American heart journal最新文献

{"title":"Design of Screening Cardiometabolic Opportunities Using Transformative Echocardiography Artificial Intelligence (SCOUT-Echo-AI).","authors":"Sahir Eusuff, Jay Kim, Zara Fatima, Dilek Yalcinkaya, Yuki Sahashi, Alexander Sandhu, Long H Nguyen, Andrew P Ambrosy, Paul P Cheng, Stephanie T Chang, Alan S Go, Faraz S Ahmad, Amanda Cheung, Susan Cheng, Alan C Kwan, David Ouyang","doi":"10.1016/j.ahj.2026.107628","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107628","url":null,"abstract":"<p><strong>Background: </strong>Steatotic liver disease (SLD) is highly prevalent among individuals with cardiovascular disease, but often remains undiagnosed until advanced sequelae such as fibrotic liver disease and hepatocellular carcinoma develop. ​​Transthoracic echocardiography routinely captures incidental subcostal views of the liver that are not used clinically. The EchoNet-Liver algorithm uses artificial intelligence (AI) to predict the presence of liver disease based on routine clinical echocardiograms. Prospective evaluation in real-world practice is needed to understand the clinical utility and impact of AI-enabled opportunistic liver disease screening.</p><p><strong>Methods: </strong>The SCOUT-Echo-AI study is a single-arm, prospective, multicenter, open-label pragmatic interventional trial that will be conducted across six diverse U.S. healthcare systems (Kaiser Permanente Northern California, Stanford Healthcare, Cedars-Sinai Medical Center, University of California Los Angeles, Northwestern Medicine, and Massachusetts General Brigham). Routine echocardiograms will be analyzed by the EchoNet-Liver AI algorithm with an estimated enrollment of ∼3,000 patients. Treating clinicians or participants themselves will be notified of potential undiagnosed liver disease with site-specific workflows in place to ensure routine clinical care for definitive case confirmation. Primary outcomes will be SLD and fibrotic liver disease detection rates and positive predictive values within 12 months of AI identification. Pre-specified secondary outcomes will assess diagnostic accuracy against other gold-standard modalities, treatment initiation, time to diagnosis, and impact on other clinical events. Outcomes will be compared against historical usual-care and contemporary below-threshold cohorts.</p><p><strong>Conclusion: </strong>SCOUT-Echo-AI is a prospective multicenter study evaluating the real-world impact of AI-enabled opportunistic liver disease screening using routine echocardiography.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107628"},"PeriodicalIF":3.4,"publicationDate":"2026-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149223097","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A randomized controlled trial of a novel AI-based prognostic decision support tool integrated into the electronic health record for ischemic heart disease: Rationale and design of the PM Heart trial.","authors":"Anna Kirstine Ringgaard, Søren Albertsen Rand, Chaoqun Zheng, Maria Elizabeth Engel Møller, Alex Hørby Christensen, Anders Christian Riis-Jensen, Bettina Wimmer, Dan Eik Høfsten, Johan Skov Bundgaard, Franziska Valder, Iben Mundbjerg Gjødsbøl, Mette Gørtz, Mette Hartlev, Mette Nordahl Svendsen, Sisse Rye Ostrowski, Erik Sørensen, Ole B Pedersen, Jonas Ghouse, Ida Gustafsson, Matias Greve Lindholm, Suheil Andreas Salomon, Henrik Ryde, Hongmei Duan, Susette Krohn Therkelsen, Anne Merete Boas Soja, Mette Lykke Norgaard Bertelsen, Niels Tønder, Piotr Maria Walichiewicz, Stig Lyngbæk, Kirstine Lærum Sibilitz, Frants Pedersen, Lars Køber, Kasper Karmark Iversen, Daniel F Gudbjartsson, Hilma Holm, Søren Brunak, Peter Christoffer Holm, Amalie Dahl Haue, Henning Bundgaard","doi":"10.1016/j.ahj.2026.107631","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107631","url":null,"abstract":"<p><strong>Background: </strong>Ischemic heart disease (IHD) is the leading global cause of years of life lost. Although the clinical presentation and progression of IHD differ widely, clinical management is relatively uniform. To improve risk stratification and clinical management, we developed a decision support tool - the PMHeart^IHD Algorithm (also named PMHNet) - based on extensive clinical, registry and biochemical data. This algorithm automatically calculates one-year survival following an IHD event. We hypothesize that presenting the prognoses calculated by the PMHeart^IHD Algorithm to the treating physicians will improve both the clinical management and outcome of the individual patient.</p><p><strong>Objective: </strong>The objectives of the PM Heart trial include clinical and technical aspects. First, the primary aim is to investigate if the clinical use of the prognosis calculated by the algorithm improves patient prognosis and minimizes the risk of re-hospitalization, compared to standard of care. A secondary objective is to generate knowledge on how decision support tools in cardiology may be implemented, received, and used directly in clinical practice.</p><p><strong>Methods: </strong>The PMHeart^IHD Aalgorithm has been integrated into the electronic health record (EHR) system (Sundhedsplatformen (SP), EPIC) for clinical use. The PM Heart trial is designed as a multicenter, prospective, randomized, open-label, clinical trial, automatically enrolling and randomizing hospitalized patients with coronary artery disease at the cardiology departments in The Capital Region and Region Zealand in Denmark. Patients are randomized (1:1 ratio) immediately after coronary angiography, to either show or hide the calculated PMHeart^IHD-prognosis or not in the electronic health record.</p><p><strong>Results: </strong>The primary outcome is a composite outcome consisting of re-admissions within 30 days and one-year survival rates after randomization. Inclusion began September 2023, and follow-up is expected to finish in 2026.</p><p><strong>Conclusions: </strong>We present the design of and rationale for the PM Heart trial. Our aim is to assess the clinical value of implementing an artificial intelligence-based decision support tool in clinical practice.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107631"},"PeriodicalIF":3.4,"publicationDate":"2026-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149219900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mechanism of Mortality in Individuals with Elevated Risk Pulmonary Emboli: A Multicenter Analysis of a Contemporary Cohort.","authors":"Zach Rozenbaum, Eric Gnall, Ali Gholam, Mailing Flores Chang, Aabha Divya, Cristina Sanina, Jose Wiley","doi":"10.1016/j.ahj.2026.107629","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107629","url":null,"abstract":"<p><p>The underlying causes of mortality in patients with pulmonary embolism have been investigated in the past, yet management of pulmonary emboli has evolved and newer therapeutic options are available. Data from four hospitals during 2022-2025 were analyzed and all patients with intermediate-high risk and high risk pulmonary emboli who died during follow up were included. The results depicted in the research letter provide insight into the mechanism of morality in patients with pulmonary emboli by risk category and thereby help improve care and patient selection for interventions.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107629"},"PeriodicalIF":3.4,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149178906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A 0/2-Hour Algorithm Using a Novel Point-of-Care High-Sensitivity Cardiac Troponin I Assay for Suspected Myocardial Infarction.","authors":"Luca Koechlin, Pedro Lopez-Ayala, Jasper Boeddinghaus, Nina Sigg, Koray Durak, Thomas Nestelberger, Karin Wildi, Ivo Strebel, Paolo Bima, Luca Crisanti, Lourdes Herraiz Recuenco, Alperen Yueksel, Òscar Miró, F Javier Martin-Sanchez, Damian Kawecki, Dagmar I Keller, Michael Christ, Andreas Buser, Héctor Rodriguez Cetina Biefer, Omer Dzemali, Marianne Nordlund Broughton, Felix Mahfoud, Christian Mueller","doi":"10.1016/j.ahj.2026.107625","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107625","url":null,"abstract":"<p><p>This letter describes the derivation and internal validation of an assay-specific hs-cTnI-SPINCHIP 0/2h-algorithm for rapid triage of patients with suspected myocardial infarction (MI) in the emergency department (ED). The algorithm provided very high safety for rule-out, high accuracy for rule-in, and enabled definitive triage within 2 hours in approximately 80% of patients. These findings support the clinical potential of the novel point-of-care hs-cTnI-SPINCHIP assay for accelerated ED decision-making.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107625"},"PeriodicalIF":3.4,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149178902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pulsed field ablation with Renal denervation for persistent Atrial fibrIllation: Rationale and design of the PRAISE-AF randomized trial.","authors":"Jiongchao Guo, Mu Qin, Weifeng Jiang, Qingqi Ji, Yutong Miao, Zhenchi Sang, Ruogu Li, Xumin Hou, Wenzheng Han","doi":"10.1016/j.ahj.2026.107630","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107630","url":null,"abstract":"<p><strong>Background: </strong>Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia worldwide and is associated with increased risks of stroke, heart failure, hospitalization, disability, and mortality. Catheter ablation has become an established rhythm-control strategy for symptomatic AF; however, the recurrence rate after ablation remains substantial, especially in patients with persistent AF. Pulsed field ablation (PFA) is an emerging nonthermal ablation technology with myocardial tissue selectivity and a potentially improved safety profile compared with conventional thermal ablation. Renal denervation (RDN) reduces sympathetic nervous system activity and has shown promising effects in reducing AF recurrence when combined with catheter ablation, mainly in patients with paroxysmal AF and hypertension. Whether RDN combined with PFA improves rhythm outcomes in patients with persistent AF remains unknown.</p><p><strong>Trial design: </strong>This is a single center, prospective, randomized, patient-blinded, sham-controlled pilot exploratory trial. A total of 86 patients with symptomatic persistent AF undergoing first-time catheter ablation will be enrolled and randomly assigned in a 1:1 ratio to receive either PFA combined with RDN or PFA combined with a sham RDN procedure. Antiarrhythmic drugs (AADs) will be discontinued after the index procedure in both groups. The primary endpoint is freedom from documented atrial tachyarrhythmia recurrence, including AF, atrial flutter, or atrial tachycardia lasting more than 30 seconds, within 12 months after a single ablation procedure without AADs. Secondary endpoints include freedom from atrial tachycardia recurrence within 3 months, AF burden, blood pressure changes, and major adverse cardiovascular events. Safety endpoints include cardiac, vascular, renal, and other procedure-related adverse events.</p><p><strong>Conclusions: </strong>This trial will assess the safety and efficacy of PFA with RDN in a postablation contemporary persistent AF patient population.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov:NCT07320768.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107630"},"PeriodicalIF":3.4,"publicationDate":"2026-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149164801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design and Rationale of the CLASP II TR Randomized Trial for Severe Tricuspid Regurgitation.","authors":"Gorav Ailawadi, Charles J Davidson, Allen S Anderson, Rebecca T Hahn, Peyton Willert, Suzanne Y Gilmore, Chandan Vinekar, Bonnie Zhang, Maitreyi Muralidhar, Rachel Castro, Luoxi Shi, Angela Graham, Ted Feldman, Michael J Mack, Martin B Leon","doi":"10.1016/j.ahj.2026.107627","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107627","url":null,"abstract":"<p><p>Severe tricuspid regurgitation (TR) is a progressive disease associated with mortality, heart failure hospitalization (HFH), impaired functional status, and reduced quality of life. Transcatheter tricuspid valve repair and replacement therapies have expanded treatment options for TR patients beyond medical therapy and surgery and improved their functional status and symptoms. The CLASP II TR trial is a prospective, multicenter, open-label randomized trial designed to test superiority of tricuspid transcatheter edge-to-edge repair (T-TEER) with the PASCAL transcatheter valve repair system+optimal medical therapy (device group) versus optimal medical therapy alone (control group) in symptomatic severe TR patients. A total of 450 patients with ≥severe TR as assessed by an independent echocardiographic core laboratory are randomized following central screening committee assessment in a 2:1 ratio (device:control). The primary endpoint is a 6-month hierarchical composite combining key safety and efficacy outcomes (all-cause mortality, durable right ventricular assist device or heart transplant, elective or non-elective tricuspid valve surgery/intervention and number of HFH) with quality-of-life improvement assessed using Kansas City Cardiomyopathy Questionnaire Overall Summary score. Additionally, clinical, echocardiographic, functional, and quality-of-life parameters are also evaluated. Patients are assessed at baseline; 30 days; 3, 6, and 12 months; and annually through 5 years. Crossover of control patients is permitted either after the 2-year visit or when the last randomized patient completes 12-month follow-up. The CLASP II TR trial will inform the safety and effectiveness of the PASCAL system compared to medical therapy alone in the treatment of patients with symptomatic, severe tricuspid regurgitation. The trial has completed enrollment, and the report of primary results is expected. Trial Registration: Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP II TR); NCT04097145; https://clinicaltrials.gov/study/NCT04097145.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107627"},"PeriodicalIF":3.4,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149147143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design and rationale of the Urine Sodium-directed Diuretic Adjustment Strategy in Heart Failure (US-DASH) trial.","authors":"Andrew Lurie, Padideh Daneii, Chia-Hung Sze, Aqeel Khanani, Jennifer Trube, Walter Wills, Andrew Bugajski, Lauren Morata, Nancy Finnigan, Joel Fernandez, Anas Bizanti","doi":"10.1016/j.ahj.2026.107622","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107622","url":null,"abstract":"<p><strong>Rationale: </strong>Recent studies have shown natriuresis-guided diuretic adjustment strategies result in greater natriuresis and diuresis than the standard of practice in acute heart failure. There is no consensus for which natriuretic goal optimally balances decongestion with adverse clinical outcomes.</p><p><strong>Primary hypothesis: </strong>This study will test the hypothesis that (i.) a high-threshold natriuresis target improves natriuresis compared with both a low-threshold natriuretic strategy and traditional methods, and (ii.) natriuresis in absence of urine output monitoring can safely guide management. The primary endpoint is 24-hour natriuresis.</p><p><strong>Design: </strong>Pragmatic, single-center, randomized, controlled, open-label with stratification by eGFR (greater than versus less than 60 mL/min/1.73 m²) and number of home diuretics (0-1 versus 2+).</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107622"},"PeriodicalIF":3.4,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149102917","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sex-based differences in mortality and prognostic factors for infective endocarditis: insights from a retrospective cohort of 519 patients.","authors":"Marie Vincent, Claire Samant, Robinson Gravier-Dumonceau, Selene Rost, Frédérique Gouriet, Laetitia Tessonnier, Alberto Riberi, Titouan Runet-Arnoux, Sandrine Hubert, Claire Lucas, Frédéric Collart, Laurence Camoin-Jau, Gilbert Habib, Mary Philip","doi":"10.1016/j.ahj.2026.107621","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107621","url":null,"abstract":"<p><strong>Introduction: </strong>Infective endocarditis (IE) remains a severe disease with high mortality despite advances in management. Although it predominantly affects male patients, female patients account for about one-quarter of cases. Sex-specific differences in outcomes and prognostic factors remain insufficiently explored.</p><p><strong>Methods: </strong>We conducted a retrospective study including 519 patients ≥16 years hospitalized for definite or possible IE (ESC 2023 criteria) at La Timone Hospital, Marseille, between March 2019 and October 2023. The primary endpoint was one-year mortality; secondary endpoints included surgical management, valve involvement, and prognostic factors.</p><p><strong>Results: </strong>Of the 519 patients, 26% were female patients. One-year mortality was comparable between sexes (27% in female patients vs. 23% in male patients, p = 0.415). Post-discharge mortality was not significantly different between sexes (p = 0.096). Mitral valve involvement was more frequent in female patients, and aortic involvement predominated in male patients. Independent predictors of mortality included annular complications and lack of surgery. Importantly, sex-specific differences in prognostic factors were observed in this exploratory analysis: in female patients, TAVI and ischemic heart disease were associated with higher mortality; in male patients, right-sided IE and pacemaker presence were predictive. Furthermore, fatal cases in male patients were marked by more in-hospital complications (heart failure, cardiogenic or septic shock, acute renal failure), suggesting distinct mortality pathways.</p><p><strong>Conclusion: </strong>Although overall mortality was similar between sexes, male patients and female patients with IE appeared to show different prognostic profiles in this single-center cohort. These preliminary, hypothesis-generating findings suggest that some established risk factors may largely reflect male data, emphasizing the need for larger, multicenter studies to confirm sex-specific determinants and improve individualized management.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107621"},"PeriodicalIF":3.4,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149103086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design and rationale of the TANGO2 trial: A randomized controlled non-inferiority trial of bystander compression-only CPR versus standard CPR in out-of-hospital cardiac arrest.","authors":"Erik Boberg, Giulia Merigo, Gabriel Riva, Mattias Ringh, Giuseppe Ristagno, Martin Jonsson, Cecilia Nordius, Aurora Magliocca, Markus B Skrifvars, Fredrik Byrsell, Fredrik Jonsson, Andreas Claesson, Leif Svensson, Per Nordberg, Annette Nord, Jacob Hollenberg","doi":"10.1016/j.ahj.2026.107623","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107623","url":null,"abstract":"<p><strong>Rationale: </strong>Bystander cardiopulmonary resuscitation (CPR) before emergency medical services arrival is associated with improved survival after out-of-hospital cardiac arrest (OHCA). Compression-only CPR (CO-CPR) is simpler to teach and perform, eliminates interruptions in chest compressions for rescue breaths, and has been associated with higher bystander CPR rates. For adults with OHCA of presumed medical etiology, clinical equipoise remains regarding the optimal CPR strategy for previously trained bystanders.</p><p><strong>Primary hypothesis: </strong>Bystander CO-CPR is non-inferior to standard CPR (S-CPR) for 30-day survival in dispatch-assisted out-of-hospital cardiac arrest DESIGN: TANGO2 is an international, multicenter, randomized, open-label, non-inferior trial. Dispatchers randomize eligible cases 1:1 to CO-CPR or S-CPR via an integrated decision-support system. Protocol adherence is evaluated via systematic dispatch audio review. Per-protocol (PP) analysis is prespecified as the primary analysis, supported by modified intention-to-treat (mITT) analysis. Non-inferiority is defined as an absolute risk difference above -1.0 percentage points.</p><p><strong>Sites: </strong>All Emergency Medical Dispatch Centers in Sweden and selected sites in Italy.</p><p><strong>Estimated enrollment: </strong>3,260 per-protocol EMS-treated OHCA patients ENROLLMENT DATES: Start date: 2017. Estimated completion date: December 2027.</p><p><strong>Current status: </strong>Enrolling.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT03981107, https://clinicaltrials.gov/study/NCT03981107.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107623"},"PeriodicalIF":3.4,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149103010","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design and baseline characteristics of the CagriSema cardiovascular outcomes trial (REDEFINE 3).","authors":"Matthew A Cavender, Ania M Jastreboff, Alice Y Y Cheng, Melanie J Davies, Lucienne Donaldson, Lars-Ole Gerlach, Silas Hinsch Gylvin, Jacob Bonde Jacobsen, Nikolaus Marx, Cynthia Karenina Osorto Contreras, Carel W Le Roux, A Michael Lincoff","doi":"10.1016/j.ahj.2026.107626","DOIUrl":"https://doi.org/10.1016/j.ahj.2026.107626","url":null,"abstract":"<p><strong>Importance: </strong>Cagrilintide-semaglutide (CagriSema) is a fixed-dose combination of the amylin receptor agonist cagrilintide and the glucagon-like peptide-1 receptor agonist semaglutide administered subcutaneously once weekly. CagriSema has demonstrated significant weight reduction and improved glycemic control in participants with excess adiposity and type 2 diabetes (T2D).</p><p><strong>Methods: </strong>REDEFINE 3 is a double-blind, randomized, placebo-controlled trial involving participants with established cardiovascular disease (CVD) and body mass index (BMI) ≥25.0 kg/m² with/without T2D randomized to CagriSema 2.4 mg/2.4 mg or placebo, plus standard of care. The safety objective is to confirm noninferiority of CagriSema compared with placebo on cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke (MACE-3). The efficacy objective is to confirm the superiority of CagriSema compared with placebo on cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or revascularization (MACE-4).</p><p><strong>Results: </strong>Between 1/2023-12/2024, 7076 adults at 575 sites in 24 countries were randomized. Mean age at baseline was 66 years. BMI ≥30 kg/m² was present in 76% of participants (n=5370). In participants with T2D (n=4348, 61%), the mean duration of T2D was 12 years and mean glycated hemoglobin was 7.7%. Most participants had a prior myocardial infarction (n=4369, 62%). Prior stroke (n=1311, 19%) and peripheral arterial disease (n=769, 11%) were less common, and 617 participants (9%) had more than one qualifying CVD criteria.</p><p><strong>Conclusion: </strong>The REDEFINE 3 trial will provide evidence regarding the cardiovascular safety and efficacy of CagriSema, a novel fixed-dose combination therapy that could improve cardiovascular outcomes in a broad population of people with established CVD and excess adiposity.</p><p><strong>Trial registration: </strong>The REDEFINE 3 trial is registered at ClinicalTrials.gov (NCT05669755).</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"107626"},"PeriodicalIF":3.4,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149102845","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}