Gracjan Iwanek, Robert Zymliński, Mateusz Guzik, Piotr Gajewski, Julio Nuñez, Rafał Tymków, Jeffrey Testani, Piotr Ponikowski, Jan Biegus
Aims: For many years, fluid and sodium restriction have been considered an essential strategy for achieving effective decongestion in acute heart failure (AHF), but this paradigm has recently been questioned. This analysis aims to evaluate and compare the effectiveness of three different fluid strategies for decongestion: no fluid, fluid with sodium/chloride, and fluid without sodium/chloride in AHF.
Methods: This post-hoc analysis of two prospective, single-centre, mechanistic studies included 55 patients with AHF and fluid overload. All patients received standardized furosemide dosing. A total of 21 patients received a continuous infusion of 0.9% NaCl (83 mL/h), 19 patients received 5% glucose (83 mL/h), and 15 did not receive any fluids. The primary outcome is urine volume and natriuresis at 6 h after loop diuretic administration.
Results: There was a significant difference in cumulative (6 h) net natriuresis between patients receiving fluid therapy (n = 40) and those without fluid therapy (n = 15) (139 [66-264] mmol vs. 79 [15-144] mmol, P = .043). There was no significant difference in cumulative net diuresis between these groups (1170 [880-1890] mL vs. 1010 [475-1270] mL, P = .078), respectively. The NaCl group had a better diuretic response when compared with the glucose and no-fluids groups (absolute: 1980 [1620-3150] mL vs. 1510 [1075-2175] mL vs. 1010 [475-1270] mL, P < .001, net: 1480 [1120-2650] mL vs. 1010 [575-1675] mL vs. 1010 [475-1270] mL, P = .019, respectively) but the difference in natriuresis did not meet statistical significance (P = .126).
Conclusion: Intravenous fluid replacement during decongestion in patients with AHF was associated with increased net natriuresis and a trend towards higher urine output, with a significant augmentation of diuresis with sodium chloride supplementation.
目的:多年来,限制液体和钠被认为是实现急性心力衰竭(AHF)有效去充血的基本策略,但这种模式最近受到质疑。本分析旨在评估和比较AHF患者三种不同的解血方法的有效性:无补液、含钠/氯化物补液和不含钠/氯化物补液。方法:这项对两项前瞻性、单中心、机制研究的事后分析包括55例AHF和液体超载患者。所有患者均接受标准化速尿剂量。21例患者持续输注0.9% NaCl (83 mL/h), 19例患者输注5%葡萄糖(83 mL/h), 15例患者不输注任何液体。主要结果是在利尿剂循环使用后6小时的尿量和尿钠量。结果:接受液体治疗的患者(n = 40)与未接受液体治疗的患者(n = 15)的累计(6小时)净尿钠量差异有统计学意义(139 [66-264]mmol vs. 79 [15-144] mmol, P = 0.043)。两组患者累计净利尿量分别为1170 [880-1890]mL和1010 [475-1270]mL, P = 0.078,差异无统计学意义。与葡萄糖和无液体组相比,NaCl组有更好的利尿效果(绝对值:1980 [1620-3150]mL vs. 1510 [1075-2175] mL vs. 1010 [475-1270] mL, P < 0.001;净值:1480 [1120-2650]mL vs. 1010 [575-1675] mL vs. 1010 [475-1270] mL, P = 0.019),但尿钠量差异无统计学意义(P = 0.126)。结论:AHF患者在去充血期间静脉补液与净尿钠增加和尿量增加相关,并与补充氯化钠显著增强利尿有关。
{"title":"The impact of volume and sodium chloride supplementation on diuretic response during decongestion of decompensated heart failure patients.","authors":"Gracjan Iwanek, Robert Zymliński, Mateusz Guzik, Piotr Gajewski, Julio Nuñez, Rafał Tymków, Jeffrey Testani, Piotr Ponikowski, Jan Biegus","doi":"10.1093/ejhf/xuaf023","DOIUrl":"https://doi.org/10.1093/ejhf/xuaf023","url":null,"abstract":"<p><strong>Aims: </strong>For many years, fluid and sodium restriction have been considered an essential strategy for achieving effective decongestion in acute heart failure (AHF), but this paradigm has recently been questioned. This analysis aims to evaluate and compare the effectiveness of three different fluid strategies for decongestion: no fluid, fluid with sodium/chloride, and fluid without sodium/chloride in AHF.</p><p><strong>Methods: </strong>This post-hoc analysis of two prospective, single-centre, mechanistic studies included 55 patients with AHF and fluid overload. All patients received standardized furosemide dosing. A total of 21 patients received a continuous infusion of 0.9% NaCl (83 mL/h), 19 patients received 5% glucose (83 mL/h), and 15 did not receive any fluids. The primary outcome is urine volume and natriuresis at 6 h after loop diuretic administration.</p><p><strong>Results: </strong>There was a significant difference in cumulative (6 h) net natriuresis between patients receiving fluid therapy (n = 40) and those without fluid therapy (n = 15) (139 [66-264] mmol vs. 79 [15-144] mmol, P = .043). There was no significant difference in cumulative net diuresis between these groups (1170 [880-1890] mL vs. 1010 [475-1270] mL, P = .078), respectively. The NaCl group had a better diuretic response when compared with the glucose and no-fluids groups (absolute: 1980 [1620-3150] mL vs. 1510 [1075-2175] mL vs. 1010 [475-1270] mL, P < .001, net: 1480 [1120-2650] mL vs. 1010 [575-1675] mL vs. 1010 [475-1270] mL, P = .019, respectively) but the difference in natriuresis did not meet statistical significance (P = .126).</p><p><strong>Conclusion: </strong>Intravenous fluid replacement during decongestion in patients with AHF was associated with increased net natriuresis and a trend towards higher urine output, with a significant augmentation of diuresis with sodium chloride supplementation.</p>","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":" ","pages":""},"PeriodicalIF":10.8,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343134","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}
Ross T Campbell, Joanna Osmanska, Kieran F Docherty, Fozia Z Ahmed, Andrew L Clark, Louise Clayton, John G F Cleland, Chris Critoph, Matthew Dewhurst, Nick Hartshorne-Evans, Roy S Gardner, Kate V Gatenby, Kaushik Guha, Paul R Kalra, Andrea Lees, Alex McConnachie, Pieter Muntendam, Kirstie Mowat, Joanne O'Donnell, Anna Placzek, Robin Ray, Henry Oluwasefunmi Savage, Rebeka Schiff, Iain Squire, Kirsty Wetherall, Ken Wong, Chih Wong, John J V McMurray, Mark C Petrie
Introduction: Heart failure (HF) hospitalizations are frequent and lengthy, and usually involve treatment with intravenous diuretics to relieve congestion. SUBCUT HF II is evaluating the safety and efficacy of an alternative ambulatory care strategy using a novel subcutaneous formulation of furosemide delivered via a wearable pump.
Methods: The SUBCUT HF II trial is a multicentre, randomized, active comparator trial involving 20 hospitals in the UK. Eligible participants are patients with HF receiving inpatient treatment with intravenous loop diuretic. Patients are randomized to either early supported discharge, using a novel formulation of subcutaneous furosemide (SQIN-Furosemide) administered by a wearable pump (SQIN-Infusor), or continued inpatient treatment using intravenous furosemide.
Results: The primary endpoint is days spent alive and out of hospital at 30 days. As of October 2025, 168 of 170 patients have been randomized.
Conclusion: The SUBCUT HF II trial is testing the safety and efficacy of an ambulatory care approach to managing patients presenting to the hospital with HF.
{"title":"SUBCUT HF II: rationale and design of a multicentre randomized controlled trial of SUBCUTaneous furosemide to support early discharge in patients admitted to hospital due to Heart Failure.","authors":"Ross T Campbell, Joanna Osmanska, Kieran F Docherty, Fozia Z Ahmed, Andrew L Clark, Louise Clayton, John G F Cleland, Chris Critoph, Matthew Dewhurst, Nick Hartshorne-Evans, Roy S Gardner, Kate V Gatenby, Kaushik Guha, Paul R Kalra, Andrea Lees, Alex McConnachie, Pieter Muntendam, Kirstie Mowat, Joanne O'Donnell, Anna Placzek, Robin Ray, Henry Oluwasefunmi Savage, Rebeka Schiff, Iain Squire, Kirsty Wetherall, Ken Wong, Chih Wong, John J V McMurray, Mark C Petrie","doi":"10.1093/ejhf/xuaf018","DOIUrl":"https://doi.org/10.1093/ejhf/xuaf018","url":null,"abstract":"<p><strong>Introduction: </strong>Heart failure (HF) hospitalizations are frequent and lengthy, and usually involve treatment with intravenous diuretics to relieve congestion. SUBCUT HF II is evaluating the safety and efficacy of an alternative ambulatory care strategy using a novel subcutaneous formulation of furosemide delivered via a wearable pump.</p><p><strong>Methods: </strong>The SUBCUT HF II trial is a multicentre, randomized, active comparator trial involving 20 hospitals in the UK. Eligible participants are patients with HF receiving inpatient treatment with intravenous loop diuretic. Patients are randomized to either early supported discharge, using a novel formulation of subcutaneous furosemide (SQIN-Furosemide) administered by a wearable pump (SQIN-Infusor), or continued inpatient treatment using intravenous furosemide.</p><p><strong>Results: </strong>The primary endpoint is days spent alive and out of hospital at 30 days. As of October 2025, 168 of 170 patients have been randomized.</p><p><strong>Conclusion: </strong>The SUBCUT HF II trial is testing the safety and efficacy of an ambulatory care approach to managing patients presenting to the hospital with HF.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier NCT05419115.</p>","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":" ","pages":""},"PeriodicalIF":10.8,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343101","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}
Francisco Vasques-Nóvoa, João Pedro Ferreira, Jennifer Mâncio, Pedro Marques, Manuela Torrinha, Sandra Martins, João Tiago Guimarães, Jorge Almeida, Fernando Friões, Nuno Bettencourt, Roberto Roncon-Albuquerque, Adelino F Leite-Moreira
{"title":"Myocardial fibrosis in heart failure with preserved ejection fraction: integrating circulating collagen fragments and cardiac magnetic resonance mapping.","authors":"Francisco Vasques-Nóvoa, João Pedro Ferreira, Jennifer Mâncio, Pedro Marques, Manuela Torrinha, Sandra Martins, João Tiago Guimarães, Jorge Almeida, Fernando Friões, Nuno Bettencourt, Roberto Roncon-Albuquerque, Adelino F Leite-Moreira","doi":"10.1093/ejhf/xuaf020","DOIUrl":"https://doi.org/10.1093/ejhf/xuaf020","url":null,"abstract":"","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":" ","pages":""},"PeriodicalIF":10.8,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343164","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}
Li Shen, Liwen Shen, Iokfai Cheang, Wenming Yao, Xu Zhu, Yue Zhang, Ying Yang, Qilin Li, Haifeng Zhang, Mark C Petrie, Carolyn S P Lam, Pardeep S Jhund, John J V McMurray, Xinli Li
Aims: Qiliqiangxin (QLQX), a Chinese traditional medicine, improved outcomes in patients with heart failure and reduced ejection fraction (HFrEF) when added to guideline-directed therapy. As treatment effects in heart failure (HF) may vary with left ventricular ejection fraction (LVEF), this post hoc analysis of the QUEST (Qiliqiangxin in Heart Failure: Assessment of Reduction in Mortality) trial examined whether baseline LVEF modified the efficacy and safety of QLQX.
Methods: QUEST randomized 3110 patients with symptomatic HF and LVEF ≤40%. The primary outcome was cardiovascular death or first HF hospitalization. Baseline LVEF was categorized as ≤25% (n = 482), >25-30% (n = 692), >30-35% (n = 829), and >35% (n = 1107).
Results: Mean LVEF was 32% (median 33%, interquartile range 28%-37%). Patients with LVEF ≤25% had the highest rate of the primary outcome (25.4 per 100 patient-years), while rates were similar across higher LVEF groups (18.7-19.8). After multivariable adjustment, lower LVEF was independently associated with higher risks of the primary outcome and mortality. The effect of QLQX on the primary outcome was consistent across LVEF categories (hazard ratio [95% CI] from the lowest to highest: 0.91 [0.64-1.30], 0.65 [0.47-0.89], 0.94 [0.71-1.26], and 0.71 [0.55-0.91], respectively; Pinteraction = .28), and as a continuous variable (Pinteraction = .45). Similar results were observed for individual components and total HF hospitalizations (all Pinteraction > .10). The safety of QLQX was also consistent across LVEF categories.
Conclusion: In patients with HFrEF, lower LVEF was associated with worse cardiovascular outcomes. QLQX reduced cardiovascular events consistently across the range of LVEF examined in QUEST, despite the limited use of sodium-glucose co-transporter 2 inhibitors.
{"title":"The efficacy and safety of qiliqiangxin according to baseline ejection fraction in patients with heart failure and reduced ejection fraction in QUEST.","authors":"Li Shen, Liwen Shen, Iokfai Cheang, Wenming Yao, Xu Zhu, Yue Zhang, Ying Yang, Qilin Li, Haifeng Zhang, Mark C Petrie, Carolyn S P Lam, Pardeep S Jhund, John J V McMurray, Xinli Li","doi":"10.1093/ejhf/xuaf017","DOIUrl":"https://doi.org/10.1093/ejhf/xuaf017","url":null,"abstract":"<p><strong>Aims: </strong>Qiliqiangxin (QLQX), a Chinese traditional medicine, improved outcomes in patients with heart failure and reduced ejection fraction (HFrEF) when added to guideline-directed therapy. As treatment effects in heart failure (HF) may vary with left ventricular ejection fraction (LVEF), this post hoc analysis of the QUEST (Qiliqiangxin in Heart Failure: Assessment of Reduction in Mortality) trial examined whether baseline LVEF modified the efficacy and safety of QLQX.</p><p><strong>Methods: </strong>QUEST randomized 3110 patients with symptomatic HF and LVEF ≤40%. The primary outcome was cardiovascular death or first HF hospitalization. Baseline LVEF was categorized as ≤25% (n = 482), >25-30% (n = 692), >30-35% (n = 829), and >35% (n = 1107).</p><p><strong>Results: </strong>Mean LVEF was 32% (median 33%, interquartile range 28%-37%). Patients with LVEF ≤25% had the highest rate of the primary outcome (25.4 per 100 patient-years), while rates were similar across higher LVEF groups (18.7-19.8). After multivariable adjustment, lower LVEF was independently associated with higher risks of the primary outcome and mortality. The effect of QLQX on the primary outcome was consistent across LVEF categories (hazard ratio [95% CI] from the lowest to highest: 0.91 [0.64-1.30], 0.65 [0.47-0.89], 0.94 [0.71-1.26], and 0.71 [0.55-0.91], respectively; Pinteraction = .28), and as a continuous variable (Pinteraction = .45). Similar results were observed for individual components and total HF hospitalizations (all Pinteraction > .10). The safety of QLQX was also consistent across LVEF categories.</p><p><strong>Conclusion: </strong>In patients with HFrEF, lower LVEF was associated with worse cardiovascular outcomes. QLQX reduced cardiovascular events consistently across the range of LVEF examined in QUEST, despite the limited use of sodium-glucose co-transporter 2 inhibitors.</p><p><strong>Chictr registration: </strong>ChiCTR1900021929.</p>","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":" ","pages":""},"PeriodicalIF":10.8,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343168","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}
{"title":"The current classification of heart failure is obsolete.","authors":"John E Sanderson, John G F Cleland","doi":"10.1093/ejhf/xuaf010","DOIUrl":"https://doi.org/10.1093/ejhf/xuaf010","url":null,"abstract":"","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":" ","pages":""},"PeriodicalIF":10.8,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343136","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}
Robab Breyer-Kohansal, Daniela Tomasoni, Bernhard Haring
{"title":"The Dyspnea Clinic: a new emerging interdisciplinary medical concept.","authors":"Robab Breyer-Kohansal, Daniela Tomasoni, Bernhard Haring","doi":"10.1093/ejhf/xuaf005","DOIUrl":"https://doi.org/10.1093/ejhf/xuaf005","url":null,"abstract":"","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":" ","pages":""},"PeriodicalIF":10.8,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343155","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}
Pedro Marques, Francisco Vasques-Nóvoa, Faiez Zannad, Patrick Rossignol, João Pedro Ferreira
{"title":"Mineralocorticoid receptor antagonists reduce new-onset atrial fibrillation across the cardio-kidney-metabolic spectrum: a meta-analysis of randomized clinical trials.","authors":"Pedro Marques, Francisco Vasques-Nóvoa, Faiez Zannad, Patrick Rossignol, João Pedro Ferreira","doi":"10.1093/ejhf/xuaf009","DOIUrl":"https://doi.org/10.1093/ejhf/xuaf009","url":null,"abstract":"","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":" ","pages":""},"PeriodicalIF":10.8,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343119","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}
Tariq Jamal Siddiqi, Muhammad Shahzeb Khan, Gregg C Fonarow, Javed Butler, Stephen J Greene
{"title":"Reply to commentary on 'effect of glucagon-like peptide-1 receptor agonists on heart failure outcomes and cardiovascular death across varying cardiovascular kidney-metabolic comorbidity'.","authors":"Tariq Jamal Siddiqi, Muhammad Shahzeb Khan, Gregg C Fonarow, Javed Butler, Stephen J Greene","doi":"10.1093/ejhf/xuaf004","DOIUrl":"https://doi.org/10.1093/ejhf/xuaf004","url":null,"abstract":"","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":" ","pages":""},"PeriodicalIF":10.8,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343236","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}
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
Aims: 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.
Methods: 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.
Conclusions: 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.
目的:心力衰竭(HF)伴保留(HFpEF)和轻度降低(HFmrEF)射血分数是普遍存在的,但经常被误诊的综合征与高发病率和死亡率、生活质量受损和不断增加的医疗保健支出相关。尽管SGLT2抑制剂等指导药物已被证明可以降低住院和心血管死亡的风险,但它们的使用仍然有限,大量残留风险仍然存在。本试验旨在评估新型左心房-冠状窦分流器(Edwards APTURE经导管分流系统)在HFpEF和HFmrEF患者中的安全性和性能。方法:ALT-FLOW II是一项前瞻性多中心、随机、假对照、双盲(患者和评估者)试验。约100例年龄≥18岁、左心室射血分数bbb40 %、运动肺动脉毛细血管楔压(PCWP)≥25 mm Hg、PCWP与右心房压力梯度≥8 mm Hg的症状性HF患者将按1:1随机分为APTURE分流组与假对照组。关键的排除标准包括严重的心衰、明显的瓣膜疾病和轻度以上的右室功能不全。主要终点是APTURE设备在30天的安全性,以及6个月时工作负荷校正后的PCWP与体重标准化的变化。次要终点包括患者报告结果的变化,以及5年内血液动力学和超声心动图参数的变化。该试验还将利用多模态成像技术探讨该设备对短期心脏重构和心内血流模式的影响。结论:ALT-FLOW II试验将评估APTURE系统在伴有左房压升高的症状性HFpEF和HFmrEF患者中的安全性和性能。
{"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":"https://doi.org/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":""},"PeriodicalIF":10.8,"publicationDate":"2026-01-08","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}
Ashley Sharp, Tar-Choon Aw, Thu-Thao Le, Soon-Kieng Phua, A Mark Richards, Michael Böhm, Javier Díez, Javed Butler, Calvin W L Chin
Aims: To evaluate whether circulating N-terminal pro-B type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac troponin T (hsTnT) can stage hypertensive heart disease (HHD), by assessing their association with adverse cardiac remodelling and cardiovascular outcomes in individuals with essential hypertension.
Methods and results: The REMODEL study prospectively enrolled 1054 asymptomatic individuals with essential hypertension and no prior cardiovascular diseases (59 ± 11 years old; systolic blood pressure 131 ± 14 mmHg; left ventricular ejection fraction 60 ± 7%). All participants underwent cardiovascular magnetic resonance (CMR) and blood sampling for NT-proBNP and hsTnT. The primary outcome was a composite of acute coronary syndromes, heart failure hospitalization, stroke and all-cause mortality. Median follow-up was 53 (23, 72) months. Maximal log-rank statistic identified thresholds of 152 pg/ml for NT-proBNP and 12.7 pg/ml for hsTnT. Individuals with elevations in both biomarkers (high-risk) were older, had the highest 24-h systolic blood pressure and more diabetes mellitus. They showed the most adverse CMR phenotype, with increased myocardial mass, greater diffuse and replacement fibrosis, impaired left ventricular strain and higher left atrial volumes. Event rates differed significantly across biomarker strata (log-rank P < .001). High-risk individuals had the greatest hazard of cardiovascular events [hazard ratio (HR) 17.11; 95% confidence interval (CI) 8.12-36.09), while intermediate-risk individuals showed intermediate risk (HR 3.44; 95% CI 1.71-6.94).
Conclusion: NT-proBNP and hsTnT are complementary biomarkers that not only predict cardiovascular outcomes and but also reflect the severity of cardiac remodelling in HHD. Their combined use enables effective staging of disease severity and may support stage-specific management strategies in patients with hypertension.
目的:通过评估循环n端前b型利钠肽(NT-proBNP)和高敏感性心肌肌钙蛋白T (hsTnT)与原发性高血压患者不良心脏重构和心血管结局的关系,评估它们是否可以分期高血压性心脏病(HHD)。方法和结果:REMODEL研究前瞻性纳入1054例无症状的原发性高血压患者,既往无心血管疾病(59±11岁,收缩压131±14 mmHg,左室射血分数60±7%)。所有参与者都接受了心血管磁共振(CMR)和NT-proBNP和hsTnT的血液采样。主要结局是急性冠状动脉综合征、心力衰竭住院、中风和全因死亡率的综合结果。中位随访时间为53(23,72)个月。最大log-rank统计鉴定NT-proBNP的阈值为152 pg/ml, hsTnT的阈值为12.7 pg/ml。两种生物标志物(高危)均升高的个体年龄较大,24小时收缩压最高,糖尿病患者较多。他们表现出最不利的CMR表型,心肌质量增加,弥漫性和替代性纤维化加重,左心室应变受损,左心房容积增大。不同生物标志物层的事件发生率差异显著(log-rank P < 0.001)。高危人群发生心血管事件的风险最大[危险比(HR) 17.11;95%可信区间(CI) 8.12-36.09),而中危个体表现为中度风险(HR 3.44; 95% CI 1.71-6.94)。结论:NT-proBNP和hsTnT是互补的生物标志物,不仅可以预测心血管预后,还可以反映HHD患者心脏重构的严重程度。它们的联合使用可以有效地对疾病严重程度进行分期,并可能支持高血压患者的分期特异性管理策略。
{"title":"Role of natriuretic peptides and cardiac troponins in staging hypertensive heart disease: the REMODEL study.","authors":"Ashley Sharp, Tar-Choon Aw, Thu-Thao Le, Soon-Kieng Phua, A Mark Richards, Michael Böhm, Javier Díez, Javed Butler, Calvin W L Chin","doi":"10.1093/ejhf/xuaf001","DOIUrl":"https://doi.org/10.1093/ejhf/xuaf001","url":null,"abstract":"<p><strong>Aims: </strong>To evaluate whether circulating N-terminal pro-B type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac troponin T (hsTnT) can stage hypertensive heart disease (HHD), by assessing their association with adverse cardiac remodelling and cardiovascular outcomes in individuals with essential hypertension.</p><p><strong>Methods and results: </strong>The REMODEL study prospectively enrolled 1054 asymptomatic individuals with essential hypertension and no prior cardiovascular diseases (59 ± 11 years old; systolic blood pressure 131 ± 14 mmHg; left ventricular ejection fraction 60 ± 7%). All participants underwent cardiovascular magnetic resonance (CMR) and blood sampling for NT-proBNP and hsTnT. The primary outcome was a composite of acute coronary syndromes, heart failure hospitalization, stroke and all-cause mortality. Median follow-up was 53 (23, 72) months. Maximal log-rank statistic identified thresholds of 152 pg/ml for NT-proBNP and 12.7 pg/ml for hsTnT. Individuals with elevations in both biomarkers (high-risk) were older, had the highest 24-h systolic blood pressure and more diabetes mellitus. They showed the most adverse CMR phenotype, with increased myocardial mass, greater diffuse and replacement fibrosis, impaired left ventricular strain and higher left atrial volumes. Event rates differed significantly across biomarker strata (log-rank P < .001). High-risk individuals had the greatest hazard of cardiovascular events [hazard ratio (HR) 17.11; 95% confidence interval (CI) 8.12-36.09), while intermediate-risk individuals showed intermediate risk (HR 3.44; 95% CI 1.71-6.94).</p><p><strong>Conclusion: </strong>NT-proBNP and hsTnT are complementary biomarkers that not only predict cardiovascular outcomes and but also reflect the severity of cardiac remodelling in HHD. Their combined use enables effective staging of disease severity and may support stage-specific management strategies in patients with hypertension.</p>","PeriodicalId":164,"journal":{"name":"European Journal of Heart Failure","volume":" ","pages":""},"PeriodicalIF":10.8,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343259","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}