Background: The feasibility of spironolactone withdrawal in dilated cardiomyopathy patients with improved ejection fraction remains unknown. This study sought to determine whether spironolactone can be withdrawn safely in this circumstance.

Methods: Consecutive patients with idiopathic dilated cardiomyopathy and prescribed spironolactone at discharge were included in this prospective, observational cohort using the Risk Evaluation and Management in Heart Failure Trial (NCT02998788) database. Those patients who experienced an absolute left ventricular ejection fraction (LVEF) improvement ≥10% and a second measurement of LVEF >40% would choose whether to continue spironolactone therapy and be included in final analysis. The primary endpoint was dilated cardiomyopathy relapse within 12 months, defined as a more than 10% reduction in LVEF, a 15% or greater increase in LVESVi, a 2-fold rise in NT-proBNP, or clinical signs of heart failure.

Results: Seventy patients achieved an ejection fraction improvement and were included in the final analysis, of whom 30 chose to continue spironolactone and 40 decided to withdraw. In primary endpoint analysis, 23 (58%) patients from the withdrawal group and 4 (13%) patients from the continuation group relapsed (relative risk for relapse: 4.31; 95% CI: 1.67–11.11; p < 0.001). Patients from the withdrawal group experienced more symptom aggravation than the continuation group. No secondary safety endpoint was recorded. Improvements in cardiac structure parameters were no longer observed after spironolactone withdrawal, while improvements persisted in continuation group.

Conclusions: Most dilated cardiomyopathy patients with improved ejection fraction will relapse after spironolactone withdrawal. These results should be weighed before spironolactone withdrawal was attempted.

背景：在射血分数改善的扩张型心肌病患者中停用螺内酯的可行性仍然未知。本研究试图确定在这种情况下是否可以安全地停用螺内酯。

方法：使用心力衰竭试验的风险评估和管理 (NCT02998788) 数据库将连续患有特发性扩张型心肌病并在出院时服用螺内酯的患者纳入该前瞻性观察队列。那些左心室射血分数 (LVEF) 绝对改善≥10% 且第二次测量 LVEF >40% 的患者将选择是否继续螺内酯治疗并纳入最终分析。主要终点是扩张型心肌病在 12 个月内复发，定义为 LVEF 降低 10% 以上，LVESVi 增加 15% 或更多，NT-proBNP 增加 2 倍，或心力衰竭的临床体征。

结果：70 名患者射血分数改善并纳入最终分析，其中 30 名选择继续服用螺内酯，40 名决定退出。在主要终点分析中，停药组 23 名 (58%) 患者和继续治疗组 4 名 (13%) 患者复发（复发的相对风险：4.31；95% CI：1.67–11.11；磷< 0.001)。戒断组的患者比继续组的患者症状加重更多。没有记录到次要安全终点。停用螺内酯后不再观察到心脏结构参数的改善，而继续组的改善持续存在。

结论：大多数射血分数改善的扩张型心肌病患者在停用螺内酯后会复发。在尝试停用螺内酯之前，应权衡这些结果。