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高钾血症高危心力衰竭患者的管理:心力衰竭中的CARE-HK注册研究。

Management of patients with heart failure at high risk of hyperkalaemia: The CARE-HK in HF registry.

作者信息

Greene Stephen J, Sauer Andrew J, Böhm Michael, Bozkurt Biykem, Butler Javed, Cleland John G F, Coats Andrew J S, Desai Nihar R, Grobbee Diederick E, Kelepouris Ellie, Pinto Fausto, Rosano Giuseppe, Donachie Victoria, Fabien Solenn, Waechter Sandra, Crespo-Leiro Maria G, Hülsmann Martin, Kempf Tibor, Pfister Otmar, Pouleur Anne-Catherine, Saxena Manish, Schulz Martin, Volterrani Maurizio, Anker Stefan D, Kosiborod Mikhail N

机构信息

Duke Clinical Research Institute, Durham, NC, USA.

Division of Cardiology, Duke University School of Medicine, Durham, NC, USA.

出版信息

Eur J Heart Fail. 2025 Aug 11. doi: 10.1002/ejhf.3800.

Abstract

AIMS

Patients with heart failure (HF) at high risk for hyperkalaemia are underrepresented in prospective HF registries. The CARE-HK in HF registry sought to characterize prospectively the clinical profile, management, and outcomes for patients with HF at high risk of hyperkalaemia.

METHODS AND RESULTS

CARE-HK in HF was a multinational prospective registry of outpatients with HF (regardless of left ventricular ejection fraction [LVEF]) treated with an angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker/angiotensin receptor-neprilysin inhibitor (ACEI/ARB/ARNI) and either receiving or potential candidate for a mineralocorticoid receptor antagonist (MRA). All patients were at increased risk of hyperkalaemia, defined as hyperkalaemia at baseline, prior hyperkalaemia, or estimated glomerular filtration rate (eGFR) <45 ml/min/1.73 m. Outcomes included frequency of hyperkalaemic events (defined by clinician report with associated potassium value), achievement of renin-angiotensin system inhibitor (RASi) optimization (defined as ≥50% target doses for ACEI/ARB/ARNI and MRA), medication changes following hyperkalaemic episodes, and clinical events. Overall, 2558 patients from 111 sites across nine countries were included. Median (25th-75th) age was 73 (65-80) years, 32% were women, 61% had LVEF ≤40%, and 40% had prior laboratory evidence of hyperkalaemia. Median baseline eGFR and serum potassium were 44 (33-60) ml/min/1.73 m and 5.0 (4.4-5.3) mEq/L, respectively. Over a median follow-up of 12.3 (9.4-18.1) months, 29% of patients had a hyperkalaemic event, and 7% had multiple events. In characterizing treatment prescribed for most of follow-up, 29% of patients received optimal RASi/MRA therapy, 69% received suboptimal RASi/MRA therapy, and 3% received no RASi/MRA. In the 30 days following the first hyperkalaemic event, RASi/MRA was down-titrated or discontinued in 3.6% of cases. Potassium binder use was low (patiromer 9.1%, sodium zirconium cyclosilicate 5.9%). Compared with patients without a hyperkalaemic event, patients experiencing a hyperkalaemic event had similar risk of all-cause mortality (hazard ratio [HR] 1.22, 95% confidence interval [CI] 0.92-1.62, p = 0.16) and a higher risk of subsequent hospitalization (HR 1.59, 95% CI 1.35-1.86, p < 0.001).

CONCLUSIONS

In this contemporary multinational prospective registry of patients with HF at high risk for hyperkalaemia, hyperkalaemic events were common but infrequently associated with RASi/MRA modification or potassium binder use. Fewer than one in three patients received optimal RASi/MRA therapy for the majority of follow-up, and hyperkalaemic events were associated with higher risk of adverse clinical outcomes.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov NCT04864795.

摘要

目的

高钾血症风险较高的心力衰竭(HF)患者在前瞻性HF登记研究中的代表性不足。HF领域的香港CARE登记研究旨在前瞻性地描述高钾血症高风险HF患者的临床特征、管理情况及预后。

方法与结果

香港CARE-HF研究是一项针对接受血管紧张素转换酶抑制剂/血管紧张素II受体阻滞剂/血管紧张素受体脑啡肽酶抑制剂(ACEI/ARB/ARNI)治疗且正在接受或可能适合接受盐皮质激素受体拮抗剂(MRA)治疗的HF门诊患者(无论左心室射血分数[LVEF]如何)的跨国前瞻性登记研究。所有患者的高钾血症风险均增加,定义为基线时高钾血症、既往有高钾血症或估计肾小球滤过率(eGFR)<45 ml/min/1.73 m²。结局包括高钾血症事件的发生频率(由临床医生报告并伴有相关钾值定义)、肾素-血管紧张素系统抑制剂(RASi)优化目标的达成情况(定义为ACEI/ARB/ARNI和MRA达到≥50%的目标剂量)、高钾血症发作后的药物调整以及临床事件。总体而言,纳入了来自9个国家111个研究点的2558例患者。中位(第25-75百分位数)年龄为73(65-80)岁,32%为女性,61%的患者LVEF≤40%,40%的患者既往有高钾血症的实验室证据。基线eGFR和血清钾的中位数分别为44(33-60)ml/min/1.73 m²和5.0(4.4-5.3)mEq/L。在中位随访12.3(9.4-18.1)个月期间,29%的患者发生了高钾血症事件,7%的患者发生了多次事件。在描述大多数随访期间所开的治疗方案时,29%的患者接受了最佳RASi/MRA治疗,69%的患者接受了次优RASi/MRA治疗,3%的患者未接受RASi/MRA治疗。在首次高钾血症事件后的30天内,3.6%的病例中RASi/MRA被减量或停用。钾结合剂的使用率较低(帕替罗姆9.1%,环硅酸锆钠5.9%)。与未发生高钾血症事件的患者相比,发生高钾血症事件的患者全因死亡风险相似(风险比[HR] 1.22,95%置信区间[CI] 0.92-1.62,p = 0.16),但随后住院的风险更高(HR 1.59,95% CI 1.35-1.86,p < 0.001)。

结论

在这项针对高钾血症高风险HF患者的当代跨国前瞻性登记研究中,高钾血症事件很常见,但很少与RASi/MRA调整或钾结合剂的使用相关。在大多数随访期间,不到三分之一的患者接受了最佳RASi/MRA治疗,且高钾血症事件与不良临床结局的较高风险相关。

临床试验注册

ClinicalTrials.gov NCT04864795。

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