Department of Pharmacy Practice, Lipscomb University College of Pharmacy, Nashville, TN; Department of Pharmacy, Vanderbilt University Medical Center, Nashville, TN.
Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN.
Am Heart J. 2021 Feb;232:116-124. doi: 10.1016/j.ahj.2020.10.071. Epub 2020 Nov 2.
Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, reduces cardiovascular death and worsening heart failure in patients with chronic heart failure and reduced ejection fraction. Early initiation during an acute heart failure (AHF) hospitalization may facilitate decongestion, improve natriuresis, and facilitate safe transition to a beneficial outpatient therapy for both diabetes and heart failure.
The objective is to assess the efficacy and safety of initiating dapagliflozin within the first 24 hours of hospitalization in patients with AHF compared to usual care.
DICTATE-AHF is a prospective, multicenter, open-label, randomized trial enrolling a planned 240 patients in the United States. Patients with type 2 diabetes hospitalized with hypervolemic AHF and an estimated glomerular filtration rate of at least 30 mL/min/1.73m are eligible for participation. Patients are randomly assigned 1:1 to dapagliflozin 10 mg once daily or structured usual care until day 5 or hospital discharge. Both treatment arms receive protocolized diuretic and insulin therapies. The primary endpoint is diuretic response expressed as the cumulative change in weight per cumulative loop diuretic dose in 40 mg intravenous furosemide equivalents. Secondary and exploratory endpoints include inpatient worsening AHF, 30-day hospital readmission for AHF or diabetic reasons, change in NT-proBNP, and measures of natriuresis. Safety endpoints include the incidence of hyper/hypoglycemia, ketoacidosis, worsening kidney function, hypovolemic hypotension, and inpatient mortality.
The DICTATE-AHF trial will establish the efficacy and safety of early initiation of dapagliflozin during AHF across both AHF and diabetic outcomes in patients with diabetes.
达格列净是一种钠-葡萄糖共转运蛋白 2 抑制剂，可降低射血分数降低的慢性心力衰竭患者的心血管死亡和心力衰竭恶化风险。在急性心力衰竭（AHF）住院期间早期开始使用，可能有助于利尿、增加钠排泄，并有助于安全过渡到对糖尿病和心力衰竭均有益的门诊治疗。
本研究旨在评估与常规治疗相比，在 AHF 住院的最初 24 小时内开始使用达格列净的疗效和安全性。
DICTATE-AHF 是一项前瞻性、多中心、开放标签、随机试验，计划在美国纳入 240 例患者。患有 2 型糖尿病且因充血性 AHF 住院且估计肾小球滤过率至少为 30 mL/min/1.73m 的患者有资格参加。患者按 1:1 随机分为达格列净 10 mg 每日 1 次或常规护理至第 5 天或出院。两个治疗组均接受方案化利尿剂和胰岛素治疗。主要终点是利尿剂反应，以 40 mg 静脉呋塞米等效物累积利尿剂剂量的累积体重变化来表示。次要和探索性终点包括住院期间心力衰竭恶化、30 天因心力衰竭或糖尿病原因再次住院、NT-proBNP 变化以及排钠量测量。安全性终点包括高血糖/低血糖、酮症酸中毒、肾功能恶化、低血容量性低血压和住院死亡率的发生率。
DICTATE-AHF 试验将确定在糖尿病患者中，在 AHF 和糖尿病结局方面，早期开始使用达格列净的疗效和安全性。
