •any other clinical condition that would jeopardize patient safety while participating in this trial
- •Patients with an acute rise in creatinine levels (acute cardiorenal syndrome) upon presentation will not be excluded.
研究组 & 干预措施
Patients with diuretic resistance
干预措施: Empagliflozin 25 MG (Drug)
结局指标
主要结局
Diuretic effect of empagliflozin in association with furosemide
时间窗: Day 1
Three-hour urine output post empagliflozin-furosemide administration, compared with furosemide alone
次要结局
- Fractional excretion of sodium in the urine(Day 1)
- Total urine sodium output(Day 1-5)
- Electrolyte abnormalities - Sodium(Day 1-5)
- Electrolyte abnormalities - Potassium(Day 1-5)
- Changes in volume status(Day 1-5)
- Incidence of AKI(Day 1-5)
- Electrolyte abnormalities - Magnesium(Day 1-5)
研究者
Thomas Mavrakanas
Assistant Professor, Junior Scientist
McGill University Health Centre/Research Institute of the McGill University Health Centre