European Journal of Heart Failure最新文献

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MAGGIC and PREDICT-HF Models in the VICTOR Trial: Do Traditional Risk Scores Still Work in Well-Treated Ambulatory Patients with HFrEF? VICTOR试验中的magic和PREDICT-HF模型:传统的风险评分对治疗良好的HFrEF门诊患者仍然有效吗?
IF 10.3 1区 医学
European Journal of Heart Failure Pub Date : 2026-09-21 DOI: 10.1093/ejhf/xuag297
Michele Senni, Javed Butler, Derek Cyr, Kevin J Anstrom, Irina Barash, Marc P Bonaca, Matthew Budoff, Myeong-Chan Cho, Maria Generosa Crespo-Leiro, Stefano Corda, Justin Ezekowitz, Carolyn S P Lam, Eldrin F Lewis, JoAnn Lindenfeld, Ciaran J McMullan, Robert J Mentz, Christopher M O'Connor, Piotr Ponikowski, Yogesh N V Reddy, Giuseppe Rosano, Clara Saldarriaga, James Udelson, Jose Vazquez-Tanus, Adriaan A Voors, Faiez Zannad
{"title":"MAGGIC and PREDICT-HF Models in the VICTOR Trial: Do Traditional Risk Scores Still Work in Well-Treated Ambulatory Patients with HFrEF?","authors":"Michele Senni, Javed Butler, Derek Cyr, Kevin J Anstrom, Irina Barash, Marc P Bonaca, Matthew Budoff, Myeong-Chan Cho, Maria Generosa Crespo-Leiro, Stefano Corda, Justin Ezekowitz, Carolyn S P Lam, Eldrin F Lewis, JoAnn Lindenfeld, Ciaran J McMullan, Robert J Mentz, Christopher M O'Connor, Piotr Ponikowski, Yogesh N V Reddy, Giuseppe Rosano, Clara Saldarriaga, James Udelson, Jose Vazquez-Tanus, Adriaan A Voors, Faiez Zannad","doi":"10.1093/ejhf/xuag297","DOIUrl":"https://doi.org/10.1093/ejhf/xuag297","url":null,"abstract":"","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":" ","pages":""},"PeriodicalIF":10.3,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149014845","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Fragility metrics are the wrong tool for finerenone's cardiovascular evidence. 脆弱性指标是一个错误的工具,不能用来证明芬芬酮的心血管疾病。
IF 10.3 1区 医学
European Journal of Heart Failure Pub Date : 2026-09-16 DOI: 10.1093/ejhf/xuag228
Shankar Biswas, Yashasvi Srivastava, Susruth Kumar Bandaru
{"title":"Fragility metrics are the wrong tool for finerenone's cardiovascular evidence.","authors":"Shankar Biswas, Yashasvi Srivastava, Susruth Kumar Bandaru","doi":"10.1093/ejhf/xuag228","DOIUrl":"https://doi.org/10.1093/ejhf/xuag228","url":null,"abstract":"","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":" ","pages":""},"PeriodicalIF":10.3,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148975223","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Interpreting fragility indices in finerenone trials: complementary insights into statistical stability. 解读芬烯酮试验中的脆弱性指数:对统计稳定性的补充见解。
IF 10.3 1区 医学
European Journal of Heart Failure Pub Date : 2026-09-16 DOI: 10.1093/ejhf/xuag198
Marco Zuin, Gregory Piazza
{"title":"Interpreting fragility indices in finerenone trials: complementary insights into statistical stability.","authors":"Marco Zuin, Gregory Piazza","doi":"10.1093/ejhf/xuag198","DOIUrl":"https://doi.org/10.1093/ejhf/xuag198","url":null,"abstract":"","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":" ","pages":""},"PeriodicalIF":10.3,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148975193","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Mortality benefit and lifetime survival gains with vericiguat in HFrEF: Bayesian and actuarial analyses of the VICTOR trial. 在HFrEF中,死亡率获益和终生生存获益:VICTOR试验的贝叶斯和精算分析。
IF 10.3 1区 医学
European Journal of Heart Failure Pub Date : 2026-09-16 DOI: 10.1093/ejhf/xuag267
Francesco Fioretti, Faiez Zannad, Derek Cyr, Kevin J Anstrom, Irina Barash, Marc P Bonaca, Stefano Corda, Anique Ducharme, Justin Ezekowitz, Anuradha Lala, Carolyn S P Lam, Eldrin F Lewis, JoAnn Lindenfeld, Ciaran J McMullan, Robert J Mentz, Marco Metra, Alanna A Morris, Christopher M O'Connor, Piotr Ponikowski, Yogesh N V Reddy, Giuseppe Rosano, Clara Saldarriaga, Michele Senni, James Udelson, Adriaan A Voors, Javed Butler
{"title":"Mortality benefit and lifetime survival gains with vericiguat in HFrEF: Bayesian and actuarial analyses of the VICTOR trial.","authors":"Francesco Fioretti, Faiez Zannad, Derek Cyr, Kevin J Anstrom, Irina Barash, Marc P Bonaca, Stefano Corda, Anique Ducharme, Justin Ezekowitz, Anuradha Lala, Carolyn S P Lam, Eldrin F Lewis, JoAnn Lindenfeld, Ciaran J McMullan, Robert J Mentz, Marco Metra, Alanna A Morris, Christopher M O'Connor, Piotr Ponikowski, Yogesh N V Reddy, Giuseppe Rosano, Clara Saldarriaga, Michele Senni, James Udelson, Adriaan A Voors, Javed Butler","doi":"10.1093/ejhf/xuag267","DOIUrl":"https://doi.org/10.1093/ejhf/xuag267","url":null,"abstract":"<p><strong>Background: </strong>The VICTOR trial did not meet its primary composite endpoint of cardiovascular death or first hospitalization for heart failure (HF) but demonstrated a nominally significant reduction in the prespecified and powered endpoint of cardiovascular death with vericiguat in patients with HF and reduced ejection fraction (HFrEF). Bayesian and actuarial methods offer complementary frameworks to quantify the probability and lifetime implications of this mortality benefit.</p><p><strong>Methods: </strong>This post hoc analysis of the VICTOR trial applied Bayesian and actuarial analyses. Bayesian analysis estimated the probability that vericiguat reduces mortality, integrating trial data with prior evidence. Actuarial analysis used restricted mean survival time (RMST) to quantify event-free survival at 1 and 2 years, and age-based Cox proportional hazards modelling to project lifetime survival gains across ages 45-80.</p><p><strong>Results: </strong>Bayesian analyses showed a consistently high probability of mortality benefit with vericiguat, regardless of whether sceptical or optimistic prior evidence was weighted. For cardiovascular mortality, the sceptical prior yielded a 98.4% posterior probability of any benefit, a 77.6% probability of at least a 10% relative reduction, and a 20.4% probability of at least a 20% reduction. The VICTORIA-based optimistic prior yielded 99.1%, 60.7%, and 2.2%, respectively. Similar results were observed for all-cause mortality. Actuarial analyses demonstrated greater event-free survival with vericiguat over 1 and 2 years. Lifetime projections suggested that vericiguat may extend overall survival across a broad age range, with the largest gains observed of ∼1.6 to 1.9 years for those aged 55 to 60 at randomization.</p><p><strong>Conclusion: </strong>In this post hoc analysis, Bayesian and actuarial methods provided hypothesis-generating evidence of a cardiovascular mortality benefit with vericiguat in HFrEF, an endpoint for which the trial was prospectively powered, that warrants prospective confirmation.</p>","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":" ","pages":""},"PeriodicalIF":10.3,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148981768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Eugene Braunwald: the father of modern cardiology. 尤金·布劳恩瓦尔德现代心脏病学之父。
IF 10.3 1区 医学
European Journal of Heart Failure Pub Date : 2026-09-15 DOI: 10.1093/ejhf/xuag159
Frank Ruschitzka, Marc A Pfeffer
{"title":"Eugene Braunwald: the father of modern cardiology.","authors":"Frank Ruschitzka, Marc A Pfeffer","doi":"10.1093/ejhf/xuag159","DOIUrl":"10.1093/ejhf/xuag159","url":null,"abstract":"","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":" ","pages":"416-418"},"PeriodicalIF":10.3,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147863335","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Hemodynamic changes in response to GLP-1 treatment in ICD and CRT patients: insights from HeartLogic sensor data. ICD和CRT患者对GLP-1治疗反应的血流动力学变化:来自心脏逻辑传感器数据的见解。
IF 10.3 1区 医学
European Journal of Heart Failure Pub Date : 2026-09-15 DOI: 10.1093/ejhf/xuag114
Frederik Holme Fussing, Lise Witten Davodian, Danny Witten Davodian, Niklas Dyrby Johansen, Preman Kumarathurai, Daniel Modin, Stefan Sattler, Charlotte Larroudé, Niels Risum, Michael Vinther, Lars Køber, Kasper Rossing, Mads Ersbøll, Mikael Kjær Poulsen, Brian Bridal Løgstrup, Katja Fiedler Holm, Ketil J Haugan, Christopher Chien, Brian Claggett, Scott Solomon, Marat Fudim, Adrian Hernandez, Tarek Bekfani, Jens Brock Johansen, Jens Cosedis Nielsen, Craig M Stolen, Tor Biering-Sørensen
{"title":"Hemodynamic changes in response to GLP-1 treatment in ICD and CRT patients: insights from HeartLogic sensor data.","authors":"Frederik Holme Fussing, Lise Witten Davodian, Danny Witten Davodian, Niklas Dyrby Johansen, Preman Kumarathurai, Daniel Modin, Stefan Sattler, Charlotte Larroudé, Niels Risum, Michael Vinther, Lars Køber, Kasper Rossing, Mads Ersbøll, Mikael Kjær Poulsen, Brian Bridal Løgstrup, Katja Fiedler Holm, Ketil J Haugan, Christopher Chien, Brian Claggett, Scott Solomon, Marat Fudim, Adrian Hernandez, Tarek Bekfani, Jens Brock Johansen, Jens Cosedis Nielsen, Craig M Stolen, Tor Biering-Sørensen","doi":"10.1093/ejhf/xuag114","DOIUrl":"10.1093/ejhf/xuag114","url":null,"abstract":"<p><strong>Background: </strong>Glucagon-like peptide-1 receptor agonist (GLP-1RA) therapy is increasingly used, but the physiological effects in patients with heart failure and reduced ejection fraction (HFrEF) remain uncertain. Continuously collected data from implantable cardiac devices may enable evaluation of drug effects in a real-world setting.</p><p><strong>Methods: </strong>In a nationwide Danish retrospective matched cohort study, GLP-1RA initiators with implantable cardiac devices were matched 1:5 to unexposed device recipients by sex and age. Sensor data were assessed from 30 days before to 30 days after initiation. Primary outcomes were changes in heart rate and thoracic impedance. Analyses were adjusted for baseline sensor value, BMI category, hypertension, and type 2 diabetes. Prespecified subgroup analyses were performed in patients with HFrEF.</p><p><strong>Results: </strong>In 666 patients (111 GLP-1RA initiators, 555 matched controls), semaglutide was used in 95% of initiators. Compared with controls, GLP-1RA initiation was associated with higher night heart rate (adjusted difference 2.12 bpm; 95% CI, 1.38-2.87), higher daily heart rate (1.46 bpm; 95% CI, 0.65-2.06), and higher thoracic impedance (0.66 Ω; 95% CI, 0.17-1.15) (all P < .01). S1 amplitude decreased (-0.09 mG; 95% CI, -0.14 to -0.04; P < .01). Heart rate increases followed a stepwise pattern across semaglutide dose levels, with an average increase of 2.5 bpm per dose escalation. Findings were directionally consistent in patients with HFrEF (GLP-1RA n = 80), with no evidence of effect modification.</p><p><strong>Conclusion: </strong>GLP-1RA initiation was associated with measurable changes in device-derived physiology. Larger studies are needed to evaluate clinical implications, including in HFrEF.</p>","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":" ","pages":"546-554"},"PeriodicalIF":10.3,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147696951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Finerenone and quality of life in heart failure: component-level analyses and clinical relevance of the Kansas City cardiomyopathy questionnaire. 芬烯酮和心衰患者的生活质量:堪萨斯城心肌病问卷的成分水平分析和临床相关性。
IF 10.3 1区 医学
European Journal of Heart Failure Pub Date : 2026-09-15 DOI: 10.1093/ejhf/xuag062
Yasuhiro Hamatani, Alexander Peikert, Brian L Claggett, Akshay S Desai, Pardeep S Jhund, Alasdair D Henderson, Carolyn S P Lam, Michele Senni, Sanjiv J Shah, Adriaan A Voors, Faiez Zannad, Bertram Pitt, James Lay-Flurrie, Andrea Lage, Lucas Hofmeister, John J V McMurray, Scott D Solomon, Muthiah Vaduganathan
{"title":"Finerenone and quality of life in heart failure: component-level analyses and clinical relevance of the Kansas City cardiomyopathy questionnaire.","authors":"Yasuhiro Hamatani, Alexander Peikert, Brian L Claggett, Akshay S Desai, Pardeep S Jhund, Alasdair D Henderson, Carolyn S P Lam, Michele Senni, Sanjiv J Shah, Adriaan A Voors, Faiez Zannad, Bertram Pitt, James Lay-Flurrie, Andrea Lage, Lucas Hofmeister, John J V McMurray, Scott D Solomon, Muthiah Vaduganathan","doi":"10.1093/ejhf/xuag062","DOIUrl":"10.1093/ejhf/xuag062","url":null,"abstract":"<p><strong>Aims: </strong>Finerenone was shown to improve overall health status, as measured by the aggregate 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ) score, in heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF). This study aimed to contextualize KCCQ changes in a manner that is relevant to patients and clinicians, thereby improving understanding of this metric in HFmrEF/HFpEF.</p><p><strong>Methods and results: </strong>In this prespecified analysis of FINEARTS-HF, a double-blind, randomized, placebo-controlled trial of finerenone in HFmrEF/HFpEF, we performed exploratory assessments of treatment effects on mean score changes from baseline to 12 months for each of the 23 KCCQ components (scaled from 0 [worst] to 100 [best]) using multivariable linear regression. We further compared the impact of finerenone on the KCCQ-overall summary score (KCCQ-OSS) at 12 months with the expected decline per year. Of 6001 participants in FINEARTS-HF, 5006 completed the KCCQ both at baseline and 12 months (age: 72 ± 10 years, women: 45%, baseline KCCQ-OSS: 63.9 ± 22.0). Finerenone, compared with placebo, numerically improved all but one KCCQ component, with the greatest nominal improvement observed in lower limb oedema frequency (+2.5, 95% CI: 0.9-4.1), fatigue burden (+2.2, 95% CI: 0.9-3.5), fatigue frequency (+2.1, 95% CI: 0.7-3.6), and lower limb oedema burden (+1.8, 95% CI: 0.6-2.9). KCCQ-OSS at 12 months was inversely related to age, with finerenone shifting the age-KCCQ-OSS relationship by 4.7 (95% CI: 0.4-9.1) years.</p><p><strong>Conclusions: </strong>In FINEARTS-HF, finerenone was associated with modest improvements in health status-most notably lower limb oedema and fatigue-in patients with HFmrEF/HFpEF.</p>","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":" ","pages":"460-470"},"PeriodicalIF":10.3,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147429750","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Proteomic patterns according to ejection fraction: an EMPEROR-programme analysis. 蛋白质组学模式根据射血分数:一个皇帝程序分析。
IF 10.3 1区 医学
European Journal of Heart Failure Pub Date : 2026-09-15 DOI: 10.1093/ejhf/xuag013
João Pedro Ferreira, Francesco Fioretti, Mikhail Sumin, Stefan D Anker, Gerasimos Filippatos, Manuel Monroy Kuhn, Marina Panova-Noeva, Jürgen Prochaska, Maral Saadati, Britta Stolze, Cordula Zeller, Faiez Zannad, Javed Butler
{"title":"Proteomic patterns according to ejection fraction: an EMPEROR-programme analysis.","authors":"João Pedro Ferreira, Francesco Fioretti, Mikhail Sumin, Stefan D Anker, Gerasimos Filippatos, Manuel Monroy Kuhn, Marina Panova-Noeva, Jürgen Prochaska, Maral Saadati, Britta Stolze, Cordula Zeller, Faiez Zannad, Javed Butler","doi":"10.1093/ejhf/xuag013","DOIUrl":"10.1093/ejhf/xuag013","url":null,"abstract":"<p><strong>Aims: </strong>Left ventricular ejection fraction (LVEF) has been incorporated as an inclusion criterion in HF trials. Patient's characteristics, event risk, and treatment response vary according to LVEF. A better understanding of the biological processes across LVEF is warranted. To study proteomic biomarker expression across LVEF using data from the EMPEROR-Programme.</p><p><strong>Methods: </strong>Two thousand two hundred and fifty-four patients who had proteomic measurements available using 1134 proteins overlapping between the Explore 1536 and 3072 Olink® platforms were included. Main analyses were performed within the EMPEROR-Preserved dataset due to differences in entry criteria between EMPEROR-Preserved and EMPEROR-Reduced with higher entry N-terminal pro B-type natriuretic peptide (NT-proBNP) levels that varied by LVEF cut-offs in the latter. Protein concentrations were compared using ordinal logistic regression across LVEF categories: 41%-49%, 50%-59%, and ≥60%. The resulting β-coefficient indicates the change in the log-odds for the outcome of being in a lower LVEF category for every NPX unit in log2 scale. Analyses were adjusted for covariates and a false-discovery-rate (FDR) correction was applied.</p><p><strong>Results: </strong>A total of 297 proteins exhibited a trend of expression across LVEF categories in EMPEROR-Preserved after adjustment for potential confounders and correction for test multiplicity. Of these, the top 10 proteins were: NT-pro BNP (β = 0.18, 95% CI 0.09-0.27), Wnt inhibitory factor-1 (β = 0.40, 95% CI 0.19-0.61), sialomucin core protein 24 (β = 0.48, 95% CI 0.22-0.74), phospholipid transfer protein (β = 0.38, 95% CI 0.17-0.59), natriuretic peptides B (β = 0.13, 95% CI 0.06-0.20), intercellular adhesion molecule 5 (β = 0.31, 95% CI 0.14-0.49), neural cell adhesion molecule 2 (β = 0.45, 95% CI 0.19-0.70), neural cell adhesion molecule L1-like protein (β = 0.45, 95% CI 0.19-0.71), interactor protein for cytohesin exchange factors 1 (β = 0.12, 95% CI 0.05-0.19), and 3-ketoacyl-CoA thiolase, peroxisomal (β = 0.17, 95% CI 0.07-0.26). The correlation between these proteins and LVEF was generally weak (Rho ≤0.2).</p><p><strong>Conclusions: </strong>Within EMPEROR-Preserved, the top differentially expressed circulating proteins suggest that pathways related to natriuretic peptides, cell-adhesion, and clonal haematopoiesis are overexpressed at mildly-reduced ejection fraction, but none of the proteins passed the 5%FDR cut-off, and the correlation between circulating proteins and LVEF was weak. These findings suggest that circulating proteins may not be a good discriminant of ejection fraction.</p>","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":" ","pages":"425-432"},"PeriodicalIF":10.3,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343103","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Rationale and design of a randomized, sham-controlled, clinical trial for evaluation of the Edwards APTURE transcatheter shunt system (ALT-FLOW II). 一项评估Edwards APTURE经导管分流系统(ALT-FLOW II)的随机、假对照临床试验的基本原理和设计
IF 10.3 1区 医学
European Journal of Heart Failure Pub Date : 2026-09-15 DOI: 10.1093/ejhf/xuaf016
Dean J Kereiakes, Ryan J Tedford, JoAnn Lindenfeld, William Gray, Firas Zahr, Phillip Lurz, Benjamin Hibbert, Suzanne J Baron, João L Cavalcante, Ulrich P Jorde, John R Teerlink, Rami Kahwash, Scott M Lilly, Michael Böhm, Stephan Windecker, Javed Butler, Robert A Harrington
{"title":"Rationale and design of a randomized, sham-controlled, clinical trial for evaluation of the Edwards APTURE transcatheter shunt system (ALT-FLOW II).","authors":"Dean J Kereiakes, Ryan J Tedford, JoAnn Lindenfeld, William Gray, Firas Zahr, Phillip Lurz, Benjamin Hibbert, Suzanne J Baron, João L Cavalcante, Ulrich P Jorde, John R Teerlink, Rami Kahwash, Scott M Lilly, Michael Böhm, Stephan Windecker, Javed Butler, Robert A Harrington","doi":"10.1093/ejhf/xuaf016","DOIUrl":"10.1093/ejhf/xuaf016","url":null,"abstract":"<p><strong>Aims: </strong>Heart failure (HF) with preserved (HFpEF) and mildly reduced (HFmrEF) ejection fraction are prevalent, yet frequently underdiagnosed syndromes associated with high morbidity and mortality, impaired quality of life, and escalating healthcare expenditures. Although guideline-directed medications like SGLT2 inhibitors have been shown to reduce the risk of hospitalization and cardiovascular death, their use remains limited and substantial residual risk persists. This trial aims to evaluate the safety and performance of a novel left-atrium-to-coronary-sinus shunt (Edwards APTURE transcatheter shunt system) in HFpEF and HFmrEF patients.</p><p><strong>Methods: </strong>ALT-FLOW II is a prospective multi-centre, randomized, sham-controlled, double-blinded (patient and assessor) trial. Approximately 100 symptomatic HF patients aged ≥18 years with left ventricular ejection fraction >40% and exercise pulmonary capillary wedge pressure (PCWP) ≥25 mm Hg with a PCWP to right atrial pressure gradient ≥8 mm Hg will be randomized 1:1 to the APTURE shunt vs sham control. Key exclusion criteria include severe HF, significant valvular disease, and more than mild right ventricular dysfunction. The primary endpoints are the safety of the APTURE device at 30 days and change in workload-corrected PCWP normalized to bodyweight at 6 months. Secondary endpoints include changes in patient-reported outcomes, and hemodynamic and echocardiographic parameters through 5 years. The trial will also explore the impact of the device on short-term cardiac remodelling and intra-cardiac flow patterns using multi-modality imaging.</p><p><strong>Conclusions: </strong>The ALT-FLOW II trial will evaluate the safety and performance of the APTURE system in symptomatic HFpEF and HFmrEF patients with elevated left atrial pressure.</p>","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":" ","pages":"563-571"},"PeriodicalIF":10.3,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343202","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Ziltivekimab in heart failure with preserved and mildly reduced ejection fraction: rationale and design of the ATHENA and HERMES trials. Ziltivekimab治疗心力衰竭并保留和轻度降低射血分数:ATHENA和HERMES试验的基本原理和设计
IF 10.3 1区 医学
European Journal of Heart Failure Pub Date : 2026-09-15 DOI: 10.1093/ejhf/xuag153
Guiomar Mendieta, Paul M Ridker, Barry A Borlaug, Anique Ducharme, Carolyn S P Lam, Adriaan A Voors, Pernille Auerbach, Maja Cikes, Marat Fudim, Anders Hvelplund, Marie Mide Michelsen, Mark C Petrie
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