Empagliflozin in Heart Failure: Diuretic and Cardio-Renal Effects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- urine sodium concentrations via ion selective electrodes
研究概览
简要总结
The investigators propose a small pilot proof of concept study to not only prove the existence of, but also probe the mechanisms underlying cardio-renal effects of empagliflozin in patients with heart failure. The investigators propose a 50 patient randomized, double-blind, placebo-controlled crossover study with patients with stable HF, type II diabetes and an eGFR >45ml/min/1.73 m2 who are chronically receiving loop diuretics.
详细描述
Study Objectives
- Study the acute/short term effect and cardio-renal mechanisms of sodium-glucose cotransporter 2 (SGLT2) inhibition in patients with heart failure.
- Determine the effect of chronic combined SLLGT2 and loop diuretic exposure in patients with heart failure.
Primary Outcomes
- Aim 1 (Acute): Determine if acute SGLT2 inhibition will improve the natriuretic effect of a loop diuretic compared to placebo.
- Aim 2 (Chronic): Determine the effect of 14 days of SGLT2 inhibition on blood volume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Stable HF as defined by:
- •No hospitalization for >60 days
- •Stable HF medications for >=2 weeks, and stable diuretics for 4 weeks
- •Opinion of HF cardiologist that the patient is at their optimal volume status
- •Chronic daily oral loop diuretic dose >=20mg furosemide equivalents
- •Diagnosis of type II diabetes
- •Patient monitors blood glucose regularly at home
- •eGFR >=45 mL/min/1.73 m2
- •>=18 years old
排除标准
- •Active titration of chronic HF medications expected during the study period
- •Use of a non-loop diuretic, aside from an aldosterone antagonist (<=25mg spironolactone or <=50mg eplerenone)
- •Critical stenotic valvular disease, complex congenital heart disease, or prior heart transplant
- •History of diabetic ketoacidosis, "brittle" diabetes, and/or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 6 months
- •History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections
- •Anemia (defined as hemoglobin <8g/dL)
- •Pregnancy or breastfeeding
- •History of serious hypersensitivity
- •Participation in another trial with an investigational drug within the 30 days prior to informed consent
- •Use of another SGLT-2 inhibitor
- •Appears unlikely, or unable to participate in the required study procedures, as assessed by the study PI or research RN (ex: clinically-significant psychiatric, addictive, or neurological disease)
- •Inability to give written informed consent or follow study protocol
研究组 & 干预措施
Placebo, then empagliflozin
Patients are randomized upon enrollment to determine whether they take empagliflozin or the matched placebo during the first 2-week treatment phase of the study. All patients then undergo a 2-week "washout period" before crossing over to the alternate therapy.
干预措施: Empagliflozin (Drug)
Placebo, then empagliflozin
Patients are randomized upon enrollment to determine whether they take empagliflozin or the matched placebo during the first 2-week treatment phase of the study. All patients then undergo a 2-week "washout period" before crossing over to the alternate therapy.
干预措施: Placebo Oral Capsule (Drug)
Empagliflozin, then Placebo
Patients are randomized upon enrollment to determine whether they take empagliflozin or the matched placebo during the first 2-week treatment phase of the study. All patients then undergo a 2-week "washout period" before crossing over to the alternate therapy.
干预措施: Empagliflozin (Drug)
Empagliflozin, then Placebo
Patients are randomized upon enrollment to determine whether they take empagliflozin or the matched placebo during the first 2-week treatment phase of the study. All patients then undergo a 2-week "washout period" before crossing over to the alternate therapy.
干预措施: Placebo Oral Capsule (Drug)
结局指标
主要结局
urine sodium concentrations via ion selective electrodes
时间窗: 36 days
Determine if acute SGLT2 inhibition will improve the natriuretic effect of a loop diuretic compared to placebo. Measuring the natriuretic effect of a loop diuretic (placebo v acute SGLT2 inhibition) via urine sodium output.
次要结局
- blood volume(14 days)