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Remote Follow-up in a Heart Failure Pragmatic Trial: Insights From the CONNECT-HF 心力衰竭实用性试验中的远程随访:来自 CONNECT-HF 的启示。
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-01 DOI: 10.1016/j.cardfail.2024.03.006
SATOSHI SHOJI MD, PhD , LISA A. KALTENBACH MS , BRADI B. GRANGER PhD, RN , GREGG C. FONAROW MD , HUSSEIN R. AL-KHALIDI PhD , NANCY M. ALBERT PhD, RN , JAVED BUTLER MD, MPH, MBA , LARRY A. ALLEN MD, MHS , G. MICHAEL FELKER MD, MHS , ROBERT W. HARRISON MD , MARAT FUDIM MD, MHS , ADAM J. NELSON MBBS, PhD , CHRISTOPHER B. GRANGER MD , ADRIAN F. HERNANDEZ MD, MHS , ADAM D. DEVORE MD, MHS

Background

Randomized controlled trials typically require study-specific visits, which can burden participants and sites. Remote follow-up, such as centralized call centers for participant-reported or site-reported, holds promise for reducing costs and enhancing the pragmatism of trials. In this secondary analysis of the CONNECT-HF (Care Optimization Through Patient and Hospital Engagement For HF) trial, we aimed to evaluate the completeness and validity of the remote follow-up process.

Methods and Results

The CONNECT-HF trial evaluated the effect of a post-discharge quality-improvement intervention for heart failure compared to usual care for up to 1 year. Suspected events were reported either by participants or by health care proxies through a centralized call center or by sites through medical-record queries. When potential hospitalization events were suspected, additional medical records were collected and adjudicated. Among 5942 potential hospitalizations, 18% were only participant-reported, 28% were reported by both participants and sites, and 50% were only site-reported. Concordance rates between the participant/site reports and adjudication for hospitalization were high: 87% participant-reported, 86% both, and 86% site-reported. Rates of adjudicated heart failure hospitalization events among adjudicated all-cause hospitalization were lower but also consistent: 45% participant-reported, 50% both, and 50% site-reported.

Conclusions

Participant-only and site-only reports missed a substantial number of hospitalization events. We observed similar concordance between participant/site reports and adjudication for hospitalizations. Combining participant-reported and site-reported outcomes data is important to capture and validate hospitalizations effectively in pragmatic heart failure trials.
背景随机对照试验通常需要对特定研究进行访问,这会给参与者和研究机构造成负担。远程随访,如通过集中呼叫中心进行参与者报告或研究机构报告,有望降低成本并提高试验的实用性。在这项 CONNECT-HF(通过患者和医院参与优化心力衰竭护理)试验的二次分析中,我们旨在评估远程随访过程的完整性和有效性。方法和结果CONNECT-HF 试验评估了出院后心力衰竭质量改善干预与常规护理相比长达 1 年的效果。疑似事件由参与者或医疗代理通过中央呼叫中心报告,或由医疗机构通过医疗记录查询报告。当怀疑可能发生住院事件时,会收集更多的医疗记录并进行判定。在 5942 例潜在住院事件中,18% 仅由参与者报告,28% 由参与者和医疗点共同报告,50% 仅由医疗点报告。参与者/医疗点报告与住院裁定之间的一致率很高:参与者报告占 87%,参与者和医疗点报告均占 86%,医疗点报告占 86%。在裁定的全因住院事件中,裁定的心衰住院事件比率较低,但也是一致的:结论仅参与者报告和仅现场报告遗漏了大量住院事件。我们观察到参与者/现场报告与住院裁定之间具有相似的一致性。结合参与者报告和研究机构报告的结果数据对于在实用性心衰试验中有效捕捉和验证住院事件非常重要。
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引用次数: 0
Unmasking HFpEF With Artificial Intelligence: A Disruptive Opportunity for Disease Detection 用人工智能揭开高频低氧血症的神秘面纱:疾病检测的颠覆性机遇。
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-01 DOI: 10.1016/j.cardfail.2024.02.010
AMOGH KARNIK MD, MSc, MADELINE JANKOWSKI RDCS, AKHIL NARANG MD
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引用次数: 0
Direct Oral Anticoagulant Therapy With A Fully Magnetically Levitated LVAD and Bridging to Heart Transplantation: A DOT-HM3 Study Analysis 使用全磁悬浮 LVAD 的直接口服抗凝疗法与心脏移植的衔接:DOT-HM3 研究分析。
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-01 DOI: 10.1016/j.cardfail.2024.05.005
IVAN NETUKA MD, PhD , ZUZANA TUCANOVA MD , MANDEEP R. MEHRA MD, MSc
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引用次数: 0
Ventricular Assist Devices During an Economical Collapse: Challenges and Outcomes 经济崩溃时期的心室辅助设备:挑战与成果。
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-01 DOI: 10.1016/j.cardfail.2024.04.028
Angela Massouh PhD, FESC, FHFA , Hadi Skouri MD, FESC, FACC, FHFA, FHFSA
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引用次数: 0
Going With the Flow: Device Therapy for Heart Failure Complicated by Cardiorenal Syndrome 随波逐流:心力衰竭并发心肾综合征的设备治疗。
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-01 DOI: 10.1016/j.cardfail.2024.02.006
LINDSEY AURORA MD, GILLIAN GRAFTON DO, JENNIFER COWGER MD, MS
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引用次数: 0
Left Ventricular Assist Devices in Latin America: Current Landscape and Future Directions 拉丁美洲的左心室辅助设备:当前形势与未来方向》。
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-01 DOI: 10.1016/j.cardfail.2024.08.041
PAOLA MOREJÓN BARRAGÁN MD , CHRISTIAN GUILLIOD MD , LUCRECIA M. BURGOS MD , VANESSA BLUMER MD
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引用次数: 0
Real-world walking behaviors are associated with early-stage heart failure: a Project Baseline Health Study 现实世界中的步行行为与早期心力衰竭有关:健康基线项目研究
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-01 DOI: 10.1016/j.cardfail.2024.02.028
Sooyoon Shin PhD , Nathan Kowahl MS , Taylor Hansen PhD , Albee Y. Ling PhD , Poulami Barman MS , Nicholas Cauwenberghs PhD , Erin Rainaldi MS , Sarah Short MPH , Jessilyn Dunn PhD , Md Mobashir Hasan Shandhi PhD , Svati H. Shah MD, MHS , Kenneth W. Mahaffey MD , Tatiana Kuznetsova MD, PhD , Melissa A. Daubert MD , Pamela S. Douglas MD , Francois Haddad MD , Ritu Kapur PhD

Background

Data collected via wearables may complement in-clinic assessments to monitor subclinical heart failure (HF).

Objectives

Evaluate the association of sensor-based digital walking measures with HF stage and characterize their correlation with in-clinic measures of physical performance, cardiac function and participant reported outcomes (PROs) in individuals with early HF.

Methods

The analyzable cohort included participants from the Project Baseline Health Study (PBHS) with HF stage 0, A, or B, or adaptive remodeling phenotype (without risk factors but with mild echocardiographic change, termed RF-/ECHO+) (based on available first-visit in-clinic test and echocardiogram results) and with sufficient sensor data. We computed daily values per participant for 18 digital walking measures, comparing HF subgroups vs stage 0 using multinomial logistic regression and characterizing associations with in-clinic measures and PROs with Spearman's correlation coefficients, adjusting all analyses for confounders.

Results

In the analyzable cohort (N=1265; 50.6% of the PBHS cohort), one standard deviation decreases in 17/18 walking measures were associated with greater likelihood for stage-B HF (multivariable-adjusted odds ratios [ORs] vs stage 0 ranging from 1.18-2.10), or A (ORs vs stage 0, 1.07-1.45), and lower likelihood for RF-/ECHO+ (ORs vs stage 0, 0.80-0.93). Peak 30-minute pace demonstrated the strongest associations with stage B (OR vs stage 0=2.10; 95% CI:1.74-2.53) and A (OR vs stage 0=1.43; 95% CI:1.23-1.66). Decreases in 13/18 measures were associated with greater likelihood for stage-B HF vs stage A. Strength of correlation with physical performance tests, echocardiographic cardiac-remodeling and dysfunction indices and PROs was greatest in stage B, then A, and lowest for 0.

Conclusions

Digital measures of walking captured by wearable sensors could complement clinic-based testing to identify and monitor pre-symptomatic HF.
通过可穿戴设备收集的数据可以补充临床评估,监测亚临床心力衰竭(HF)。评估基于传感器的数字步行测量与心力衰竭分期的相关性,并描述其与早期心力衰竭患者的临床体能、心脏功能和参与者报告结果(PROs)的相关性。可分析的队列包括 "基线健康研究项目"(PBHS)的参与者,他们均为高血压 0、A 或 B 期或适应性重塑表型(无风险因素但有轻微超声心动图改变,称为 RF-/ECHO+)(基于可用的首次门诊测试和超声心动图结果),并有足够的传感器数据。我们计算了每位参与者每天的 18 项数字行走测量值,使用多叉逻辑回归法比较了高血压亚组与 0 期,并使用斯皮尔曼相关系数分析了与门诊测量值和 PROs 之间的关系,同时对所有分析进行了混杂因素调整。在可分析队列(N=1265;占 PBHS 队列的 50.6%)中,17/18 项步行指标每降低一个标准差,B 期或 A 期(多变量调整后的比值比 [ORs] vs 0 期,范围为 1.18-2.10)或 A 期(比值比 vs 0 期,1.07-1.45)的可能性就会增加,而 RF-/ECHO+ 的可能性则会降低(比值比 vs 0 期,0.80-0.93)。30 分钟峰值速度与 B 阶段(OR vs 阶段 0=2.10;95% CI:1.74-2.53)和 A 阶段(OR vs 阶段 0=1.43;95% CI:1.23-1.66)的关联性最强。与体能测试、超声心动图心脏重塑和功能障碍指数以及PROs相关性最强的是B期,其次是A期,最低的是0期。可穿戴传感器捕获的步行数字测量值可补充临床测试,以识别和监测症状前HF。
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引用次数: 0
Prognostic Implications of Quantifying Vasoactive Medications in Cardiogenic Shock 量化心源性休克血管活性药物的预后意义
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-01 DOI: 10.1016/j.cardfail.2024.06.010
SARASCHANDRA VALLABHAJOSYULA MD, MSC , ANTHONY J. FAUGNO MD , BORUI LI MA , KEVIN JOHN MD , QIUYUE KONG MA , SHASHANK S. SINHA MD, MSC , JAIME HERNANDEZ-MONTFORT MD , MANREET K. KANWAR MD , JACOB ABRAHAM MD , VANESSA BLUMER MD , MARYJANE FARR MD, MSC , JUSTIN FRIED MD , ARTHUR R. GARAN MD , SHELLEY HALL MD , GAVIN W. HICKEY MD , RACHNA KATARIA MD , JU KIM MD , SONG LI MD , CLAUDIUS MAHR MD , SANDEEP NATHAN MD, MSC , NAVIN K. KAPUR MD
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引用次数: 0
When Medical Necessity Isn't Persuasive Enough: Utilizing Patient Social Media Support Communities To Induce Acceptance Of Cardiac ProceduresA Study In Social Media's Role in Implanted Cardiac Device Acceptance 当医疗必要性不足以说服人时:利用患者社交媒体支持社区诱导接受心脏手术社交媒体在植入式心脏设备接受度中的作用研究
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-01 DOI: 10.1016/j.cardfail.2024.10.433
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引用次数: 0
Efficacy and Safety of Aficamten in Symptomatic Nonobstructive Hypertrophic Cardiomyopathy: Results From the REDWOOD-HCM Trial, Cohort 4 阿非坎顿治疗症状性非梗阻性肥厚型心肌病的有效性和安全性:REDWOOD-HCM试验第4队列的结果。
IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-01 DOI: 10.1016/j.cardfail.2024.02.020
AHMAD MASRI MD, MS , MARK V. SHERRID MD , THEODORE P. ABRAHAM MD , LUBNA CHOUDHURY MD, MRCPI , PABLO GARCIA-PAVIA MD, PhD , CHRISTOPHER M. KRAMER MRCPI , ROBERTO BARRIALES-VILLA MD, PhD , ANJALI T. OWENS MD , FLORIAN RADER MD , SHERIF F. NAGUEH MD , IACOPO OLIVOTTO MD , SARA SABERI MD , ALBREE TOWER-RADER MD , TIMOTHY C. WONG MD , CAROLINE J. COATS MD, PhD , HUGH WATKINS MD, PhD , MICHAEL A. FIFER MD , SCOTT D. SOLOMON MD , STEPHEN B. HEITNER MD , DANIEL L. JACOBY MD , MARTIN S. MARON MD

Background

This open-label phase 2 trial evaluated the safety and efficacy of aficamten in patients with nonobstructive hypertrophic cardiomyopathy (nHCM).

Methods

Patients with symptomatic nHCM (left ventricular outflow tract obstruction gradient ≤ 30 mmHg, left ventricular ejection fraction [LVEF] ≥ 60%, N-terminal pro-B-type natriuretic peptide [NT-proBNP] > 300 pg/mL) received aficamten 5–15 mg once daily (doses adjusted according to echocardiographic LVEF) for 10 weeks.

Results

We enrolled 41 patients (mean ± SD age 56 ± 16 years; 59% female). At Week 10, 22 (55%) patients experienced an improvement of ≥ 1 New York Heart Association class; 11 (29%) became asymptomatic. Clinically relevant improvements in Kansas City Cardiomyopathy Questionnaire Clinical Summary Scores occurred in 22 (55%) patients. Symptom relief was paralleled by reductions in NT-proBNP levels (56%; P < 0.001) and high-sensitivity cardiac troponin I (22%; P < 0.005). Modest reductions in LVEF (mean ± SD) of −5.4% ± 10 to 64.6% ± 9.1 were observed. Three (8%) patients had asymptomatic reduction in LVEF < 50% (range: 41%–48%), all returning to normal after 2 weeks of washout. One patient with prior history of aborted sudden cardiac death experienced a fatal arrhythmia during the study.

Conclusions

Aficamten administration for symptomatic nHCM was generally safe and was associated with improvements in heart failure symptoms and cardiac biomarkers.

Trial registration

ClinicalTrials.gov Identifier: NCT04219826
背景这项开放标签的2期试验评估了非卡坦治疗非梗阻性肥厚型心肌病(nHCM)患者的安全性和有效性:有症状的nHCM患者(左心室流出道阻塞梯度≤30 mmHg、左心室射血分数[LVEF]≥60%、N末端前B型钠尿肽[NT-proBNP]>300 pg/mL)接受阿菲康坦治疗,每日一次,每次5-20 mg(根据超声心动图LVEF调整剂量),为期10周:41名患者(平均± SD年龄为56±16岁;59%为女性)入组。第 10 周时,22 名患者(55%)的纽约心脏协会分级≥1 级;11 名患者(29%)无症状。22名(55%)患者的堪萨斯城心肌病问卷临床总分有了临床意义上的改善。症状缓解的同时,NT-proBNP(56%;P < 0.001)和高敏心肌肌钙蛋白 I(22%;P < 0.005)也有所下降。观察到 LVEF 略有降低(平均值 ± SD),从 -5.4% ± 10 降至 64.6% ± 9.1。结论:对有症状的 nHCM 患者使用阿菲康坦总体上是安全的,并能改善心衰症状和心脏生物标志物:试验注册:ClinicalTrials.gov Identifier:NCT04219826 摘要:非阻塞性肥厚型心肌病(nHCM)是一种心肌异常增厚的疾病。目前尚无成熟的药物疗法。Aficamten 是一种新型心肌肌球蛋白抑制剂,旨在针对肥厚性心肌病的根本原因进行治疗。REDWOOD-HCM Cohort 4 是探索阿菲康坦对有 nHCM 症状的患者的疗效和安全性的第一项研究。大多数患者的健康状况和功能状态都有所改善。血液中表明心脏压力过大和心肌细胞受损的生物标志物水平也明显下降。这些结果支持对 nHCM 患者进行更大规模的安慰剂对照研究(ACACIA-HCM)。
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引用次数: 0
期刊
Journal of Cardiac Failure
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