JACC. Heart failure最新文献

英文中文

The Role of Sodium Zirconium Cyclosilicate in Optimizing Heart Failure Therapy 环硅酸锆钠在优化心衰治疗中的作用

IF 10.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Heart failure

Pub Date : 2024-10-01 DOI: 10.1016/j.jchf.2024.06.004

Amina Rakisheva MD, PhD

引用次数: 0

Sacubitril/Valsartan in Patients With Heart Failure and Deterioration in eGFR to <30 mL/min/1.73 m2 萨库比特利/缬沙坦治疗心力衰竭且 eGFR 下降至 2.0 的患者

IF 10.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Heart failure

Pub Date : 2024-10-01 DOI: 10.1016/j.jchf.2024.03.014

Background

Sacubitril/valsartan is a foundational therapy for patients with heart failure. Although current U.S. Food and Drug Administration labeling does not provide guidance regarding initiation or continuation of sacubitril/valsartan in patients with worsening kidney function, guidelines identify estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² as a contraindication to therapy.

Objectives

This study aims to assess the safety and efficacy of continuing sacubitril/valsartan in patients with deterioration of kidney function below an eGFR of 30 mL/min/1.73 m².

Methods

The association between a deterioration in eGFR <30 mL/min/1.73 m², efficacy and safety outcomes, and treatment with sacubitril/valsartan vs renin-angiotensin system inhibitor were evaluated using time updated Cox models in a post hoc parallel trial analyses of PARADIGM-HF and PARAGON-HF.

Results

Among 8,346 randomized patients in PARADIGM-HF and 4,746 in PARAGON-HF, 691 (8.3%) and 613 (12.9%), respectively, had an eGFR <30 mL/min/1.73 m² at least once in follow-up. Patients experiencing such deterioration were at higher risk of the primary outcome in both PARADIGM-HF and PARAGON-HF. However, the incidence of the primary outcome remained lower with sacubitril/valsartan vs renin-angiotensin system inhibitor, regardless of deterioration in kidney function in both PARADIGM-HF (P_interaction = 0.50) and PARAGON-HF (P_interaction = 0.64). Rates of key safety outcomes were higher among patients experiencing eGFR deterioration; however, rates were similar between treatment groups including among those who remained on treatment.

Conclusions

Patients experiencing deterioration of kidney function to a value below eGFR 30 mL/min/1.73 m² faced high risk of cardiovascular and kidney disease outcomes. Continuation of sacubitril/valsartan was associated with persistent clinical benefit and no incremental safety risk. These data support continuation of sacubitril/valsartan for heart failure treatment even when eGFR declines below this threshold (PARADIGM-HF [Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure], NCT01035255; and PARAGON-HF [Prospective Comparison of ARNI with ARB Global Outcomes in HF with Preserved Ejection Fraction], NCT01920711)

背景介绍沙库比特利/缬沙坦是心力衰竭患者的基础治疗药物。尽管目前美国食品和药物管理局的标签并未就肾功能恶化患者开始或继续使用沙库比特利/缬沙坦提供指导，但指南将估计肾小球滤过率（eGFR）2列为治疗禁忌症：本研究旨在评估肾功能恶化、eGFR 低于 30 mL/min/1.73 m2 的患者继续服用沙库比妥/缬沙坦的安全性和有效性：在对PARADIGM-HF和PARAGON-HF进行的一项事后平行试验分析中，使用时间更新的Cox模型评估了eGFR 2恶化、疗效和安全性结果与使用沙库比特利/缬沙坦与肾素-血管紧张素系统抑制剂治疗之间的关系：在 PARADIGM-HF 的 8346 名随机患者和 PARAGON-HF 的 4746 名随机患者中，分别有 691 人（8.3%）和 613 人（12.9%）在随访期间至少一次出现 eGFR 2。在 PARADIGM-HF 和 PARAGON-HF 中，出现这种恶化的患者发生主要结局的风险较高。然而，在PARADIGM-HF（Pinteraction = 0.50）和PARAGON-HF（Pinteraction = 0.64）中，无论肾功能是否恶化，使用沙库比曲/缬沙坦与肾素-血管紧张素系统抑制剂相比，主要结局的发生率仍然较低。eGFR 恶化患者的主要安全性结果发生率较高；然而，各治疗组之间的发生率相似，包括仍在接受治疗的患者：结论：肾功能恶化至eGFR 30 mL/min/1.73 m2以下的患者面临心血管和肾脏疾病结局的高风险。继续服用沙库比特利/缬沙坦可带来持续的临床获益，且不会增加安全性风险。这些数据支持在 eGFR 下降到这一阈值以下时继续使用沙库比特利/缬沙坦治疗心衰（PARADIGM-HF [前瞻性比较 ARNI 与 ACEI 以确定对心衰患者总体死亡率和发病率的影响]，NCT01035255；以及 PARAGON-HF [前瞻性比较 ARNI 与 ARB 对射血分数保留的心衰患者的总体疗效]，NCT01920711）。

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引用次数: 0

Randomized Trial of Cholesterol Lowering With Evolocumab for Cardiac Allograft Vasculopathy in Heart Transplant Recipients 用 Evolocumab 降低胆固醇治疗心脏移植受者心脏移植物血管病的随机试验。

IF 10.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Heart failure

Pub Date : 2024-10-01 DOI: 10.1016/j.jchf.2024.04.026

Background

Cardiac allograft vasculopathy is characterized by increased coronary intimal thickness and is a leading cause of death in heart transplant (HTx) recipients despite the routine use of statins. The experience with inhibitors of proprotein convertase subtilisin-kexin type 9 in HTx recipients is limited. Our hypothesis was that lowering cholesterol with the proprotein convertase subtilisin–kexin type 9inhibitor evolocumab would reduce coronary intimal thickness in these patients without compromising safety.

Objectives

This double blind, randomized trial was conducted to test whether evolocumab reduces the burden of cardiac allograft vasculopathy.

Methods

Patients who had received a cardiac allograft at 1 of the Nordic transplant centers within the prior 4 to 8 weeks were randomized to monthly subcutaneous injections of evolocumab 420 mg or matching placebo. The primary endpoint was the baseline-adjusted maximal intimal thickness as measured by intracoronary ultrasound after 12 months’ treatment.

Results

The trial enrolled 128 patients between June 2019 and May 2022. Matched pairs of coronary ultrasound images were available for 56 patients assigned to evolocumab and 54 patients assigned to placebo. At 12 months, the adjusted mean difference in the maximal intimal thickness between the 2 arms was 0.017 mm (95% CI: −0.006 to 0.040; P = 0.14). The mean reduction in low-density lipoprotein cholesterol with evolocumab compared with placebo was 1.11 mmol/L (95% CI: 0.86-1.37 mmol/L). The use of evolocumab was not associated with an increase in adverse events.

Conclusions

Twelve months of treatment with evolocumab substantially reduced low-density lipoprotein cholesterol but did not reduce maximal coronary intimal thickness in HTx recipients. (Cholesterol Lowering With EVOLocumab to Prevent Cardiac Allograft Vasculopathy in De-novo Heart Transplant Recipients [EVOLVD]; NCT03734211)

背景：心脏移植血管病变的特点是冠状动脉内膜厚度增加，尽管他汀类药物已被常规使用，但它仍是心脏移植（HTx）受者死亡的主要原因。在心脏移植受者中使用9型枯草蛋白酶抑制剂的经验有限。我们的假设是，在不影响安全性的前提下，使用9型丙蛋白转化酶枯草酶-kexin抑制剂evolocumab降低胆固醇可减少这些患者的冠状动脉内膜厚度：这项双盲、随机试验旨在检验 evolocumab 是否能减轻心脏同种异体移植血管病变的负担：方法：在北欧移植中心接受过心脏同种异体移植手术的患者在4至8周内随机接受每月皮下注射420毫克evolocumab或相应安慰剂。主要终点是治疗12个月后通过冠状动脉内超声测量的基线调整后最大内膜厚度：该试验在2019年6月至2022年5月期间招募了128名患者。56名患者接受了evolocumab治疗，54名患者接受了安慰剂治疗。12个月时，两组患者最大内膜厚度的调整后平均差异为0.017毫米（95% CI：-0.006至0.040；P = 0.14）。与安慰剂相比，使用 evolocumab 后低密度脂蛋白胆固醇的平均降幅为 1.11 mmol/L（95% CI：0.86-1.37 mmol/L）。使用 evolocumab 与不良事件增加无关：结论：使用 evolocumab 治疗 12 个月后，低密度脂蛋白胆固醇大幅降低，但并未减少 HTx 受试者的最大冠状动脉内膜厚度。(使用 EVOLocumab 降低胆固醇以预防心脏异体移植受者的心脏血管病变 [EVOLVD]；NCT03734211）。

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引用次数: 0

Sodium Zirconium Cyclosilicate in HFrEF and Hyperkalemia 环硅酸锆钠治疗高频肾衰竭和高钾血症：REALIZE-K 设计和基线特征

IF 10.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Heart failure

Pub Date : 2024-10-01 DOI: 10.1016/j.jchf.2024.05.003

Background

Mineralocorticoid receptor antagonists (MRAs) improve outcomes in patients with heart failure and reduced ejection fraction (HFrEF). However, MRAs are often underused because of hyperkalemia concerns.

Objectives

The purpose of this study was to assess whether sodium zirconium cyclosilicate (SZC), a nonabsorbed crystal that traps and rapidly lowers potassium, enables MRA use in patients with HFrEF and prevalent hyperkalemia (or at high risk).

Methods

REALIZE-K is a prospective, double-blind, placebo-controlled trial in patients with HFrEF (NYHA functional class II-IV; left ventricular ejection fraction ≤40%), optimal therapy (except MRA), and prevalent hyperkalemia (or at high risk). During the open-label run-in, all participants underwent protocol-mandated spironolactone titration (target: 50 mg daily); those with prevalent (cohort 1) or incident (cohort 2) hyperkalemia during titration started SZC. Participants achieving normokalemia while on spironolactone ≥25 mg daily were randomized to continuing SZC or matching placebo for 6 months. The primary composite endpoint was proportion of participants with optimal response (normokalemia, on spironolactone ≥25 mg daily, no rescue for hyperkalemia [months 1-6]).

Results

Of 365 patients (run-in), 202 were randomized. Baseline characteristics included mean age 70 years, prevalent comorbidities (78% estimated glomerular filtration rate <60 mL/min/1.73 m², 38% atrial fibrillation/flutter), high N-terminal pro B-type natriuretic peptide (median 1,136 pg/mL), and high HFrEF therapy use (64% sacubitril/valsartan, 96% beta-blocker, 42% sodium glucose co-transporter 2 inhibitor). At randomization, 78% were receiving spironolactone 50 mg daily.

Conclusions

REALIZE-K is the first trial to evaluate whether SZC can enable rapid and safe MRA optimization and long-term continuation in patients with HFrEF and prevalent/high risk of hyperkalemia. (Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients with Symptomatic HFrEF Receiving Spironolactone [REALIZE-K]; NCT04676646)

矿物皮质激素受体拮抗剂（MRAs）可改善射血分数降低型心力衰竭（HFrEF）患者的预后。然而，由于存在高钾血症问题，MRA 通常未得到充分利用。为了评估环硅酸锆钠（SZC）这种能捕获并快速降低血钾的非吸收晶体是否能让高钾血症（或高风险）患者使用 MRA。REALIZE-K 是一项前瞻性、双盲、安慰剂对照试验，适用于 HFrEF（NYHA 功能分级 II/IV；左心室射血分数≤40%）、接受过最佳治疗（MRA 除外）和高钾血症流行（或高风险）的患者。在开放标签试运行期间，所有参与者都接受了方案规定的螺内酯滴定（目标值：每天 50 毫克）；在滴定过程中出现高钾血症（队列 1）或偶发高钾血症（队列 2）的参与者开始服用 SZC。每天服用螺内酯≥25毫克时达到正常血钾的参与者被随机分配到继续服用SZC或匹配的安慰剂，为期6个月。主要的复合终点是获得最佳应答（正常血钾、每天服用螺内酯≥25毫克、高血钾无需抢救[1-6个月]）的参与者比例。在 365 名患者（试验期）中，有 202 人接受了随机治疗。基线特征包括平均年龄 70 岁、普遍的合并症（78% 的估计肾小球滤过率<60 mL/min/1.73 m，37% 的心房颤动）、高 N 末端前 B 型钠尿肽（中位数 1,136 pg/mL）和高 HFrEF 治疗（64% 使用沙库比曲利/缬沙坦，96% 使用β-受体阻滞剂，42% 使用钠葡萄糖协同转运体 2 抑制剂）。在随机化时，75% 的患者每天服用 50 毫克螺内酯。REALIZE-K 是首个评估 SZC 是否能快速、安全地优化 MRA 并使高钾血症流行/高危患者长期服药的试验。(评估 SZC 对接受螺内酯治疗的症状性 HFrEF 患者高钾血症管理的有效性和安全性的研究；）。

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引用次数: 0

Beyond Remodeling 超越重塑：白细胞介素-1阻断作为预防心肌梗死后心力衰竭的治疗策略。

IF 10.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Heart failure

Pub Date : 2024-10-01 DOI: 10.1016/j.jchf.2024.07.016

Michele Golino MD, PhD , Matteo Morello MD

引用次数: 0

Full Issue PDF 全期 PDF

IF 10.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Heart failure

Pub Date : 2024-10-01 DOI: 10.1016/S2213-1779(24)00640-1

引用次数: 0

Simplifying Treatment of Congestion 简化充血治疗：序贯肾小球阻断术的利尿反应与射血分数无关。

IF 10.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Heart failure

Pub Date : 2024-10-01 DOI: 10.1016/j.jchf.2024.05.024

Eva M. Boorsma PhD , Kieran F. Docherty PhD , Ross T. Campbell PhD

引用次数: 0

Obesity, Challenges, and Weight-Loss Strategies for Patients With Ventricular Assist Devices 心室辅助装置患者的肥胖、挑战和减肥策略。

IF 10.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Heart failure

Pub Date : 2024-10-01 DOI: 10.1016/j.jchf.2024.04.006

For adults with advanced heart failure, class II/III obesity (body mass index ≥35 kg/m²) represents major challenges, and it is even considered a contraindication for heart transplantation (HT) at many centers. This has led to growing interest in preventing and treating obesity to help patients with advanced heart failure become HT candidates. Among all weight-loss strategies, bariatric surgery (BSx) has the greatest weight loss efficacy and has shown value in enabling select patients with left ventricular assist devices (LVADs) and obesity to lose sufficient weight to access HT. Nevertheless, both BSx and antiobesity medications warrant caution in the LVAD population. In this review, the authors describe and interpret the available published reports on the impact of obesity and weight-loss strategies for patients with LVADs from general and HT candidacy standpoints. The authors also provide an overview of the journey of LVAD recipients who undergo BSx and review major aspects of perioperative protocols.

对于晚期心力衰竭的成人患者来说，II/III 级肥胖（体重指数≥35 kg/m2）是一项重大挑战，在许多中心甚至被视为心脏移植（HT）的禁忌症。因此，人们对预防和治疗肥胖症以帮助晚期心衰患者成为心脏移植候选者的兴趣与日俱增。在所有减重策略中，减肥手术（BSx）的减重效果最好，并已显示出其价值，它能使部分患有左心室辅助装置（LVAD）和肥胖症的患者减掉足够的体重，从而获得心脏移植的机会。然而，在 LVAD 患者中，BSx 和抗肥胖药物都需要谨慎使用。在这篇综述中，作者从一般和 HT 候选者的角度描述并解释了已发表的有关肥胖和减肥策略对 LVAD 患者影响的报告。作者还概述了接受 BSx 手术的 LVAD 患者的心路历程，并回顾了围手术期方案的主要方面。

引用次数: 0

Distinct Comorbidity Clusters in Patients With Acute Heart Failure 急性心力衰竭患者的不同合并症群：来自 RELAX-AHF-2 的数据。

IF 10.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Heart failure

Pub Date : 2024-10-01 DOI: 10.1016/j.jchf.2024.04.028

Background

Multimorbidity frequently occurs in patients with acute heart failure (AHF). The co-occurrence of comorbidities often follows specific patterns.

Objectives

This study investigated multimorbidity subtypes and their associations with clinical outcomes.

Methods

From the prospective RELAX-AHF-2 (Relaxin for the Treatment of Acute Heart Failure-2) trial, 6,545 patients (26% with HF with preserved ejection fraction, defined as LVEF ≥50%) were classified into multimorbidity groups using latent class analysis. The association between subgroups and clinical outcomes was examined. Validation of these findings was conducted in the RELAX-AHF trial, which comprised 1,161 patients.

Results

Five distinct multimorbidity groups emerged: 1) diabetes and chronic kidney disease (CKD) (often male, high prevalence of CKD and diabetes mellitus); 2) ischemic (ischemic HF); 3) elderly/atrial fibrillation (AF) (oldest, high prevalence of AF); 4) metabolic (obese, hypertensive, more often HF with preserved ejection fraction); and 5) young (fewest comorbidities). After adjusting for confounders, patients in the diabetes and CKD (HR: 1.80; 95% CI: 1.50-2.20), elderly/AF (HR: 1.42; 95% CI: 1.20-1.70), and metabolic (HR: 1.40; 95% CI: 1.20-1.80) groups had higher rates of the composite outcome than patients in the young group, primarily driven by differences in rehospitalization. Treatment allocation (placebo or serelaxin) modified these associations (P_interaction <0.001). Serelaxin-treated patients in the young group were associated with a lower risk for all-cause mortality (HR: 0.59; 95% CI: 0.40-0.90). Similarly, patients from the RELAX-AHF trial clustered in 5 multimorbidity groups. The clinical characteristics and associations with outcomes could also be validated.

Conclusions

Comorbidities naturally clustered into 5 mutually exclusive groups in RELAX-AHF-2, showing variations in clinical outcomes. These data emphasize that the specific combination of comorbidities can influence adverse outcomes and treatment responses in patients with AHF.

背景：急性心力衰竭（AHF）患者常合并多种疾病。合并症的共存往往遵循特定的模式：本研究调查了多病亚型及其与临床结果的关系：方法：在前瞻性的 RELAX-AHF-2（Relaxin for the Treatment of Acute Heart Failure-2，松弛素治疗急性心力衰竭-2）试验中，采用潜类分析法将 6545 名患者（其中 26% 为射血分数保留型心力衰竭患者，定义为 LVEF ≥50%）分为多病群组。研究了亚组与临床结果之间的关联。这些研究结果在由 1,161 名患者组成的 RELAX-AHF 试验中进行了验证：出现了五个不同的多病分组：1）糖尿病和慢性肾脏病（CKD）（通常为男性，CKD和糖尿病发病率高）；2）缺血性（缺血性心房颤动）；3）老年/房颤（AF）（年龄最大，房颤发病率高）；4）代谢性（肥胖、高血压，多为射血分数保留的心房颤动）；5）年轻（合并症最少）。在对混杂因素进行调整后，糖尿病和慢性肾脏病组（HR：1.80；95% CI：1.50-2.20）、老年/房颤组（HR：1.42；95% CI：1.20-1.70）和代谢组（HR：1.40；95% CI：1.20-1.80）患者的综合结果发生率高于年轻组患者，主要原因是再住院率的差异。治疗分配（安慰剂或丝裂霉素）改变了这些关联（Pinteraction结论）：在RELAX-AHF-2中，合并症自然地分为5个相互排斥的组别，并显示出不同的临床结果。这些数据强调，合并症的特定组合会影响急性重症肌无力患者的不良预后和治疗反应。

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引用次数: 0

Sacubitril/Valsartan in Heart Failure and Deterioration in eGFR 萨库比特利/缬沙坦治疗心力衰竭和 eGFR 恶化：慢而稳，赢在起跑线上。

IF 10.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Heart failure

Pub Date : 2024-10-01 DOI: 10.1016/j.jchf.2024.07.010

John L. Jefferies MD, MBA, MPH

引用次数: 0

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