Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Department of Cardiology, Meander Medisch Centrum, Amersfoort, The Netherlands.
Eur J Heart Fail. 2024 Oct;26(10):2223-2230. doi: 10.1002/ejhf.3428. Epub 2024 Aug 30.
Digoxin is the oldest drug in cardiovascular (CV) medicine, and one trial conducted >25 years ago showed a reduction in heart failure (HF) hospitalizations but no effect on mortality. However, later studies suggested that the dose of digoxin used in that trial (and other studies) may have been too high. The DECISION (Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands) trial will examine the efficacy and safety of low-dose digoxin in HF patients with reduced or mildly reduced left ventricular ejection fraction (LVEF) with a background of contemporary HF treatment.
The DECISION trial is a randomized, double-blind, parallel-group, placebo-controlled event-driven outcome trial which will investigate the efficacy and safety of low-dose digoxin in patients with chronic HF and LVEF <50%. Both patients with sinus rhythm and atrial fibrillation will be enrolled and will be randomized (1:1) to low-dose digoxin or matching placebo. To maintain a target serum digoxin concentration of 0.5-0.9 ng/ml, dose adjustments are made throughout follow-up based on serum digoxin measurements with dummy values for the placebo group. The primary endpoint is a composite of CV mortality and total HF hospitalizations or total urgent hospital visits for worsening HF, and all endpoints are adjudicated blindly by a Clinical Event Committee. The estimated sample size was 982 patients who will be followed for a median of 3 years, and in December 2023 enrolment was completed after 1002 patients.
The DECISION trial will provide important evidence regarding the effect of (low-dose) digoxin on CV mortality and total HF hospitalizations and urgent hospital visits when added to contemporary HF treatment of patients with reduced or mildly reduced LVEF.
ClinicalTrials.gov identifier: NCT03783429.
地高辛是心血管医学中最古老的药物，一项超过 25 年前进行的试验表明，它可以减少心力衰竭（HF）住院次数，但对死亡率没有影响。然而，后来的研究表明，该试验（和其他研究）中使用的地高辛剂量可能过高。DECISION（Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands）试验将研究低剂量地高辛在射血分数（LVEF）降低或轻度降低的 HF 患者中的疗效和安全性，这些患者有背景为当代 HF 治疗。
DECISION 试验是一项随机、双盲、平行组、安慰剂对照、事件驱动的结局试验，将研究低剂量地高辛在慢性 HF 和 LVEF<50%的患者中的疗效和安全性。窦性心律和心房颤动的患者都将被纳入，并按 1:1 随机分为低剂量地高辛或匹配的安慰剂组。为了维持目标血清地高辛浓度为 0.5-0.9ng/ml，根据血清地高辛测量值进行剂量调整，并为安慰剂组提供虚拟值。主要终点是心血管死亡率和总 HF 住院或因 HF 恶化而总紧急住院就诊的复合终点，所有终点均由临床事件委员会进行盲法裁决。估计样本量为 982 例患者，中位随访 3 年，2023 年 12 月完成了 1002 例患者的入组。
DECISION 试验将提供关于在射血分数降低或轻度降低的患者中添加当代 HF 治疗后，（低剂量）地高辛对心血管死亡率和总 HF 住院及紧急住院就诊的影响的重要证据。
ClinicalTrials.gov 标识符：NCT03783429。
