BACKGROUND The necessity of neurohumoral blockers in patients with heart failure who demonstrate normalized ejection fractions after cardiac resynchronization therapy remains unclear. OBJECTIVES The aim of this study was to investigate the feasibility and safety of neurohumoral blocker withdrawal in patients with normalized ejection fractions after cardiac resynchronization therapy. METHODS In this prospective, open-label, randomized controlled pilot trial with a 2 × 2 factorial design, subjects were randomized to withdrawal of renin-angiotensin-aldosterone system inhibitors and/or beta-blockers versus continuation of treatment. The primary endpoint was a recurrence of negative remodeling, defined as an increase in left ventricular end-systolic volume index of >15% at 24 months. The secondary endpoint was a composite safety endpoint of all-cause mortality, heart failure-related hospitalizations, and incidence of sustained ventricular arrhythmias at 24 months. RESULTS Eighty subjects were consecutively enrolled and randomized among 4 groups (continuation of neurohumoral blocker therapy, n = 20; withdrawal of renin-angiotensin-aldosterone system inhibitors, n = 20; withdrawal of beta-blockers, n = 20; and withdrawal of renin-angiotensin-aldosterone system inhibitors and beta-blockers, n = 20). Of the 80 subjects, 6 (7.5%) met the primary and 4 (5%) the secondary endpoint. However, re-initiation of neurohumoral blockers occurred in 17 subjects because of hypertension or supraventricular arrhythmias. CONCLUSIONS The incidence of the primary and secondary endpoints over a follow-up period of 2 years was low in both the control group and in the groups in which neurohumoral blockers were discontinued. However, neurohumoral blocker withdrawal was hampered by cardiac comorbidities. (Systematic Withdrawal of Neurohumoral Blocker Therapy in Optimally Responding CRT Patients [STOP-CRT]; NCT02200822).

中文翻译：

---

心脏再同步治疗后神经体液阻滞的解除

背景 对于心脏再同步治疗后射血分数正常的心力衰竭患者，神经体液阻滞剂的必要性仍不清楚。目的 本研究的目的是调查心脏再同步治疗后射血分数正常的患者停用神经体液阻滞剂的可行性和安全性。方法 在这项采用 2 × 2 析因设计的前瞻性、开放标签、随机对照试验性试验中，受试者被随机分配至停用肾素-血管紧张素-醛固酮系统抑制剂和/或 β-受体阻滞剂组与继续治疗组。主要终点是负重构的复发，定义为 24 个月时左心室收缩末期容积指数增加 >15%。次要终点是全因死亡率、心力衰竭相关住院治疗和 24 个月时持续室性心律失常发生率的复合安全终点。结果 80 名受试者连续入组并随机分为 4 组（继续神经体液阻滞剂治疗，n = 20；停用肾素-血管紧张素-醛固酮系统抑制剂，n = 20；停用 β 受体阻滞剂，n = 20；停用肾素-血管紧张素-醛固酮系统抑制剂和β-受体阻滞剂，n = 20)。在 80 名受试者中，6 名 (7.5%) 达到主要终点，4 名 (5%) 达到次要终点。然而，由于高血压或室上性心律失常，17 名受试者重新开始使用神经体液阻滞剂。结论 在 2 年的随访期内，主要和次要终点的发生率在对照组和停用神经体液阻滞剂的组中均较低。然而，神经体液阻滞剂的停用受到心脏合并症的阻碍。（在最佳反应 CRT 患者中系统性停用神经体液阻滞剂治疗 [STOP-CRT]；NCT02200822）。