European Journal of Heart Failure最新文献

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Kidney injury in patients with heart failure‐related cardiogenic shock: Results from an international, multicentre cohort study 心衰相关心源性休克患者肾损伤:一项国际多中心队列研究结果
IF 18.2 1区 医学
European Journal of Heart Failure Pub Date : 2025-05-29 DOI: 10.1002/ejhf.3701
Jonas Sundermeyer, Caroline Kellner, Benedikt N. Beer, Lisa Besch, Angela Dettling, Letizia Fausta Bertoldi, Stefan Blankenberg, Jeroen Dauw, Dennis Eckner, Ingo Eitel, Tobias Graf, Patrick Horn, Joanna Jozwiak‐Nozdrzykowska, Paulus Kirchhof, Stefan Kluge, Axel Linke, Ulf Landmesser, Enzo Lüsebrink, Nicolas Majunke, Norman Mangner, Sven Möbius Winkler, Peter Nordbeck, Martin Orban, Federico Pappalardo, Matthias Pauschinger, Michal Pazdernik, Alastair Proudfoot, Matthew Kelham, Tienush Rassaf, Hermann Reichenspurner, Clemens Scherer, P. Christian Schulze, Robert H.G. Schwinger, Carsten Skurk, Marek Sramko, Guido Tavazzi, Holger Thiele, Luca Villanova, Nuccia Morici, Ephraim B. Winzer, Dirk Westermann, Benedikt Schrage
{"title":"Kidney injury in patients with heart failure‐related cardiogenic shock: Results from an international, multicentre cohort study","authors":"Jonas Sundermeyer, Caroline Kellner, Benedikt N. Beer, Lisa Besch, Angela Dettling, Letizia Fausta Bertoldi, Stefan Blankenberg, Jeroen Dauw, Dennis Eckner, Ingo Eitel, Tobias Graf, Patrick Horn, Joanna Jozwiak‐Nozdrzykowska, Paulus Kirchhof, Stefan Kluge, Axel Linke, Ulf Landmesser, Enzo Lüsebrink, Nicolas Majunke, Norman Mangner, Sven Möbius Winkler, Peter Nordbeck, Martin Orban, Federico Pappalardo, Matthias Pauschinger, Michal Pazdernik, Alastair Proudfoot, Matthew Kelham, Tienush Rassaf, Hermann Reichenspurner, Clemens Scherer, P. Christian Schulze, Robert H.G. Schwinger, Carsten Skurk, Marek Sramko, Guido Tavazzi, Holger Thiele, Luca Villanova, Nuccia Morici, Ephraim B. Winzer, Dirk Westermann, Benedikt Schrage","doi":"10.1002/ejhf.3701","DOIUrl":"https://doi.org/10.1002/ejhf.3701","url":null,"abstract":"AimsHeart failure–related cardiogenic shock (HF‐CS) accounts for about half of CS cases, with a paucity of data regarding the role of kidney injury in this subset. This study aims to evaluate patient characteristics and outcome associated with renal function in patients with HF‐CS.Methods and resultsIn this multicentre, international, retrospective study, patients with HF‐CS from 16 tertiary care centres in five countries were enrolled between 2010 and 2021. To investigate differences in clinical presentation, complications, and 30‐day mortality, based on renal function, adjusted logistic and Cox regression models were fitted. Among 1010 HF‐CS patients, the median age was 64 (interquartile range [IQR] 52–75) years, with 71.7% being male. Median baseline creatinine was 1.7 (IQR 1.2–2.5) mg/dl, corresponding to an estimated glomerular filtration rate (eGFR) of 41.0 (IQR 25.2–62.2) ml/min/1.73 m<jats:sup>2</jats:sup>. In patients with acute kidney injury (AKI), 30‐day mortality increased with AKI stages (no AKI 41.7%, AKI stage 1 43.3%, AKI stage 2 50.0%, AKI stage 3 63.7%; adjusted hazard ratio [HR] for AKI stage 3 1.97, 95% confidence interval [CI] 1.56–2.48, <jats:italic>p</jats:italic> &lt; 0.001). Similarly, severe renal dysfunction (eGFR ≤ median) was associated with a 21% higher 30‐day mortality risk (61.0% vs. 40.1%; adjusted HR 1.48, 95% CI 1.20–1.84, <jats:italic>p</jats:italic> &lt; 0.001). Sepsis and bleeding were associated with both AKI and renal dysfunction, even after adjustment.ConclusionsIn HF‐CS, kidney injury is associated with higher 30‐day mortality, potentially mediated by bleeding and sepsis. These findings support the consideration of kidney function as a prognostic marker and call for the development and evaluation of kidney‐restoring adjunct interventions in HF‐CS.","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":"58 1","pages":""},"PeriodicalIF":18.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144164857","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
Global heart failure epidemiology versus enrolment in pivotal trials: A formidable mismatch 全球心力衰竭流行病学与关键试验的纳入:一个可怕的不匹配
IF 18.2 1区 医学
European Journal of Heart Failure Pub Date : 2025-05-29 DOI: 10.1002/ejhf.3707
Guillaume Baudry, Guowei Li, Ruoting Wang, Rebecca A.V. Newton, Luca Monzo, Nicolas Girerd, Ana Mocumbi, Faiez Zannad, Harriette G. C. Van Spall
{"title":"Global heart failure epidemiology versus enrolment in pivotal trials: A formidable mismatch","authors":"Guillaume Baudry, Guowei Li, Ruoting Wang, Rebecca A.V. Newton, Luca Monzo, Nicolas Girerd, Ana Mocumbi, Faiez Zannad, Harriette G. C. Van Spall","doi":"10.1002/ejhf.3707","DOIUrl":"https://doi.org/10.1002/ejhf.3707","url":null,"abstract":"AimsRandomized clinical trials (RCTs) that inform international clinical practice guidelines should adequately represent regions burdened with disease. We aimed to assess the geographic representativeness of pivotal heart failure (HF) RCTs using two methodological approaches.Methods and resultsWe assessed the global geographic distribution of HF cases using the Global Burden of Disease 2021 dataset. We then assessed the geographic representativeness of pivotal phase 3 RCTs that have shaped international guidelines using two metrics: the representation index (RI), a ratio of regional trial sites to disease distribution, and the participant‐to‐prevalence ratio (PPR), a ratio of regional trial participants to disease distribution. In 2021, there were 55.4 million people with HF worldwide, with the greatest population in Asia (50%), followed by Europe (18%), Africa (14%), North America (10%), and Central &amp; South America (8%). PPR estimates were limited by the variation in how trials classified regions when reporting participant enrolment. Yet, RI and PPR estimates revealed similar estimates of geographic representation. Europe (RI: 2.41, PPR: 2.69) and North America (RI: 3.25, PPR: 2.58) were over‐represented in trials, while Asia (RI: 0.26, PPR: 0.22) and Africa (RI: 0.14, PPR: 0.05) were grossly under‐represented. In contrast, Central &amp; South America (RI: 1.29, PPR: 1.59) were adequately represented.ConclusionsPivotal HF RCTs generate evidence primarily from Europe and North America, and grossly under‐represent Africa and Asia. RI and PPR are correlated measures of regional representativeness, highlighting that regional participant enrolment is related to the number of trial sites in a region. Unlike PPR, RI can be estimated during trial planning and guide trial design for better regional representativeness.","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":"17 1","pages":""},"PeriodicalIF":18.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144164928","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
Albuminuria as a diagnostic criterion and a therapeutic target in heart failure and other cardiovascular disease 蛋白尿作为心衰和其他心血管疾病的诊断标准和治疗靶点
IF 18.2 1区 医学
European Journal of Heart Failure Pub Date : 2025-05-28 DOI: 10.1002/ejhf.3683
Biykem Bozkurt, Patrick Rossignol, Joseph A. Vassalotti
{"title":"Albuminuria as a diagnostic criterion and a therapeutic target in heart failure and other cardiovascular disease","authors":"Biykem Bozkurt, Patrick Rossignol, Joseph A. Vassalotti","doi":"10.1002/ejhf.3683","DOIUrl":"https://doi.org/10.1002/ejhf.3683","url":null,"abstract":"The high disease burden and bidirectional relationship of chronic kidney disease (CKD), heart failure (HF) and other cardiovascular disease (CVD) necessitate the need for early diagnosis of these diseases. While current screening and detection methods are recommended by CKD and CVD guidelines, their adoption in practice is low. Urine albumin‐to‐creatinine ratio (uACR) is recognized as a diagnostic marker for CKD and a prognostic marker for CKD progression, HF and CVD outcomes, therefore albuminuria changes have been accepted as a surrogate outcome for kidney and cardiovascular endpoints. Furthermore, clinical trials investigating guideline‐directed medical therapies have shown that uACR reductions are accompanied by risk reductions for cardiovascular, HF and other CKD outcomes. However, uACR is not routinely measured in patients at risk of kidney and heart disease, and its utility for detection, risk stratification and prediction models may not be fully appreciated in routine clinical practice. This review will discuss the effectiveness and implications of uACR screening as a method for heart and kidney disease diagnosis and risk assessment.","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":"239 1","pages":""},"PeriodicalIF":18.2,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144153362","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
Clinical and financial implications of inpatient and outpatient management of worsening heart failure 心衰恶化的住院和门诊管理的临床和财务意义
IF 18.2 1区 医学
European Journal of Heart Failure Pub Date : 2025-05-27 DOI: 10.1002/ejhf.3702
Stephen J. Greene, Lisa A. Kaltenbach, Gregg C. Fonarow, Karen Chiswell, Veraprapas Kittipibul, Hubert B. Haywood, Muhammad Shahzeb Khan, Bradley G. Hammill, Javed Butler, Adrian F. Hernandez, G. Michael Felker
{"title":"Clinical and financial implications of inpatient and outpatient management of worsening heart failure","authors":"Stephen J. Greene, Lisa A. Kaltenbach, Gregg C. Fonarow, Karen Chiswell, Veraprapas Kittipibul, Hubert B. Haywood, Muhammad Shahzeb Khan, Bradley G. Hammill, Javed Butler, Adrian F. Hernandez, G. Michael Felker","doi":"10.1002/ejhf.3702","DOIUrl":"https://doi.org/10.1002/ejhf.3702","url":null,"abstract":"AimsLittle is known regarding the clinical and financial implications of varying inpatient and outpatient management strategies for worsening heart failure (WHF). This analysis aimed to compare clinical outcomes, home‐time, and healthcare expenditure following various types of inpatient and outpatient WHF events in US clinical practice.Methods and resultsWe examined US Medicare beneficiaries 65 years and older discharged from a hospitalization for heart failure (HF) in the Get With The Guidelines‐Heart Failure registry from 2010 to 2018. Patients developing subsequent WHF within 12 months were divided into four mutually exclusive groups by type of first event: HF hospitalization, emergency department (ED) visit with ED discharge, observation stay, and outpatient intravenous (IV) diuretic clinic visit. Following each type of WHF event, mortality, home‐time (days alive and out of any healthcare institution), and healthcare costs were compared over the subsequent 12 months. Among 181 827 eligible patients discharged alive from a HF hospitalization across 553 US hospitals, 61 159 (33.6%) patients had a subsequent WHF event within 12 months. Of these, 48 612 were managed with HF hospitalization (79.5%), 8139 (13.3%) with an ED visit, 1767 (2.9%) with an observation stay, and 2641 (4.3%) with an outpatient IV diuretic visit. Rates of 12‐month mortality were highest following HF hospitalization (cumulative incidence rate [IR] 48.8; 95% confidence interval [CI] 48.3–49.3), lowest following observation unit stay (IR 29.9; 95% CI 27.7–32.0), and intermediate following ED discharge (IR 41.2; 95% CI 40.1–42.3) and outpatient IV diuretic visit (IR 39.3; 95% CI 37.4–41.2). Median (25th–75th) 12‐month home‐time was lowest following HF hospitalization (251 [47–351] days) and highest following observation unit stays (354 [206–365] days). For the index WHF event itself, median total per‐patient costs were highest for HF hospitalization (US$11 335) and lowest for outpatient IV diuretic visit (US$259). Over the 12 months following the WHF event, when accounting for costs of all patients including those who died within 12 months, the median total per‐patient costs were highest following outpatient IV diuretic visits (US$29 173). Among patients surviving 12 months after WHF, median total per‐patient costs following an outpatient IV diuretic visit (US$29 931) versus HF hospitalization (US$30 971) were similarly high.ConclusionsIn this nationwide analysis of older US adults, high rates of death and substantial reductions in home‐time occurred following WHF regardless of inpatient or outpatient management, but were worse following HF hospitalization. Outpatient IV diuretic administration was the least expensive initial management strategy, but over the subsequent 12 months, associated costs were similar or higher than costs following HF hospitalization.","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":"18 1","pages":""},"PeriodicalIF":18.2,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144145516","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
What's new in heart failure? May 2025 心力衰竭有什么新进展?2025年5月
IF 16.9 1区 医学
European Journal of Heart Failure Pub Date : 2025-05-25 DOI: 10.1002/ejhf.3685
Mert Tokcan, Julian Hoevelmann, Philipp Markwirth, Bernhard Haring
{"title":"What's new in heart failure? May 2025","authors":"Mert Tokcan,&nbsp;Julian Hoevelmann,&nbsp;Philipp Markwirth,&nbsp;Bernhard Haring","doi":"10.1002/ejhf.3685","DOIUrl":"https://doi.org/10.1002/ejhf.3685","url":null,"abstract":"","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":"27 5","pages":"743-746"},"PeriodicalIF":16.9,"publicationDate":"2025-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144135552","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
Longitudinal blood pressure and cardiovascular outcomes in heart failure: An individual patient data pooling analysis of clinical trials 心力衰竭的纵向血压和心血管结局:临床试验的个体患者数据池分析
IF 18.2 1区 医学
European Journal of Heart Failure Pub Date : 2025-05-24 DOI: 10.1002/ejhf.3706
Jing-Wei Li, Jiang Wang, Yunlong Chen, Hao Yang, Yi Wang, Xia Wang, Jingjng Xiao, Ying Wang, Dehui Qian, Shiyong Yu, Xiaohui Zhao, Hu Tan, Jun Jin, Xin Du, Craig S. Anderson
{"title":"Longitudinal blood pressure and cardiovascular outcomes in heart failure: An individual patient data pooling analysis of clinical trials","authors":"Jing-Wei Li, Jiang Wang, Yunlong Chen, Hao Yang, Yi Wang, Xia Wang, Jingjng Xiao, Ying Wang, Dehui Qian, Shiyong Yu, Xiaohui Zhao, Hu Tan, Jun Jin, Xin Du, Craig S. Anderson","doi":"10.1002/ejhf.3706","DOIUrl":"https://doi.org/10.1002/ejhf.3706","url":null,"abstract":"Previous analyses of the relationship between blood pressure (BP) and heart failure (HF) outcomes have primarily used baseline values rather than longitudinal measurements. We aimed to elucidate associations between longitudinal BP and clinical outcomes in patients with HF with reduced ejection fraction (HFrEF), mildly reduced ejection fraction (HFmrEF), and preserved ejection fraction (HFpEF).","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":"33 1","pages":""},"PeriodicalIF":18.2,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144130117","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
Genotype-guided cardiac device intervention in LMNA-related cardiac conduction disorder: The need for timely genetic testing 基因型引导心脏装置干预lmna相关心脏传导障碍:需要及时进行基因检测
IF 18.2 1区 医学
European Journal of Heart Failure Pub Date : 2025-05-24 DOI: 10.1002/ejhf.3695
Shunsuke Inoue, Zhehao Dai, Tsukasa Oshima, Seitaro Nomura, Takashi Hiruma, Ryo Abe, Kanna Fujita, Manami Katoh, Toshiyuki Ko, Yu Shimizu, Masamichi Ito, Kenichiro Yamagata, Junichi Ishida, Eisuke Amiya, Masaru Hatano, Norifumi Takeda, Hiroyuki Morita, Katsuhito Fujiu, Norihiko Takeda, Issei Komuro
{"title":"Genotype-guided cardiac device intervention in LMNA-related cardiac conduction disorder: The need for timely genetic testing","authors":"Shunsuke Inoue, Zhehao Dai, Tsukasa Oshima, Seitaro Nomura, Takashi Hiruma, Ryo Abe, Kanna Fujita, Manami Katoh, Toshiyuki Ko, Yu Shimizu, Masamichi Ito, Kenichiro Yamagata, Junichi Ishida, Eisuke Amiya, Masaru Hatano, Norifumi Takeda, Hiroyuki Morita, Katsuhito Fujiu, Norihiko Takeda, Issei Komuro","doi":"10.1002/ejhf.3695","DOIUrl":"https://doi.org/10.1002/ejhf.3695","url":null,"abstract":"Sudden cardiac death is a catastrophic event, making its prevention important. However, patient selection for primary prevention remains controversial. We report two cases of cardiac conduction disorder initially treated with permanent pacemaker implantation. Genetic testing later revealed novel pathogenic variants in <i>LMNA</i>, leading to an upgrade to implantable cardioverter-defibrillator for primary prevention of sudden cardiac death. These cases highlight the importance of early genetic analysis to guide optimal device therapy. The delay in obtaining genetic results necessitated reoperation, underscoring the need for preceding genomic sequencing and physician awareness to improve clinical decision-making and patient outcomes.","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":"31 1","pages":""},"PeriodicalIF":18.2,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144130354","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
Renal denervation improves cardiac function and exercise duration in a miniswine model of heart failure with preserved ejection fraction. 在一个保留射血分数的心力衰竭迷你模型中,肾去神经支配改善心功能和运动时间。
IF 18.2 1区 医学
European Journal of Heart Failure Pub Date : 2025-05-22 DOI: 10.1002/ejhf.3700
David J Lefer,Thomas E Sharp,Amy L Scarborough,Amelia G Haydel,Sanjiv J Shah,Zhen Li,Traci T Goodchild
{"title":"Renal denervation improves cardiac function and exercise duration in a miniswine model of heart failure with preserved ejection fraction.","authors":"David J Lefer,Thomas E Sharp,Amy L Scarborough,Amelia G Haydel,Sanjiv J Shah,Zhen Li,Traci T Goodchild","doi":"10.1002/ejhf.3700","DOIUrl":"https://doi.org/10.1002/ejhf.3700","url":null,"abstract":"AIMSOveractivity of the sympathetic nervous system is a common underlying mechanism in development and progression of several heart failure with preserved ejection fraction (HFpEF) comorbidities. Decreasing renal sympathetic nerve activity using catheter-based renal denervation (RDN) systems have shown efficacy in treating resistant hypertension and cardiac dysfunction in heart failure with reduced ejection fraction. The purpose of this study was to determine if modulation of renal sympathetic nerve activity by RDN improves cardiac function and exercise tolerance in a clinically-relevant minipig model of cardiometabolic HFpEF.METHODS AND RESULTSMultiple HFpEF comorbidities were induced in adult female Göttingen minipigs by mineralocorticoid excess and a diet high in cholesterol, fat, fructose, and salt. HFpEF minipigs were randomized to bilateral catheter-RDN (n = 5) treatment or sham-RDN (n = 4). RDN therapy reduced renal sympathetic activity in HFpEF minipigs and increased treadmill exercise duration. Following RDN treatment, sustained improvements in diastolic function including E/e' and left atrial fractional area change were observed. Elevations in resting left ventricular filling and pulmonary pressures in HFpEF minipigs, while indicative of HFpEF severity, were unaffected by RDN treatment. Following RDN treatment, there was a transient reduction in arterial blood pressure and no change in heart rate.CONCLUSIONSDevice-based RDN may be a potential therapeutic strategy to halt the progression of HFpEF by improving cardiac diastolic function and exercise tolerance.","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":"32 1","pages":""},"PeriodicalIF":18.2,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144114215","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
Safety and tolerability of a 5 mg starting dose of vericiguat among patients with heart failure: The VELOCITY study 心衰患者起始剂量5mg vericiguat的安全性和耐受性:VELOCITY研究
IF 18.2 1区 医学
European Journal of Heart Failure Pub Date : 2025-05-20 DOI: 10.1002/ejhf.3699
Stephen J. Greene, Stefano Corda, Ciaran J. McMullan, Giovanni Palombo, Christina Schooss, Vanja Vlajnic, Katrin Walkamp, Michele Senni
{"title":"Safety and tolerability of a 5 mg starting dose of vericiguat among patients with heart failure: The VELOCITY study","authors":"Stephen J. Greene, Stefano Corda, Ciaran J. McMullan, Giovanni Palombo, Christina Schooss, Vanja Vlajnic, Katrin Walkamp, Michele Senni","doi":"10.1002/ejhf.3699","DOIUrl":"https://doi.org/10.1002/ejhf.3699","url":null,"abstract":"AimsIn clinical practice, simplifying the number of medication titration steps while maintaining safety may improve the likelihood of patients with heart failure (HF) achieving target doses of guideline‐directed medical therapy (GDMT). The VELOCITY study examined whether removing the 2.5 mg initiation step for vericiguat, and instead initiating therapy at 5 mg daily, would be safe and well‐tolerated.Methods and resultsVELOCITY was a prospective, 2‐week, single‐arm, open‐label phase 2b study that enrolled patients with chronic HF with ejection fraction &lt;45%, with or without a recent (≤6 or &gt;6 months) worsening HF (WHF) event. Patients with systolic blood pressure &lt;100 mmHg, recent symptomatic hypotension, and recent change in background GDMT or diuretic dosing were excluded. Participants were initiated on vericiguat 5 mg daily and followed for the primary endpoint, defined as completion of 2‐week period with maximum 1‐day interruption and without moderate to severe symptomatic hypotension between Visit 1 (Day 1) and Visit 2 (Day 14). Among 106 study patients (mean age 67 years, 28% female), 50% had recent WHF. Background GDMT included 54% prescribed angiotensin receptor–neprilysin inhibitors and 81% prescribed sodium–glucose cotransporter 2 inhibitors. The primary tolerability endpoint was met in 93.4% of patients, including 90.6% of patients in the WHF group and 96.2% of patients in the non‐WHF group. Tolerability of initiating vericiguat 5 mg was generally consistent across the pre‐specified sensitivity and secondary endpoints. When comparing patients initiating vericiguat 2.5 mg daily in VICTORIA with those starting vericiguat 5 mg daily in VELOCITY, the proportion meeting the VELOCITY primary tolerability endpoint was 97.2% in VICTORIA versus 93.4% in VELOCITY.ConclusionsIn the prospective VELOCITY study of patients with chronic HF with ejection fraction &lt;45% who were well‐treated with background GDMT, &gt;9 of 10 patients safely tolerated initiation of vericiguat at the 5 mg/day dose. Findings were generally consistent regardless of recent history of WHF. In the context of safety and tolerability data from prior vericiguat studies, VELOCITY supports a potential update in clinical guidance to include a 5 mg starting dose of vericiguat among patients without recent hypotension.Clinical Trials Registration: ClinicalTrials.gov NCT06195930.","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":"97 1","pages":""},"PeriodicalIF":18.2,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144096928","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
Recurrent event analyses in patients receiving maintenance dialysis and the effect of higher- versus lower-dose chronic intravenous iron therapy: A report focusing on heart failure events from the PIVOTAL trial. 接受维持性透析的患者的复发事件分析和高剂量与低剂量慢性静脉铁治疗的影响:一份关于枢纽试验中心力衰竭事件的报告。
IF 18.2 1区 医学
European Journal of Heart Failure Pub Date : 2025-05-20 DOI: 10.1002/ejhf.3670
Stefan D Anker,Michele Robertson,John J V McMurray,Pardeep S Jhund,Claire White,Chante Reid,Sunil Bhandari,Ken Farrington,Philip A Kalra,Khawaja M Talha,Patrick B Mark,Charles R V Tomson,David C Wheeler,Chris G Winearls,Iain C Macdougall,Ian Ford
{"title":"Recurrent event analyses in patients receiving maintenance dialysis and the effect of higher- versus lower-dose chronic intravenous iron therapy: A report focusing on heart failure events from the PIVOTAL trial.","authors":"Stefan D Anker,Michele Robertson,John J V McMurray,Pardeep S Jhund,Claire White,Chante Reid,Sunil Bhandari,Ken Farrington,Philip A Kalra,Khawaja M Talha,Patrick B Mark,Charles R V Tomson,David C Wheeler,Chris G Winearls,Iain C Macdougall,Ian Ford","doi":"10.1002/ejhf.3670","DOIUrl":"https://doi.org/10.1002/ejhf.3670","url":null,"abstract":"AIMSIn the PIVOTAL trial, a proactive high-dose regimen of intravenous iron sucrose, compared to a lower-dose reactive regimen, reduced the risk of first and recurrent events of the primary endpoint in haemodialysis patients. We present the various approaches of recurrent event analyses for the primary endpoint and for the composite of cardiovascular (CV) death or heart failure hospitalization and their non-fatal components.METHODS AND RESULTSPatients were randomized to a proactive maintenance dose of iron sucrose (average 264 mg/month) or a reactive treatment regimen (average 145 mg/month). We compared the results of time-to-first event analyses with recurrent event analysis using the negative binomial model and methods proposed by Wei-Lin-Weissfeld, Andersen and Gill, Lin, Wei, Yang and Ying [LWYY], Mao and Lin, and Rondeau and colleagues. The 2141 haemodialysis patients were followed for a median of 2.1 years and experienced 936 primary recurrent events, which is 42% higher than the number of 658 first events. Proactive regimen patients had 429 primary events (19.4/100 patient-years) compared with 507 events in the reactive regimen patients (24.6/100 patient-years) (rate ratio 0.77, 95% confidence interval [CI] 0.66-0.92, p = 0.0027, LWYY). Recurrent events were also reduced in the proactive regimen for the composite of CV mortality and heart failure hospitalizations (rate ratio 0.73, 95% CI 0.56-0.93, p = 0.013). Recurrent event analyses based on other approaches were very similar to those given above based on the method of LWYY.CONCLUSIONA higher dose of chronic intravenous iron therapy compared to a lower dose substantially reduced the total burden of important recurrent events of death and CV disease in patients with end-stage kidney disease receiving maintenance haemodialysis therapy.","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":"31 1","pages":""},"PeriodicalIF":18.2,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144103773","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}
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