Pub Date : 2025-12-18DOI: 10.1016/j.ahj.2025.107312
Sheldon E Litwin , Jan Komtebedde , Barry A Borlaug , David M Kaye , Gerd Hasenfuβ , Rami Kahwash , Elke Hoendermis , Scott L Hummel , Maja Cikes , Finn Gustafsson , Eugene S Chung , Rajeev C Mohan , Aaron L Sverdlov , Vijendra Swarup , Sebastian Winkler , Christopher S Hayward , Martin W Bergmann , Heiko Bugger , Scott McKenzie , Ajith Nair , Sanjiv J Shah
{"title":"Corrigendum to “Long-term safety and outcomes after atrial shunting for heart failure with preserved or mildly reduced ejection fraction: 5-year and 3-year follow-up in the REDUCE LAP-HF I and II trials” [American Heart Journal (278)2024 Page Number:106-116]","authors":"Sheldon E Litwin , Jan Komtebedde , Barry A Borlaug , David M Kaye , Gerd Hasenfuβ , Rami Kahwash , Elke Hoendermis , Scott L Hummel , Maja Cikes , Finn Gustafsson , Eugene S Chung , Rajeev C Mohan , Aaron L Sverdlov , Vijendra Swarup , Sebastian Winkler , Christopher S Hayward , Martin W Bergmann , Heiko Bugger , Scott McKenzie , Ajith Nair , Sanjiv J Shah","doi":"10.1016/j.ahj.2025.107312","DOIUrl":"10.1016/j.ahj.2025.107312","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"293 ","pages":"Article 107312"},"PeriodicalIF":3.5,"publicationDate":"2025-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145787181","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}
Pub Date : 2025-12-18DOI: 10.1016/j.ahj.2025.107326
Israel Júnior Borges do Nascimento MD, MSc , Renato D. Lopes MD, PhD , Marcos Venicius Malveira De Lima , Matheus de Freitas Itaborahy , Alexander C. Fanaroff MD, PhD , Brijesh Sathian MD, PhD , Holger Thiele MD, PhD , Bruno Ramos Nascimento
<div><h3>Background</h3><div>ST-Segment Elevation Myocardial Infarction (STEMI) is considered the main cause of mortality and morbidity for decades globally. Regularly, cardiology-related medical organizations publish clinical practice guidelines (CPGs) to support healthcare professionals in the diagnosis, management, and prevention of future cardiovascular events. Nevertheless, the level of evidence (LOE) and classification of recommendations (CORs) endorsing STEMI-associated CPGs recommendations have not been systematically appraised.</div></div><div><h3>Purpose</h3><div>This meta-research study evaluated and described the CORs and LOE over time for STEMI guidelines endorsed by the American Heart Association (AHA), American College of Cardiology (ACC), and European Society of Cardiology (ESC), from 1990 to 2023.</div></div><div><h3>Data sources</h3><div>We initially searched on PubMed and AHA/ACC/ESC electronic repositories to obtain STEMI-related CPGs, published from 1990 to 2023, including their immediate predecessors.</div></div><div><h3>Study Selection</h3><div>Guidelines related to acute in-hospital STEMI management were included; recommendations related to unstable angina/Non–STEMI were excluded.</div></div><div><h3>Data Extraction</h3><div>Data management was performed by 2 content experts. Recommendations on pharmacological and nonpharmacological interventions (PI and NPI, respectively) were extracted ipsilaterally, further processed and coded based on thematic analysis fundamentals. Recommendation's recordings associated with each recommendation were maintained as the primary guideline publication without team's specialist judgement. Pharmacological-related recommendations were categorized in accordance with the Anatomical Therapeutic Chemical Classification System by the WHO Collaborating Centre for Drug Statistics Methodology. Changes in the proportion and LOE were evaluated longitudinally, using chi-square test (x<sup>2</sup>). Data visualization included heatmaps, linear plots, and Sankey diagrams.</div></div><div><h3>Data Synthesis</h3><div>Twenty-six guidelines (2,139 STEMI-specific recommendations) were evaluated. We observed an overall predominance of recommendations relying on moderate (proportion of 30.1% of LOE-B recommendations) or low (proportion of 28.9% of LOE-C recommendations) quality of evidence over the 33-year span. Only 17.7% of processed recommendations were based on high quality of evidence. Pharmacological interventions were more often LOE-A compared with NPI (21.5% vs 13.8%; <em>P</em>-value < 0.05). Most abstracted PI related to anticoagulants and dual anti-platelet therapies, while the most frequent category of NPI were related to percutaneous coronary interventions and implantable cardiac devices. Two consecutive guidelines comparison revealed that LOE and COR assigned to corresponding recommendation were minimal.</div></div><div><h3>Limitations</h3><div>Restriction to only AHA/ACC/ESC guidelines and prim
{"title":"Coevolutionary analysis of evidence and recommendations in STEMI clinical practice guidelines: A 33-year meta-research study of ACC, AHA, and ESC","authors":"Israel Júnior Borges do Nascimento MD, MSc , Renato D. Lopes MD, PhD , Marcos Venicius Malveira De Lima , Matheus de Freitas Itaborahy , Alexander C. Fanaroff MD, PhD , Brijesh Sathian MD, PhD , Holger Thiele MD, PhD , Bruno Ramos Nascimento","doi":"10.1016/j.ahj.2025.107326","DOIUrl":"10.1016/j.ahj.2025.107326","url":null,"abstract":"<div><h3>Background</h3><div>ST-Segment Elevation Myocardial Infarction (STEMI) is considered the main cause of mortality and morbidity for decades globally. Regularly, cardiology-related medical organizations publish clinical practice guidelines (CPGs) to support healthcare professionals in the diagnosis, management, and prevention of future cardiovascular events. Nevertheless, the level of evidence (LOE) and classification of recommendations (CORs) endorsing STEMI-associated CPGs recommendations have not been systematically appraised.</div></div><div><h3>Purpose</h3><div>This meta-research study evaluated and described the CORs and LOE over time for STEMI guidelines endorsed by the American Heart Association (AHA), American College of Cardiology (ACC), and European Society of Cardiology (ESC), from 1990 to 2023.</div></div><div><h3>Data sources</h3><div>We initially searched on PubMed and AHA/ACC/ESC electronic repositories to obtain STEMI-related CPGs, published from 1990 to 2023, including their immediate predecessors.</div></div><div><h3>Study Selection</h3><div>Guidelines related to acute in-hospital STEMI management were included; recommendations related to unstable angina/Non–STEMI were excluded.</div></div><div><h3>Data Extraction</h3><div>Data management was performed by 2 content experts. Recommendations on pharmacological and nonpharmacological interventions (PI and NPI, respectively) were extracted ipsilaterally, further processed and coded based on thematic analysis fundamentals. Recommendation's recordings associated with each recommendation were maintained as the primary guideline publication without team's specialist judgement. Pharmacological-related recommendations were categorized in accordance with the Anatomical Therapeutic Chemical Classification System by the WHO Collaborating Centre for Drug Statistics Methodology. Changes in the proportion and LOE were evaluated longitudinally, using chi-square test (x<sup>2</sup>). Data visualization included heatmaps, linear plots, and Sankey diagrams.</div></div><div><h3>Data Synthesis</h3><div>Twenty-six guidelines (2,139 STEMI-specific recommendations) were evaluated. We observed an overall predominance of recommendations relying on moderate (proportion of 30.1% of LOE-B recommendations) or low (proportion of 28.9% of LOE-C recommendations) quality of evidence over the 33-year span. Only 17.7% of processed recommendations were based on high quality of evidence. Pharmacological interventions were more often LOE-A compared with NPI (21.5% vs 13.8%; <em>P</em>-value < 0.05). Most abstracted PI related to anticoagulants and dual anti-platelet therapies, while the most frequent category of NPI were related to percutaneous coronary interventions and implantable cardiac devices. Two consecutive guidelines comparison revealed that LOE and COR assigned to corresponding recommendation were minimal.</div></div><div><h3>Limitations</h3><div>Restriction to only AHA/ACC/ESC guidelines and prim","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107326"},"PeriodicalIF":3.5,"publicationDate":"2025-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145800414","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}
Pub Date : 2025-12-17DOI: 10.1016/j.ahj.2025.107329
Katherine T. Mills PhD , Trevor Ferguson DM, PhD , Jose P. Lopez-Lopez MD , Jacqueline Duncan MD, MPH , Paola Lanza MD , Allison Marshall PhD , Mabel Reyes , Jing Chen MD , Amanda H. Anderson PhD , Paul K. Whelton MD, MSc , Althea Bailey PhD , Carene Lindsay MSc , Gregorio Sanchez MD , Patricio Lopez-Jaramillo MD, PhD , Marshall Tulloch-Reid MD, DSc , Jiang He MD, PhD
Rationale
Hypertension disproportionately affects populations in low- and middle-income countries (LMICs), especially in Latin America and the Caribbean, due to its high prevalence and low control rate.
Primary Hypothesis
To close the knowledge-practice gap for blood pressure (BP) control, we are assessing the effectiveness and implementation of a team-based care strategy for BP control in primary care clinics in Colombia and Jamaica.
Design
The Caribbean and South American Team-based Strategy to Control Hypertension (CATCH) study is a cluster randomized trial using an effectiveness–implementation hybrid type-2 design. Clinics were randomly assigned to a team-based strategy or a provider-training strategy to implement current hypertension guidelines. The team-based strategy includes healthcare team training, care coordination, task sharing, BP audit and feedback, home BP monitoring, health coaching, single-pill combination therapy, and increased medication access. The primary clinical effectiveness outcome is difference in mean change of systolic BP from baseline to 18 months between randomized groups. The primary implementation outcome is a composite fidelity score to key implementation strategy components.
Sites
CATCH is conducted in 40 primary care clinics in Jamaica and Colombia.
Enrollment
Between February 2023 and August 2024, we recruited 1,707 participants, exceeding our planned enrollment. The planned sample size of 1,680 (42 patients per each of 40 clinics) has 90% statistical power to detect a 6.0 mm Hg difference in mean systolic BP change assuming 85% follow-up and a 2-sided significance level of 0.05.
Current Status
In follow-up
Conclusions
CATCH will provide evidence on effectiveness and implementation of a team-based care strategy to improve hypertension control in real-world, primary care settings. If proven effective, this approach can be scaled up in primary care throughout low- and middle-income countries (LMICs).
Clinical Trial Registration
Clinicaltrials.gov, NCT05405920
https://clinicaltrials.gov/study/ NCT05405920.
理由：由于高血压的高患病率和低控制率，它对低收入和中等收入国家（LMICs）人群的影响格外严重，尤其是在拉丁美洲和加勒比地区。主要假设：为了缩小血压控制的知识与实践差距，我们正在评估哥伦比亚和牙买加初级保健诊所中以团队为基础的血压控制护理策略的有效性和实施情况。设计：加勒比和南美以团队为基础的高血压控制策略（CATCH）研究是一项采用有效性-实施混合型2型设计的聚类随机试验。诊所被随机分配到以团队为基础的策略或提供者培训策略，以实施当前的高血压指南。基于团队的策略包括医疗团队培训、护理协调、任务共享、血压审计和反馈、家庭血压监测、健康指导、单片联合治疗和增加药物获取。主要临床疗效指标是随机分组之间从基线到18个月的平均收缩压变化的差异。主要的实现结果是对关键实现策略组件的复合保真度评分。地点：CATCH在牙买加和哥伦比亚的40个初级保健诊所开展。招募：在2023年2月至2024年8月期间，我们招募了1707名参与者，超过了我们的计划招募人数。计划样本量为1680例（40家诊所每家42例患者），假设随访率为85%，双侧显著性水平为0.05，有90%的统计能力检测到平均收缩压变化6.0 mm Hg的差异。结论：CATCH将提供基于团队的护理策略的有效性和实施的证据，以改善现实世界初级保健环境中的高血压控制。如果证明有效，这种方法可以在整个中低收入国家的初级保健中推广。试验注册：Clinicaltrials.gov, NCT05405920 https://clinicaltrials.gov/study/NCT05405920。
{"title":"Caribbean and South American team-based strategy to control hypertension (CATCH): Rationale and study design of a cluster randomized trial","authors":"Katherine T. Mills PhD , Trevor Ferguson DM, PhD , Jose P. Lopez-Lopez MD , Jacqueline Duncan MD, MPH , Paola Lanza MD , Allison Marshall PhD , Mabel Reyes , Jing Chen MD , Amanda H. Anderson PhD , Paul K. Whelton MD, MSc , Althea Bailey PhD , Carene Lindsay MSc , Gregorio Sanchez MD , Patricio Lopez-Jaramillo MD, PhD , Marshall Tulloch-Reid MD, DSc , Jiang He MD, PhD","doi":"10.1016/j.ahj.2025.107329","DOIUrl":"10.1016/j.ahj.2025.107329","url":null,"abstract":"<div><h3>Rationale</h3><div>Hypertension disproportionately affects populations in low- and middle-income countries (LMICs), especially in Latin America and the Caribbean, due to its high prevalence and low control rate.</div></div><div><h3>Primary Hypothesis</h3><div>To close the knowledge-practice gap for blood pressure (BP) control, we are assessing the effectiveness and implementation of a team-based care strategy for BP control in primary care clinics in Colombia and Jamaica.</div></div><div><h3>Design</h3><div>The Caribbean and South American Team-based Strategy to Control Hypertension (CATCH) study is a cluster randomized trial using an effectiveness–implementation hybrid type-2 design. Clinics were randomly assigned to a team-based strategy or a provider-training strategy to implement current hypertension guidelines. The team-based strategy includes healthcare team training, care coordination, task sharing, BP audit and feedback, home BP monitoring, health coaching, single-pill combination therapy, and increased medication access. The primary clinical effectiveness outcome is difference in mean change of systolic BP from baseline to 18 months between randomized groups. The primary implementation outcome is a composite fidelity score to key implementation strategy components.</div></div><div><h3>Sites</h3><div>CATCH is conducted in 40 primary care clinics in Jamaica and Colombia.</div></div><div><h3>Enrollment</h3><div>Between February 2023 and August 2024, we recruited 1,707 participants, exceeding our planned enrollment. The planned sample size of 1,680 (42 patients per each of 40 clinics) has 90% statistical power to detect a 6.0 mm Hg difference in mean systolic BP change assuming 85% follow-up and a 2-sided significance level of 0.05.</div></div><div><h3>Current Status</h3><div>In follow-up</div></div><div><h3>Conclusions</h3><div>CATCH will provide evidence on effectiveness and implementation of a team-based care strategy to improve hypertension control in real-world, primary care settings. If proven effective, this approach can be scaled up in primary care throughout low- and middle-income countries (LMICs).</div></div><div><h3>Clinical Trial Registration</h3><div><span><span>Clinicaltrials.gov</span><svg><path></path></svg></span>, NCT05405920</div><div><span><span>https://clinicaltrials.gov/study/</span><svg><path></path></svg></span> NCT05405920.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107329"},"PeriodicalIF":3.5,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145793031","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}
Pub Date : 2025-12-15DOI: 10.1016/j.ahj.2025.107327
Sarah D. de Ferranti MD MPH , Jessica E. Teng MPH , Silva A. Arslanian MD , Andrew M. Atz MD , Julie A. Brothers MD , Mark J. Cartoski MD , D’Andrea R. Freemon RN, MSN , Sheela N. Magge MD MSCE , William T. Mahle MD , Michele Mietus-Snyder MD , Amy Peterson MD MS , Geetha Raghuveer MD MPH , Mark W. Russell MD , Amy S. Shah , Craig A. Sponseller MD , Mario Stylianou PhD , Felicia L. Trachtenberg PhD , Elaine M. Urbina MD MS , Adam L. Ware MD , Justin Zachariah MD MPH , Brian W. McCrindle MD MPH
Background
Combined dyslipidemia of obesity (CDO) is a prevalent atherogenic lipid disorder characterized by high TG, low HDL, high non-HDL, and a preponderance of small LDL particles. Lifestyle modification is the mainstay of treatment but is often insufficient; a pharmacologic approach could augment care but has not been rigorously evaluated.
Methods
The dyslipidemia of obesity intervention in teens (DO IT!) Trial was a 2-year randomized controlled double-blind study designed to measure the effect and safety profile of pitavastatin calcium vs placebo on vascular measures of early atherosclerosis, and standard and advanced lipid profiles in children and adolescents with CDO. We present the rationale, design, and study procedures, and share challenges, responses, and lessons learned.
Results
Participants were recruited from 17 sites; goal 177, with 122 consented (68.9%). Facilitators to recruitment included familiarity of site investigators with CDO management, relationship with local obesity programs, and study incentives. Barriers included 2-year study duration, number of study visits, and COVID-19 pandemic effects. The research team added recruitment sites, expanded eligibility, shared educational and promotional materials, and bolstered site engagement but enrollment was insufficient, and the trial was stopped early.
Conclusions
The DO IT! Trial was the first to evaluate effects of pitavastatin vs placebo on vascular measures, lipid outcomes and potential adverse effects. Recruitment challenges limited the study sample, but findings may still inform cardiovascular prevention. Future studies are more likely to be more successful with early patient-family input, shorter study duration, and fewer study visits integrated with clinical care close to home.
{"title":"A multicenter trial to test pitavastatin calcium in youth with combined dyslipidemia of obesity: Design, implementation, challenges, and responses","authors":"Sarah D. de Ferranti MD MPH , Jessica E. Teng MPH , Silva A. Arslanian MD , Andrew M. Atz MD , Julie A. Brothers MD , Mark J. Cartoski MD , D’Andrea R. Freemon RN, MSN , Sheela N. Magge MD MSCE , William T. Mahle MD , Michele Mietus-Snyder MD , Amy Peterson MD MS , Geetha Raghuveer MD MPH , Mark W. Russell MD , Amy S. Shah , Craig A. Sponseller MD , Mario Stylianou PhD , Felicia L. Trachtenberg PhD , Elaine M. Urbina MD MS , Adam L. Ware MD , Justin Zachariah MD MPH , Brian W. McCrindle MD MPH","doi":"10.1016/j.ahj.2025.107327","DOIUrl":"10.1016/j.ahj.2025.107327","url":null,"abstract":"<div><h3>Background</h3><div>Combined dyslipidemia of obesity (CDO) is a prevalent atherogenic lipid disorder characterized by high TG, low HDL, high non-HDL, and a preponderance of small LDL particles. Lifestyle modification is the mainstay of treatment but is often insufficient; a pharmacologic approach could augment care but has not been rigorously evaluated.</div></div><div><h3>Methods</h3><div>The dyslipidemia of obesity intervention in teens (DO IT!) Trial was a 2-year randomized controlled double-blind study designed to measure the effect and safety profile of pitavastatin calcium vs placebo on vascular measures of early atherosclerosis, and standard and advanced lipid profiles in children and adolescents with CDO. We present the rationale, design, and study procedures, and share challenges, responses, and lessons learned.</div></div><div><h3>Results</h3><div>Participants were recruited from 17 sites; goal 177, with 122 consented (68.9%). Facilitators to recruitment included familiarity of site investigators with CDO management, relationship with local obesity programs, and study incentives. Barriers included 2-year study duration, number of study visits, and COVID-19 pandemic effects. The research team added recruitment sites, expanded eligibility, shared educational and promotional materials, and bolstered site engagement but enrollment was insufficient, and the trial was stopped early.</div></div><div><h3>Conclusions</h3><div>The DO IT! Trial was the first to evaluate effects of pitavastatin vs placebo on vascular measures, lipid outcomes and potential adverse effects. Recruitment challenges limited the study sample, but findings may still inform cardiovascular prevention. Future studies are more likely to be more successful with early patient-family input, shorter study duration, and fewer study visits integrated with clinical care close to home.</div><div>ClinicalTrials.gov identifier: NCT02956590.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107327"},"PeriodicalIF":3.5,"publicationDate":"2025-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145772937","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}
Pub Date : 2025-12-13DOI: 10.1016/j.ahj.2025.107328
Roberto Bolli MD, DSc , Xian-Liang Tang MD , Joshua M. Hare MD , Raul D. Mitrani MD , Emerson C. Perin MD, PhD , João AC Lima MD , Barry E. Hurwitz PhD , Dinesh Kalra MD , Gurnoor Singh MD , Russell G. Saltzman MPH , Lina V. Caceres MHS , Adriana Nettina MS , Yee-Shuan Lee PhD , Ketty Bacallao PhD , Edward Grant MPH , Aisha Khan PhD
Rationale
To date, almost all studies of cell therapy in chronic heart failure (HF) have delivered cells transendocardially or intracoronarily and all have used a single cell dose, which limits therapeutic efficacy because transplanted cells disappear rapidly. Repeated administrations are necessary to replace the cells that disappear, but this is difficult or impossible when cells are delivered invasively. Further, transendocardial delivery is not feasible in many patients, carries risks, and requires specialized training and equipment, thereby limiting its widespread applicability. Intravenous infusion of cells is cheaper, simpler, safer, and less invasive; most importantly, it enables administration of multiple cell doses.
Primary goal
The CATO trial tests a new strategy–repeated intravenous infusions of cells in chronic HF. The goal is to determine whether intravenous cell therapy is beneficial and whether multiple cell doses are superior to a single dose. This trial is the culmination of a translational journey that began more than a decade ago in animal models of HF.
Design
CATO is a Phase IIA randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy of intravenous infusion of umbilical cord-derived mesenchymal stromal cells (UC-MSCs) in patients with ischemic HF. Sixty subjects will be randomized to 3 groups: control (placebo), 1 dose of UC-MSCs, or 4 repeated doses of UC-MSCs, with a comprehensive evaluation of cardiac function and structure, functional capacity, quality of life, and biomarkers over 12 months.
Enrollment dates and current status
CATO began enrollment on March 4, 2024. As of November 30, 2025, a total of 47 patients have been enrolled. Enrollment is expected to be completed by March 2026, and follow-up by March 2027.
Significance
CATO is the first trial of UC-MSCs for HF in the US, the first study of intravenous cell therapy for ischemic HF in the US, and the first randomized, double-blind, placebo-controlled trial of repeated cell doses for chronic HF. The 2 strategies tested in CATO (intravenous cell delivery and repeated doses) have the potential to be important advances in the management of HF
{"title":"Design and rationale of CATO, a Phase IIA, randomized, double-blind, placebo-controlled study of single or repeated intravenous administration of umbilical cord-derived mesenchymal stromal cells in ischemic cardiomyopathy","authors":"Roberto Bolli MD, DSc , Xian-Liang Tang MD , Joshua M. Hare MD , Raul D. Mitrani MD , Emerson C. Perin MD, PhD , João AC Lima MD , Barry E. Hurwitz PhD , Dinesh Kalra MD , Gurnoor Singh MD , Russell G. Saltzman MPH , Lina V. Caceres MHS , Adriana Nettina MS , Yee-Shuan Lee PhD , Ketty Bacallao PhD , Edward Grant MPH , Aisha Khan PhD","doi":"10.1016/j.ahj.2025.107328","DOIUrl":"10.1016/j.ahj.2025.107328","url":null,"abstract":"<div><h3>Rationale</h3><div>To date, almost all studies of cell therapy in chronic heart failure (HF) have delivered cells transendocardially or intracoronarily and all have used a single cell dose, which limits therapeutic efficacy because transplanted cells disappear rapidly. Repeated administrations are necessary to replace the cells that disappear, but this is difficult or impossible when cells are delivered invasively. Further, transendocardial delivery is not feasible in many patients, carries risks, and requires specialized training and equipment, thereby limiting its widespread applicability. Intravenous infusion of cells is cheaper, simpler, safer, and less invasive; most importantly, it enables administration of multiple cell doses.</div></div><div><h3>Primary goal</h3><div>The CATO trial tests a new strategy–repeated intravenous infusions of cells in chronic HF. The goal is to determine whether intravenous cell therapy is beneficial and whether multiple cell doses are superior to a single dose. This trial is the culmination of a translational journey that began more than a decade ago in animal models of HF.</div></div><div><h3>Design</h3><div>CATO is a Phase IIA randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy of intravenous infusion of umbilical cord-derived mesenchymal stromal cells (UC-MSCs) in patients with ischemic HF. Sixty subjects will be randomized to 3 groups: control (placebo), 1 dose of UC-MSCs, or 4 repeated doses of UC-MSCs, with a comprehensive evaluation of cardiac function and structure, functional capacity, quality of life, and biomarkers over 12 months.</div></div><div><h3>Enrollment dates and current status</h3><div>CATO began enrollment on March 4, 2024. As of November 30, 2025, a total of 47 patients have been enrolled. Enrollment is expected to be completed by March 2026, and follow-up by March 2027.</div></div><div><h3>Significance</h3><div>CATO is the first trial of UC-MSCs for HF in the US, the first study of intravenous cell therapy for ischemic HF in the US, and the first randomized, double-blind, placebo-controlled trial of repeated cell doses for chronic HF. The 2 strategies tested in CATO (intravenous cell delivery and repeated doses) have the potential to be important advances in the management of HF</div></div><div><h3>Clinical Trial Registration</h3><div><span><span>Clinicaltrials.gov</span><svg><path></path></svg></span>, NCT06145035</div><div><span><span>https://clinicaltrials.gov/study/</span><svg><path></path></svg></span> NCT06145035.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107328"},"PeriodicalIF":3.5,"publicationDate":"2025-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145762079","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}
Pub Date : 2025-12-06DOI: 10.1016/j.ahj.2025.107325
Mathias Holm Sørgaard MD, PhD , Andreas Torp Kristensen MD , Kristian Eskesen MD, PhD , Klaus Fuglsang Kofoed MD, PhD, DMSc , Jesper James Linde MD, PhD , Henning Kelbæk , Michael Ottesen MD, PhD , Keld Neland MD, PhD , Charlotte Kragelund MD, PhD , Mette Lykke Norgaard Bertelsen MD, PhD , Jens Dahlgaard Hove MD, PhD , Gorm Mørk MD, PhD , Ole Peter Kristiansen MD, PhD , Thomas Engstrøm MD, PhD, DMSc , Jacob Thomsen Lønborg MD, PhD, DMSc , Jørgen Tobias Kühl MD, PhD, DMSc , Signe Stelling Risom RN, PhD , Paul Blanche MSc, PhD , Niels Thue Olsen MD, PhD
Purpose
In patients admitted with acute coronary syndrome, invasive coronary angiography (ICA) is performed to determine which patients need revascularization. Coronary computed tomography angiography (CCTA) offers a widely available, non-invasive alternative that could reduce patient discomfort, procedural risks, and healthcare costs. The current trial aims to determine whether CCTA is noninferior to ICA in determining the interventional strategy for patients admitted with non-ST elevation acute coronary syndrome (NSTE-ACS)(Central Illustration).
Methods
TRACTION (Team-based Interventional Triage in Acute Coronary Syndrome Based on Noninvasive Coronary Computed Tomography Angiography Versus Invasive Coronary Angiography) is a multicenter, randomized, open-label, noninferiority trial enrolling 2,300 patients. Patients hospitalized with non-ST elevation myocardial infarction or unstable angina with ischemic changes on ECG will be randomized 1:1 to CCTA vs ICA (standard of care). In the CCTA group, a Coronary Team reviews the CCTA and clinical information to determine the interventional strategy. The primary composite endpoint is major adverse cardiac events at 1 year, comprised of all-cause mortality, nonfatal myocardial infarction, hospitalization due to refractory angina, or hospitalization due to heart failure. Secondary outcomes include cardiovascular death, revascularization, symptom status, procedure-related adverse events, and resource utilization. The trial is designed to demonstrate noninferiority if the 95% confidence interval excludes an absolute risk difference of the primary endpoint larger than 5%.
Perspectives
If CCTA is shown to be noninferior to ICA in patients admitted with NSTE-ACS, CCTA could become the preferred management in a large group of patients. This could result in fewer patients exposed to invasive procedures and improved resource utilization.
{"title":"Coronary computed tomography angiography versus invasive coronary angiography for interventional triage in acute coronary syndrome: Design of the randomized TRACTION trial","authors":"Mathias Holm Sørgaard MD, PhD , Andreas Torp Kristensen MD , Kristian Eskesen MD, PhD , Klaus Fuglsang Kofoed MD, PhD, DMSc , Jesper James Linde MD, PhD , Henning Kelbæk , Michael Ottesen MD, PhD , Keld Neland MD, PhD , Charlotte Kragelund MD, PhD , Mette Lykke Norgaard Bertelsen MD, PhD , Jens Dahlgaard Hove MD, PhD , Gorm Mørk MD, PhD , Ole Peter Kristiansen MD, PhD , Thomas Engstrøm MD, PhD, DMSc , Jacob Thomsen Lønborg MD, PhD, DMSc , Jørgen Tobias Kühl MD, PhD, DMSc , Signe Stelling Risom RN, PhD , Paul Blanche MSc, PhD , Niels Thue Olsen MD, PhD","doi":"10.1016/j.ahj.2025.107325","DOIUrl":"10.1016/j.ahj.2025.107325","url":null,"abstract":"<div><h3>Purpose</h3><div>In patients admitted with acute coronary syndrome, invasive coronary angiography (ICA) is performed to determine which patients need revascularization. Coronary computed tomography angiography (CCTA) offers a widely available, non-invasive alternative that could reduce patient discomfort, procedural risks, and healthcare costs. The current trial aims to determine whether CCTA is noninferior to ICA in determining the interventional strategy for patients admitted with non-ST elevation acute coronary syndrome (NSTE-ACS)(<span><span>Central Illustration</span></span>).</div></div><div><h3>Methods</h3><div>TRACTION (Team-based Interventional Triage in Acute Coronary Syndrome Based on Noninvasive Coronary Computed Tomography Angiography Versus Invasive Coronary Angiography) is a multicenter, randomized, open-label, noninferiority trial enrolling 2,300 patients. Patients hospitalized with non-ST elevation myocardial infarction or unstable angina with ischemic changes on ECG will be randomized 1:1 to CCTA vs ICA (standard of care). In the CCTA group, a Coronary Team reviews the CCTA and clinical information to determine the interventional strategy. The primary composite endpoint is major adverse cardiac events at 1 year, comprised of all-cause mortality, nonfatal myocardial infarction, hospitalization due to refractory angina, or hospitalization due to heart failure. Secondary outcomes include cardiovascular death, revascularization, symptom status, procedure-related adverse events, and resource utilization. The trial is designed to demonstrate noninferiority if the 95% confidence interval excludes an absolute risk difference of the primary endpoint larger than 5%.</div></div><div><h3>Perspectives</h3><div>If CCTA is shown to be noninferior to ICA in patients admitted with NSTE-ACS, CCTA could become the preferred management in a large group of patients. This could result in fewer patients exposed to invasive procedures and improved resource utilization.</div><div>ClinicalTrials.gov identifier: NCT06101862</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107325"},"PeriodicalIF":3.5,"publicationDate":"2025-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145707173","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}
Pub Date : 2025-12-03DOI: 10.1016/j.ahj.2025.09.002
Dhruv Sarma BMBCh , Aniket S Rali MD , Jacob C Jentzer MD
{"title":"Response to letter by Golestanieraghi regarding article, “Association between vasopressin administration and mortality in patients with cardiogenic shock”","authors":"Dhruv Sarma BMBCh , Aniket S Rali MD , Jacob C Jentzer MD","doi":"10.1016/j.ahj.2025.09.002","DOIUrl":"10.1016/j.ahj.2025.09.002","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107270"},"PeriodicalIF":3.5,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145681383","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}
Pub Date : 2025-12-03DOI: 10.1016/j.ahj.2025.107286
Rosario Pivonello , Giorgio Arnaldi , Richard J. Auchus , Corin Badiu , Robert S. Busch , Salvatore Cannavo , Ulrich Dischinger , Georgiana A. Dobri , Diane Donegan , Atanaska Elenkova , Pouneh K. Fazeli , Richard A. Feelders , Rogelio Garcia-Centeno , Aleksandra Gilis-Januszewska , Oksana Hamidi , Zeina C. Hannoush , Harold J. Miller , Aurelian-Emil Ranetti , Monica Recasens , Martin Reincke , Andreas G. Moraitis
{"title":"Corrigendum to “Medical treatment of hypercortisolism with relacorilant: Final results of the phase 3 GRACE study” [American Heart Journal 278S (2024) Pages 10-11]","authors":"Rosario Pivonello , Giorgio Arnaldi , Richard J. Auchus , Corin Badiu , Robert S. Busch , Salvatore Cannavo , Ulrich Dischinger , Georgiana A. Dobri , Diane Donegan , Atanaska Elenkova , Pouneh K. Fazeli , Richard A. Feelders , Rogelio Garcia-Centeno , Aleksandra Gilis-Januszewska , Oksana Hamidi , Zeina C. Hannoush , Harold J. Miller , Aurelian-Emil Ranetti , Monica Recasens , Martin Reincke , Andreas G. Moraitis","doi":"10.1016/j.ahj.2025.107286","DOIUrl":"10.1016/j.ahj.2025.107286","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107286"},"PeriodicalIF":3.5,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145681385","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}
Pub Date : 2025-12-03DOI: 10.1016/j.ahj.2025.09.001
Niloufar Dadashpour MD, Majid Golestanieraghi MD
{"title":"Letter to the Editor regarding “Association between vasopressin administration and mortality in patients with cardiogenic shock”","authors":"Niloufar Dadashpour MD, Majid Golestanieraghi MD","doi":"10.1016/j.ahj.2025.09.001","DOIUrl":"10.1016/j.ahj.2025.09.001","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107269"},"PeriodicalIF":3.5,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145681379","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}
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