Hyun Junho, Lee Sang Eun, Lee Seung-Ah, Hong Jung Ae, Kim Min-Seok, Kim Jae-Joong
Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Int J Heart Fail. 2021 Jan 14;3(1):51-58. doi: 10.36628/ijhf.2020.0044. eCollection 2021 Jan.
It is unclear if guideline-directed medical therapy (GDMT) should be maintained in patients who have heart failure (HF) with improved ejection fraction (HFiEF). Of the medications recommended for HF, mineralocorticoid receptor antagonist (MRA) is associated with heterogeneous results and considerable adverse events. We wish to evaluate whether MRA withdrawal is safe or associated with deterioration of left ventricular ejection fraction (LVEF). We will select 60 patients with HFiEF of a New York Heart Association functional class I-II who are receiving GDMT and randomize them in a 1:1 fashion into 2 groups: one that will continue treatment and one that will have spironolactone administration withdrawn. All patients will receive standard medical therapy other than MRA. The primary outcome is the proportion of patients with declining LVEF ≥10%. Secondary outcomes include a change in LVEF, the estimated glomerular filtration rate, B-type natriuretic peptide or N-terminal pro-brain natriuretic peptide levels, and adverse clinical events, including death, re-hospitalization, or an emergency department visit for HF. This trial will provide important evidence on whether MRA in addition to other standard therapy, should be maintained or withdrawn in patients with HFiEF.
对于射血分数改善的心力衰竭（HFiEF）患者，是否应维持指南指导的药物治疗（GDMT）尚不清楚。在推荐用于心力衰竭的药物中，盐皮质激素受体拮抗剂（MRA）的结果存在异质性且有相当多的不良事件。我们希望评估停用MRA是否安全或是否与左心室射血分数（LVEF）恶化相关。我们将选择60例纽约心脏协会功能分级为I-II级的HFiEF患者，这些患者正在接受GDMT，并将他们以1:1的方式随机分为两组：一组继续治疗，另一组停用螺内酯。所有患者除MRA外均接受标准药物治疗。主要结局是LVEF下降≥10%的患者比例。次要结局包括LVEF的变化、估计肾小球滤过率、B型利钠肽或N末端脑钠肽前体水平，以及不良临床事件，包括死亡、再次住院或因心力衰竭到急诊科就诊。这项试验将为在HFiEF患者中除其他标准治疗外是否应维持或停用MRA提供重要证据。
