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PRospective evaluation of the European Society of Cardiology 0/1h-algorithm`s safety and efficacy for triage of patients with suspected myocardial infarction (PRESC1SE-MI): Rationale and design of a prospective international multicenter stepped-wedge cluster randomized controlled trial 欧洲心脏病学会0/1h算法对疑似心肌梗死患者分诊的安全性和有效性的前瞻性评价(PRESC1SE-MI):一项前瞻性国际多中心楔形步进聚类随机对照试验的基本原理和设计。
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-31 DOI: 10.1016/j.ahj.2025.107299
Jasper Boeddinghaus MD , Paolo Bima MD , Luca Crisanti MD , Dagmar I Keller MD , Ksenija Slankamenac MD PhD , Michael Christ MD , Philipp Schuetz MD , Andrea Wiencierz PhD , Ivo Strebel PhD , Julia Reinhardt PhD , Iryna Vyshnevska MD , Tzu-Ying Tsao MSc , Felix Mahfoud MD , Maria Pia Ruggieri MD , Stephan Steuer MD , Òscar Miró MD , Veli-Pekka Harjola MD , Fulvio Morello MD PhD , Peiman Nazerian MD , Dominik Roth MD PhD , John Parissis MD

Background

International practice guidelines recommend the more rapid European Society of Cardiology (ESC) 0/1h-algorithm for the triage of patients with suspected myocardial infarction (MI) as the preferred option and consider the ESC 0/3h-algorithm as an alternative. However, many centers worldwide have not yet adopted the ESC 0/1h-algorithm in clinical practice due to uncertainty which approach best balances safety and efficacy.

Methods

PRESC1SE-MI (PRospective Evaluation of the European Society of Cardiology 0/1h-algorithm`s Safety and Efficacy for Triage of Patients with Suspected Myocardial Infarction) is an international, investigator-initiated multicenter, stepped-wedge, cluster randomized controlled trial. At least 52,156 consecutive adult patients with nontraumatic acute chest discomfort and suspected MI presenting to the Emergency Department (ED) will be enrolled. Sites still using the ESC 0/3h-algorithm as standard-of-care will be randomized to implement the more rapid ESC 0/1h-algorithm at an early or late implementation step. During the validation phase, participating sites continue to use the ESC 0/3h-algorithm. The co-primary outcomes are a composite of type 1 MI or all-cause death at 30 days (safety), and the length of stay in the ED (efficacy). The trial is designed to show noninferiority for safety and superiority for efficacy, with a power of at least 90%.

Conclusions

PRESC1SE-MI is the largest international multicenter trial to date evaluating the safety and the efficacy of the implementation of the more rapid ESC 0/1h-algorithm at late adopting centers across multiple countries and healthcare systems. Its findings have the potential to improve patient care and reduce healthcare costs.
Trial registration: https://clinicaltrials.gov/study/NCT05649384.
背景:国际实践指南推荐更快速的欧洲心脏病学会(ESC) 0/1h算法作为疑似心肌梗死(MI)患者分诊的首选,并考虑ESC 0/3h算法作为替代方案。然而,由于不确定哪种方法最能平衡安全性和有效性,世界上许多中心尚未在临床实践中采用ESC 0/1h算法。方法:PRESC1SE-MI(欧洲心脏病学会0/1h算法对疑似心肌梗死患者分诊安全性和有效性的前瞻性评价)是一项国际研究人员发起的多中心、楔步式、聚类随机对照试验。至少52,156名连续到急诊科就诊的非创伤性急性胸部不适和疑似心肌梗死的成年患者将被纳入研究。仍然使用ESC 0/ h算法作为标准护理的站点将被随机分配,在早期或后期实施更快速的ESC 0/ h算法。在验证阶段,参与站点继续使用ESC 0/3h算法。共同主要结局是30天内1型心肌梗死或全因死亡(安全性)和在急诊科停留时间(有效性)的综合结果。该试验旨在显示安全性非劣效性和有效性优势,功效至少为90%。结论:PRESC1SE-MI是迄今为止最大的国际多中心试验,旨在评估在多个国家和医疗系统的后期采用中心实施更快速的ESC 0/1h算法的安全性和有效性。其研究结果有可能改善患者护理并降低医疗成本。
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引用次数: 0
A just-in-time adaptive mobile application intervention to reduce sodium intake and blood pressure in patients with hypertension: Rationale and design of the LowSalt4Life 2 trial 即时适应性移动应用干预降低高血压患者钠摄入量和血压:LowSalt4Life 2试验的基本原理和设计
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-27 DOI: 10.1016/j.ahj.2025.107294
Michael P. Dorsch PharmD, MS , Walter Dempsey PhD , Amy Krambrink MS , Sabah Ganai MPH , Kaitlyn M. Greer PhD , Mohamed S. Ali PharmD, SM , Chelsie Gesierich MPH , Margaret O’Neill BA , Brahmajee K. Nallamothu MD, MPH , Scott L. Hummel MD, MS

Background

Excess dietary sodium intake is a major contributor to hypertension (HTN) and cardiovascular disease in the U.S., yet most Americans exceed recommended sodium intake levels. Despite the established benefits of sodium reduction, behavioral adherence remains a challenge. Just-in-time adaptive interventions (JITAIs) provide a novel mobile health (mHealth) strategy to support low-sodium choices in real-time at restaurants and grocery stores.

Methods

LowSalt4Life 2 is a 6-month randomized controlled trial evaluating a mobile application-based sodium-focused JITAI among adults with HTN. In phase one, participants were randomized 1:1 to either the LowSalt4Life app with JITAI (App+JITAI) or the app alone. At 2 months, the App+JITAI group was re-randomized to either continue with the standard JITAI or receive a personalized JITAI (pJITAI) informed by reinforcement learning based on prior engagement. The primary outcome was change in systolic blood pressure (SBP) at 2 months. Secondary outcomes included changes in BP medication, dietary sodium intake, and engagement metrics.

Results

As of October 2025, 410 participants had been enrolled and completed follow-up. The trial's final results are anticipated in Spring 2025. Primary analysis focuses on the change in SBP between the App+JITAI and App-only groups, as well as the added value of personalization in the second study phase.

Conclusions

LowSalt4Life 2 tests a scalable, context-aware digital intervention designed to reduce dietary sodium and improve BP management. By personalizing engagement based on user behavior, this study seeks to advance mHealth strategies for HTN self-management and inform future interventions targeting dietary behaviors in real-world settings.
在美国,过量的膳食钠摄入是高血压(HTN)和心血管疾病的主要诱因,但大多数美国人的钠摄入量超过了推荐水平。尽管减少钠的益处已经确立,但行为上的坚持仍然是一个挑战。即时适应性干预(JITAIs)提供了一种新颖的移动健康(mHealth)策略,支持餐馆和杂货店实时选择低钠食品。方法:LowSalt4Life 2是一项为期6个月的随机对照试验,评估基于移动应用程序的成人HTN钠聚焦JITAI。在第一阶段,参与者以1:1的比例随机分配到带有JITAI (app +JITAI)的LowSalt4Life应用程序或单独使用该应用程序。在2个月时,App+JITAI组被重新随机分配,要么继续进行标准JITAI,要么接受基于先前参与的强化学习通知的个性化JITAI (pJITAI)。主要终点是2个月时收缩压(SBP)的变化。次要结局包括血压药物、饮食钠摄入量和参与指标的变化。结果:截至2025年10月,已有410名参与者入组并完成随访。该试验的最终结果预计将于2025年春季公布。初步分析App+JITAI组和App组的收缩压变化,以及第二阶段研究中个性化的附加价值。结论:LowSalt4Life 2测试了一种可扩展的、环境感知的数字干预措施,旨在减少饮食钠和改善血压管理。通过基于用户行为的个性化参与,本研究旨在推进HTN自我管理的移动健康策略,并为未来在现实环境中针对饮食行为的干预提供信息。
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引用次数: 0
Association of obesity subphenotypes with indices of cardiac remodeling in the Framingham heart study 弗雷明汉心脏研究中肥胖亚表型与心脏重塑指数的关联
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-19 DOI: 10.1016/j.ahj.2025.107292
William J. He MD MHS , Brenton R. Prescott MS , Vanessa Xanthakis PhD , Gary F. Mitchell MD , Susan Cheng MD , Ramachandran S. Vasan MD

Background

Previous studies have reported that obesity-related metabolic abnormalities (eg, diabetes and hypertension) lead to myocardial dysfunction and adverse cardiac remodeling. However, it is unclear whether such cardiac remodeling is from obesity or obesity-related metabolic abnormalities. We hypothesize that overweight and obesity are associated with adverse cardiac remodeling independent of associated metabolic abnormalities.

Methods

We evaluated 6,639 participants from the Framingham Heart Study who underwent echocardiography and had no prevalent cardiovascular disease. Individuals were classified into 6 obesity sub-phenotypes based on metabolic health (metabolically healthy or metabolically unhealthy) and body mass index (normal weight, overweight, or obese). Obesity subphenotypes were related to echocardiographic measures using multivariable regression analyses.

Results

Mean age was 49 years and 55% were women. Overweight and obesity were consistently associated with adverse cardiac remodeling in both metabolic healthy and unhealthy participants. Among metabolically healthy participants, compared to the normal weight group (referent), overweight and obesity were significantly associated with increased left ventricular mass (11.6 and 21.4 gm), left atrium end-systolic dimension (0.27 and 0.48 cm), global longitudinal strain (0.82 and 1.06%), and the ratio of early diastolic trans-mitral flow velocity to early diastolic mitral annulus velocity (0.35 and 0.87) (all P < .001). Additionally, obesity was significantly associated with mitral annular plane systolic excursion (0.08 cm, P < .001) and relative wall thickness (0.01, P = .001) compared to the normal weight referent group.

Conclusions

Increasing body weight was associated with adverse cardiac remodeling regardless of metabolic health status, which suggests that obesity may directly increase the risk of adverse cardiac remodeling.
背景:已有研究报道肥胖相关的代谢异常(如糖尿病和高血压)导致心肌功能障碍和不良的心脏重构。然而,目前尚不清楚这种心脏重塑是由肥胖还是肥胖相关的代谢异常引起的。我们假设超重和肥胖与不良的心脏重构相关,独立于相关的代谢异常。方法:我们评估了来自弗雷明汉心脏研究的6639名参与者,他们接受了超声心动图检查,没有流行的心血管疾病。根据代谢健康(代谢健康或代谢不健康)和体重指数(正常体重、超重或肥胖),将个体分为六种肥胖亚表型。使用多变量回归分析,肥胖亚表型与超声心动图测量结果相关。结果:平均年龄49岁,女性占55%。在代谢健康和不健康的参与者中,超重和肥胖始终与不良心脏重构相关。在代谢健康的参与者中,与正常体重组(参照)相比,超重和肥胖与左心室质量(11.6和21.4 gm)、左心房收缩末期尺寸(0.27和0.48 cm)、总纵向应变(0.82和1.06%)以及舒张早期二尖瓣血流速度与舒张早期二尖瓣环速度之比(0.35和0.87)显著相关(均p)。无论代谢健康状况如何,体重增加都与不良心脏重构相关,这表明肥胖可能直接增加不良心脏重构的风险。
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引用次数: 0
Distal versus conventional radial large-bore access for percutaneous coronary intervention of complex coronary lesions: Rationale and design of the DISCO COMPLEX randomized superiority trial 复杂冠状动脉病变经皮冠状动脉介入治疗的远端与传统桡骨大口径通道:DISCO complex随机优势试验的基本原理和设计。
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-18 DOI: 10.1016/j.ahj.2025.107291
Juan F. Iglesias MD , Gregor Leibundgut MD , Dik Heg PhD , Gabriele L. Gasparini MD , Grigorios Tsigkas MD, PhD , Claudiu Ungureanu MD , Giuseppe Colletti MD , Sophie Degrauwe MD , Panagiotis Xaplanteris MD, PhD , Karsten Schenke MD , Alexandru Achim MD , Maarten AH van Leeuwen MD, PhD , Maia Muresan MSc , Shigeru Saito MD , Gregory A. Sgueglia MD, PhD , Adel Aminian MD

Rationale

Distal radial access (DRA) has emerged as a promising alternative to conventional transradial access (TRA) for coronary angiography and percutaneous coronary intervention (PCI). However, existing randomized evidence on DRA primarily involves low-risk patients undergoing diagnostic angiography or noncomplex PCI using ≤6 French (Fr) introducer sheaths. The clinical benefits of DRA among patients undergoing PCI for complex coronary lesions using large-bore guide catheters remain therefore uncertain.

Design

DISCO COMPLEX is an investigator-initiated, prospective, multicenter, international, open-label, randomized, controlled trial with a blinded outcome assessment and superiority design. The trial will compare in a 1:1 ratio large-bore DRA versus conventional TRA using a 7-Fr introducer sheath in 708 patients undergoing PCI for complex coronary lesions (chronic total occlusions, left main disease, heavily calcified lesions, or complex bifurcations) with a 7-Fr guide catheter. The primary hypothesis is that large-bore DRA is superior to conventional TRA with respect to the incidence of forearm radial artery occlusion (RAO) assessed by Doppler ultrasound at hospital discharge. The prespecified DISCOPHILE COMPLEX hand function substudy is a noninferiority trial evaluating whether large-bore DRA is not inferior to conventional TRA with respect to change in full-Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire score from baseline to 12 months in participants of the DISCO COMPLEX trial.

Enrolment status

The trial aims to recruit a total of 708 patients from 10 to 15 participating centers across Europe. The first patient was enrolled on August 31, 2023. As of August 20, 2025, 385 patients have been included.

Conclusion

DISCO COMPLEX is the first randomized clinical trial designed to test the superiority of large-bore DRA over conventional TRA in reducing RAO rates among patients undergoing complex PCI with 7-Fr guide catheters.

Trial Registration

Clinicaltrials.gov: Identifier, NCT05490238.
理由:桡动脉远端通路(DRA)已成为传统经桡动脉通路(TRA)的替代方案,用于冠状动脉造影和经皮冠状动脉介入治疗(PCI)。然而,现有的DRA随机证据主要涉及使用≤6个French (Fr)导管套进行诊断性血管造影或非复杂PCI的低风险患者。因此,DRA在使用大口径导管接受复杂冠状动脉病变PCI治疗的患者中的临床益处仍不确定。设计:DISCO COMPLEX是一项研究者发起的、前瞻性、多中心、国际、开放标签、随机对照试验,采用盲法结局评估和优势设计。该试验将对708例因复杂冠状动脉病变(慢性全闭塞、左主干疾病、严重钙化病变或复杂分叉)使用7-Fr导管接受PCI的患者进行大口径DRA与使用7-Fr导管的传统TRA的1:1比例的比较。主要假设是大口径DRA在出院时通过多普勒超声评估前臂桡动脉闭塞(RAO)的发生率方面优于常规TRA。预先指定的DISCOPHILE COMPLEX手功能亚研究是一项非劣效性试验,评估大孔径DRA在DISCO COMPLEX试验参与者从基线到12个月的手臂、肩膀和手的全面残疾(DASH)问卷评分的变化方面是否不劣于常规TRA。入组状况:该试验旨在从欧洲10至15个参与中心招募总共708名患者。第一位患者于2023年8月31日入组。截至2025年8月20日,共纳入385例患者。结论:DISCO COMPLEX是首个随机临床试验,旨在测试大口径DRA在降低采用7-Fr导管的复杂PCI患者的RAO率方面优于传统TRA。
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引用次数: 0
Worsening heart failure events in adults with mild-to-moderate chronic kidney disease 成人轻中度慢性肾病患者心衰事件加重
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-17 DOI: 10.1016/j.ahj.2025.107290
Linda Ye MD , Michael P. Girouard MD, MBA , Alan S. Go MD , Jane Y. Liu MPH , Rishi V. Parikh MPH , Thida C. Tan MPH , Emily S. Lee MD , Grace Sun BA , Rami Halaseh MD , Ankeet S. Bhatt MD, MBA, ScM , Leonid Pravoverov MD , Sijie Zheng MD , Jana Svetlichnaya MD , Jesse K. Fitzpatrick MD , Harshith R. Avula MD, MPH , Keane K. Lee MD, MS , Sirtaz Adatya MD , David Ouyang MD , Parag Goyal MD, MSc , Alexander T. Sandhu MD, MS , Andrew P. Ambrosy MD, MPH

Background

Chronic kidney disease (CKD) is a major risk factor for heart failure (HF). However, the burden of worsening HF (WHF) events among adults with mild-to-moderate CKD has not been well described.

Objectives

This study assessed the burden of WHF in a contemporary cohort of adults with mild-to-moderate CKD.

Methods

We identified adults with mild-to-moderate CKD (eGFR 30-59 mL/min/1.73m² or eGFR ≥60 mL/min/1.73m² with albuminuria) within a large, integrated healthcare delivery system from 2012 to 2021. Outcomes included hospitalizations, emergency department visits, and outpatient encounters for WHF, stratified by HF status and level of CKD.

Results

Among 375,495 adults with mild-to-moderate CKD, mean age was 64 ± 16 years, 54% were women, mean eGFR was 76 ± 26 mL/min/1.73m², and 6.5% had prior known HF. CKD stages G1A2 (31.6%), G2A2 (24.9%), and G3aA1 (25.1%) were most prevalent. Rates (95% CI) per 100 person-years for WHF events were 1.85 (1.83-1.87) for hospitalizations, 0.85 (0.84-0.86) for emergency department visits, and 0.83 (0.81-0.84) for outpatient encounters, resulting in a cumulative rate of 2.42 (2.40-2.44). Event rates were higher at lower eGFR and higher albuminuria levels.

Conclusions

WHF is a common source of morbidity in adults with earlier stage CKD, and particularly high in those with lower eGFR and greater albuminuria. These findings underscore the importance of implementing available and emerging cardioprotective and renoprotective therapies in this high-risk population.
背景:慢性肾脏疾病(CKD)是心力衰竭(HF)的主要危险因素。然而,在患有轻中度CKD的成人中,HF (WHF)事件恶化的负担尚未得到很好的描述。目的:本研究评估了当代轻至中度CKD成人队列中WHF的负担。方法:我们在2012-2021年的大型综合医疗保健服务系统中确定了轻度至中度CKD (eGFR 30-59 ml/min/1.73m²或eGFR≥60 ml/min/1.73m²伴有蛋白尿)的成人。结果包括住院、急诊科就诊和WHF门诊就诊,按HF状态和CKD水平分层。结果:在375,495名轻中度CKD成人患者中,平均年龄为64±16岁,54%为女性,平均eGFR为76±26 ml/min/1.73m²,6.5%既往已知HF。CKD分期G1A2(31.6%)、G2A2(24.9%)和G3aA1(25.1%)最为常见。住院患者每100人年WHF事件发生率(95% CI)为1.85(1.83-1.87),急诊患者为0.85(0.84-0.86),门诊患者为0.83(0.81-0.84),累计发生率为2.42(2.40-2.44)。eGFR越低,蛋白尿越高,事件发生率越高。结论:WHF是早期CKD成人发病的常见原因,在eGFR较低和蛋白尿较多的患者中发病率尤其高。这些发现强调了在这一高危人群中实施现有的和新兴的心脏保护和肾保护疗法的重要性。
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引用次数: 0
Functional coronary angiogram findings in angina with non-obstructive coronary arteries patients with coronary slow flow ANOCA患者冠状动脉慢血流的功能性冠状动脉造影表现。
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-09 DOI: 10.1016/j.ahj.2025.107287
Olivia Girolamo BMedSc , Muhammad Dzafir Ismail MBBS, MMed , Rosanna Tavella BSc, PhD , Eng Lee Ooi MBBS, PhD , Sivabaskari Pasupathy BSc, PhD , Sarena La BMedSc , Abdul Sheikh MBBS, MD , Christopher Zeitz MBBS, PhD , John Beltrame BSc, BMBS, PhD

Background

The Coronary Slow Flow Phenomenon (CSFP) is considered a coronary microvascular disorder and has been defined as a corrected thrombolysis in myocardial infarction frame count (cTFC) ≥25 frames. Recent invasive physiology studies have reported that cTFC is not a surrogate marker for coronary microvascular dysfunction (CMD), defined by an abnormal Coronary Flow Reserve (CFR), questioning the integrity of CSFP. This study evaluates the Functional Coronary Angiography (FCA) findings of patients with and without CSFP, as well as the relationship between cTFC and invasive coronary functional measures.

Methods

FCA utilizing a pressure-Doppler flow wire during adenosine infusion, and acetylcholine provocation, was undertaken in 103 patients with angina and non-obstructive coronary artery disease (<50% stenosis; ANOCA).

Results

The FCA findings revealed CMD (i.e. CFR<2) in 43%, inducible coronary artery spasm (58%) and microvascular spasm (13%) in patients with the CSFP (n = 69), which was similar to those without CSFP (n = 34). However, the CSFP patients had a lower resting coronary blood flow velocity (19 ± 7 vs 23 ± 7cm/s, P = .009) with higher resting microvascular resistance (5.8 ± 1.9 vs 4.4 ± 1.7mmHg/cm/s, P = .006) and higher hyperemic microvascular resistance (2.35 ± 1.09 vs 1.94 ± 0.93, P = .049), despite a similar hyperemic CFR (2.25 ± 0.84 vs 2.26 ± 0.58, P = .971) compared to those without CSFP. Furthermore, the cTFC as a continuous measure, correlated with resting coronary blood flow, resting/hyperemic resistance but not CFR.

Conclusion

The conventional marker of CMD (i.e. CFR <2) was similar in patients with/without the CSFP. However alternative hemodynamic markers of impaired coronary microvascular function were abnormal in patients with the CSFP, including resting/hyperemic coronary microvascular resistance. Moreover, cTFC is a simple semi-quantitative marker correlated with coronary microvascular resistance and thus has clinical utility in the diagnosis of the CSFP.
背景:冠状动脉慢血流现象(CSFP)被认为是冠状动脉微血管疾病,并被定义为心肌梗死帧数(cTFC)≥25帧时的纠正溶栓。最近的侵入性生理学研究报道,cTFC不是冠状动脉微血管功能障碍(CMD)的替代标志物,CMD是由冠状动脉血流储备异常(CFR)定义的,这对ccsf的完整性提出了质疑。本研究评估有和无ccsf患者的功能性冠状动脉造影(FCA)结果,以及cTFC与有创冠状动脉功能测量的关系。方法:对103例心绞痛合并非阻塞性冠状动脉疾病患者,在腺苷输注和乙酰胆碱激发下,采用压力多普勒血流线进行FCA检查(结果:FCA检查显示CMD(即CFR))
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引用次数: 0
Information for Readers 读者资讯
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-07 DOI: 10.1016/S0002-8703(25)00343-6
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引用次数: 0
Statistical methodological limitations and improvement suggestions in the study of vitamin D deficiency and cardiovascular mortality after heart transplantation 维生素D缺乏与心脏移植后心血管死亡率研究的统计方法局限性及改进建议。
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-07 DOI: 10.1016/j.ahj.2025.08.015
Haiying Hu BSc, Linjun Wang BSc
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引用次数: 0
Bioimpedance phase angle is associated with increased heart failure hospitalization risk 生物阻抗相位角与心力衰竭住院风险增加有关。
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-07 DOI: 10.1016/j.ahj.2025.107288
Kivanc Ozonat PhD , Corey Centen B.Eng , Sarah Smith B.Eng , V. Burak Aydemir PhD , Marat Fudim MD, MHS , Adam D. DeVore MD, MHS

Background

Outcomes for patients living with heart failure (HF) remain poor with high rates of death and hospitalization due to worsening HF. Noninvasive tools may be useful to identify patients at risk for disease progression before these outcomes occur. For example, loss of cell mass and compromised cell membrane integrity throughout the body are associated with chronic disease, mortality, frailty, and malnutrition. As the cell membrane loses its integrity, its electrical capacitance decreases, lowering bioelectrical phase angle. Data collected during the SCALE-HF 1 study (NCT04882449) was used to evaluate bioelectrical phase angle as a marker for heart failure (HF) hospitalization risk. Phase angle was measured by the FDA-cleared Bodyport Cardiac Scale.

Methods

SCALE-HF 1 was a multicenter, prospective, observational study, investigating HF event prediction. Baseline phase angle was measured during the first week in the study with the patient standing barefoot on the Cardiac Scale at home for approximately 20 seconds. HF hospitalizations were independently adjudicated. The analysis was based on univariable and multivariable Cox regression models adjusted for age, sex, race, body mass index (BMI), left ventricular ejection fraction (LVEF), inpatient status at enrollment, and selected comorbidities and laboratory tests.

Results

329 participants with HF were enrolled across 8 US sites with 238 patient-years of follow-up. 312 (95%) of the participants had a baseline phase angle, and 57 (18%) of those had a HF hospitalization during the follow-up period. Participants with baseline phase angle in the lowest quartile (suggesting worse cell membrane integrity) were at increased risk for HF hospitalization compared to participants with baseline phase angle in the highest quartile (Hazard ratio: 3.44, 95% CI: 1.55 to 7.63, P = .002). When adjusted for risk factors selected from age, sex, race, BMI, LVEF, laboratory tests and comorbidities in the multivariable model, participants with baseline phase angle in the lowest quartile continued to be at increased risk for HF hospitalization compared to participants with baseline phase angle in the highest quartile (Hazard ratio: 3.51, 95% CI: 1.73 to 7.12, P < .001).

Conclusions

Phase angle was found to be independently associated with HF hospitalization risk. The noninvasive measurement, acquired with a familiar scale form factor, may help guide remote care and triage.

Trial Registration

ClinicalTrials.gov NCT04882449. https://clinicaltrials.gov/study/NCT04882449.
背景:心力衰竭(HF)患者的预后仍然很差,由于心衰恶化导致的死亡率和住院率很高。非侵入性工具可能有助于在这些结果发生之前识别有疾病进展风险的患者。例如,全身细胞质量损失和细胞膜完整性受损与慢性疾病、死亡率、虚弱和营养不良有关。当细胞膜失去完整性时,其电容量减小,生物电相角降低。SCALE-HF 1研究(NCT04882449)收集的数据用于评估生物电相角作为心力衰竭住院风险的标志。相位角由fda批准的Bodyport心脏秤测量。方法:SCALE-HF 1是一项多中心、前瞻性、观察性研究,旨在探讨心衰事件的预测。基线相位角在研究的第一周测量,患者赤脚站在家里的心脏秤上大约20秒。心衰住院是独立裁决的。分析基于单变量和多变量Cox回归模型,校正了年龄、性别、种族、体重指数(BMI)、左室射血分数(LVEF)、入组时的住院情况、选定的合并症和实验室检查。结果:329名HF患者在美国8个研究中心接受了238例患者年的随访。312名(95%)参与者有基线相位角,57名(18%)参与者在随访期间有心衰住院。基线相位角在最低四分位数的参与者(表明细胞膜完整性较差)与基线相位角在最高四分位数的参与者相比,HF住院的风险增加(风险比:3.44,95%可信区间:1.55至7.63,p=0.002)。在多变量模型中,对年龄、性别、种族、BMI、LVEF、实验室检查和合并症等危险因素进行调整后,基线相位角处于最低四分位数的参与者与基线相位角处于最高四分位数的参与者相比,HF住院的风险继续增加(风险比:3.51,95%置信区间:1.73至7.12)。无创测量,以熟悉的规模形式因素获得,可能有助于指导远程护理和分诊。试验注册:ClinicalTrials.gov NCT04882449。https://clinicaltrials.gov/study/NCT04882449。
{"title":"Bioimpedance phase angle is associated with increased heart failure hospitalization risk","authors":"Kivanc Ozonat PhD ,&nbsp;Corey Centen B.Eng ,&nbsp;Sarah Smith B.Eng ,&nbsp;V. Burak Aydemir PhD ,&nbsp;Marat Fudim MD, MHS ,&nbsp;Adam D. DeVore MD, MHS","doi":"10.1016/j.ahj.2025.107288","DOIUrl":"10.1016/j.ahj.2025.107288","url":null,"abstract":"<div><h3>Background</h3><div>Outcomes for patients living with heart failure (HF) remain poor with high rates of death and hospitalization due to worsening HF. Noninvasive tools may be useful to identify patients at risk for disease progression before these outcomes occur. For example, loss of cell mass and compromised cell membrane integrity throughout the body are associated with chronic disease, mortality, frailty, and malnutrition. As the cell membrane loses its integrity, its electrical capacitance decreases, lowering bioelectrical phase angle. Data collected during the SCALE-HF 1 study (NCT04882449) was used to evaluate bioelectrical phase angle as a marker for heart failure (HF) hospitalization risk. Phase angle was measured by the FDA-cleared Bodyport Cardiac Scale.</div></div><div><h3>Methods</h3><div>SCALE-HF 1 was a multicenter, prospective, observational study, investigating HF event prediction. Baseline phase angle was measured during the first week in the study with the patient standing barefoot on the Cardiac Scale at home for approximately 20 seconds. HF hospitalizations were independently adjudicated. The analysis was based on univariable and multivariable Cox regression models adjusted for age, sex, race, body mass index (BMI), left ventricular ejection fraction (LVEF), inpatient status at enrollment, and selected comorbidities and laboratory tests.</div></div><div><h3>Results</h3><div>329 participants with HF were enrolled across 8 US sites with 238 patient-years of follow-up. 312 (95%) of the participants had a baseline phase angle, and 57 (18%) of those had a HF hospitalization during the follow-up period. Participants with baseline phase angle in the lowest quartile (suggesting worse cell membrane integrity) were at increased risk for HF hospitalization compared to participants with baseline phase angle in the highest quartile (Hazard ratio: 3.44, 95% CI: 1.55 to 7.63, <em>P</em> = .002). When adjusted for risk factors selected from age, sex, race, BMI, LVEF, laboratory tests and comorbidities in the multivariable model, participants with baseline phase angle in the lowest quartile continued to be at increased risk for HF hospitalization compared to participants with baseline phase angle in the highest quartile (Hazard ratio: 3.51, 95% CI: 1.73 to 7.12, <em>P</em> &lt; .001).</div></div><div><h3>Conclusions</h3><div>Phase angle was found to be independently associated with HF hospitalization risk. The noninvasive measurement, acquired with a familiar scale form factor, may help guide remote care and triage.</div></div><div><h3>Trial Registration</h3><div>ClinicalTrials.gov NCT04882449. <span><span>https://clinicaltrials.gov/study/NCT04882449</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107288"},"PeriodicalIF":3.5,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145249401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Response to letter by Hu regarding article, “Statistical Methodological Limitations and Improvement Suggestions in the Study of Vitamin D Deficiency and Cardiovascular Mortality After Heart Transplantation.” 回复胡先生关于“心脏移植后维生素D缺乏与心血管疾病死亡率研究的统计方法局限性和改进建议”一文的来信。
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-10-07 DOI: 10.1016/j.ahj.2025.08.016
Matthew Gold MD , Sarah Kulkarni MSPH , Arshed Quyyumi MD
{"title":"Response to letter by Hu regarding article, “Statistical Methodological Limitations and Improvement Suggestions in the Study of Vitamin D Deficiency and Cardiovascular Mortality After Heart Transplantation.”","authors":"Matthew Gold MD ,&nbsp;Sarah Kulkarni MSPH ,&nbsp;Arshed Quyyumi MD","doi":"10.1016/j.ahj.2025.08.016","DOIUrl":"10.1016/j.ahj.2025.08.016","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 218-219"},"PeriodicalIF":3.5,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145257101","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
American heart journal
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