Low-dose digoxin in patients with heart failure with reduced or mildly reduced ejection fraction: a randomized controlled trial.

Earlier studies have suggested that low-dose digoxin might be beneficial, but evidence from rigorous randomized clinical trials is lacking.

早期研究表明，低剂量地高辛可能有益，但缺乏严格的随机临床试验的证据。

In this double-blind, placebo-controlledtrial (the DECISION trial), 1,001 patients with symptomatic chronic heart failure and a left ventricular ejection fraction of 50% or less were randomized to low-dose digoxin or placebo, with a target serum digoxin concentration of 0.5-0.9 ng ml-1.

在这项双盲、安慰剂对照试验（DECISION试验）中，1,001名有症状的慢性心力衰竭患者和左心室射血分数50%或以下的患者被随机分配到低剂量地高辛或安慰剂组，目标血清地高辛浓度为0.5-0.9 ng ml-1。

The mean age of the participants was 72 ± 9 years, 28% were women and 29% had atrial fibrillation.

参与者的平均年龄为72±9岁，其中28%为女性，29%有房颤。

The primary outcome was a composite of total worsening heart failure events, defined as total hospitalizations or total urgent hospital visits for worsening heart failure and cardiovascular mortality.

主要结果是心力衰竭恶化事件的总和，定义为因心力衰竭恶化导致的总住院次数或紧急医院就诊次数以及心血管死亡。

Over a median follow-up of 36.5 months, 238 primary-outcome events occurred in 131 of 500 patients in the digoxin group, and 291 primary-outcome events in 152 of 501 patients occurred in the placebo group (rate ratio 0.81; 95% confidence interval(CI) 0.61-1.07, P = 0.133).

在中位随访36.5个月期间，地高辛组500名患者中有131名发生了238起主要结果事件，而安慰剂组501名患者中有152名发生了291起主要结果事件（率比0.81；95%置信区间（CI）0.61-1.07，P = 0.133）。

The total number of worsening heart failure events was 155 and 203 in the digoxin and placebo groups, respectively (rate ratio 0.76, 95% CI 0.54-1.05) and cardiovascular mortality occurred in 83 patients (17%) and 88 (18%) in the digoxin and placebo groups, respectively (hazard ratio0.93, 95% CI 0.69-1.26).

心力衰竭恶化事件总数在地高辛组和安慰剂组分别为155例和203例（发生率比为0.76，95%置信区间为0.54-1.05），心血管死亡发生在地高辛组和安慰剂组分别为83例（17%）和88例（18%）（风险比为0.93，95%置信区间为0.69-1.26）。

Low-dose digoxin was generally well tolerated and safe, and results were similar between men and women.

低剂量地高辛通常耐受性良好且安全，男性和女性之间的结果相似。

The results of this trial indicate that in patients with heart failure and reduced or mildly reduced ejection fraction, low-dose digoxin did not significantly reduce the composite endpoint of total worsening heart failure events or cardiovascular mortality.

本试验结果显示，在心力衰竭且射血分数降低或轻度降低的患者中，低剂量地高辛并未显著降低心力衰竭恶化事件或心血管死亡的复合终点。

ClinicalTrials.gov registration: NCT03783429 .

ClinicalTrials.gov 注册号：NCT03783429。