American heart journal最新文献

{"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 ,&nbsp;Jessica E. Teng MPH ,&nbsp;Silva A. Arslanian MD ,&nbsp;Andrew M. Atz MD ,&nbsp;Julie A. Brothers MD ,&nbsp;Mark J. Cartoski MD ,&nbsp;D’Andrea R. Freemon RN, MSN ,&nbsp;Sheela N. Magge MD MSCE ,&nbsp;William T. Mahle MD ,&nbsp;Michele Mietus-Snyder MD ,&nbsp;Amy Peterson MD MS ,&nbsp;Geetha Raghuveer MD MPH ,&nbsp;Mark W. Russell MD ,&nbsp;Amy S. Shah ,&nbsp;Craig A. Sponseller MD ,&nbsp;Mario Stylianou PhD ,&nbsp;Felicia L. Trachtenberg PhD ,&nbsp;Elaine M. Urbina MD MS ,&nbsp;Adam L. Ware MD ,&nbsp;Justin Zachariah MD MPH ,&nbsp;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":"2026-04-01","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}

{"title":"Response to the letter: Another perspective on democracy, healthcare and the public good","authors":"Richard C. Becker MD","doi":"10.1016/j.ahj.2025.107336","DOIUrl":"10.1016/j.ahj.2025.107336","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107336"},"PeriodicalIF":3.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145846506","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":"Dual versus monotherapy with SGLT2 inhibitor and GLP-1 receptor agonist: PRECIDENTD pragmatic randomized trial","authors":"Deborah J. Wexler MD, MSc ,&nbsp;Lindsay S. Mayberry PhD ,&nbsp;Lyndsay A. Nelson PhD ,&nbsp;Jeremy Lema-Driscoll BA ,&nbsp;Ligia C. Flores MS ,&nbsp;Maureen Malloy BS ,&nbsp;Jean G. MacFadyen BA ,&nbsp;Joseph Shen BS ,&nbsp;Elaine Zaharris BA ,&nbsp;Harsha Karanchi MD ,&nbsp;Ranee Chatterjee MD, MPH ,&nbsp;Catherine P. Benziger MD, MPH ,&nbsp;Jake E. Decker MD ,&nbsp;Rita Kalyani MD, MHS ,&nbsp;Camila Manrique-Acevedo MD, MHS ,&nbsp;Jacqueline Lonier MD ,&nbsp;Edward Simeone MA ,&nbsp;Kathleen Mieras BSAH ,&nbsp;Amanda R.O. Siqueira MD ,&nbsp;Russell L. Rothman MD, MPP ,&nbsp;Brendan M. Everett MD, MPH","doi":"10.1016/j.ahj.2025.107332","DOIUrl":"10.1016/j.ahj.2025.107332","url":null,"abstract":"<div><h3>Background</h3><div>Dual therapy with sodium-glucose co-transporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA) is frequently recommended. We compared rates of medication initiation and discontinuation between participants assigned to treatment with a single medication class or dual therapy in the feasibility phase of the PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes (PRECIDENTD) pragmatic trial.</div></div><div><h3>Methods</h3><div>PRECIDENTD randomly assigned participants with type 2 diabetes (T2D) and ASCVD or high ASCVD risk to fill prescriptions for SGLT2i, GLP-1RA, or dual therapy (1:1:1) using their own insurance. Analyses compared medication fill and discontinuation rates of assigned medication(s), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical and Mental Health Scores, and Modified Kansas City Cardiomyopathy Questionnaire (mKCCQ)-12 between the combined monotherapy (SGLT2i or GLP-1RA) and dual therapy (SGLT2i and GLP-1RA) groups.</div></div><div><h3>Results</h3><div>This report includes 173 insured participants [median age 67 years (IQR 62, 72), 46% female, 35% non-White, 67% with ASCVD]; 113 assigned to monotherapy and 60 to dual therapy. Monotherapy vs dual therapy fill rates were 84% vs 53% (<em>P</em> &lt; .001) 4 months after randomization and 87% vs 68% overall (<em>P</em> = .004) during 10-month median follow-up. Of those who filled medication, 22% in monotherapy and 49% in dual therapy discontinued a study medication (<em>P</em> = .002), mostly due to side effects. PROMIS and mKCCQ-12 scores showed no change.</div></div><div><h3>Conclusions</h3><div>Despite efforts to facilitate medication uptake in the feasibility phase of the PRECIDENTD pragmatic trial, barriers to initiation and ongoing use challenge the use of combination SGLT2i and GLP-1RA in T2D.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, NCT05390892, <span><span>https://clinicaltrials.gov/study/NCT05390892</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107332"},"PeriodicalIF":3.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145848819","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":"Comment on: Yoga vs regular exercise for atrial fibrillation: Design considerations for the yoga-AF randomized trial","authors":"Kotina Shridevi MD ,&nbsp;Rachna Rohtagi MS ,&nbsp;Kanishka Harariya MBBS ,&nbsp;Hariharan Srinivasan MD","doi":"10.1016/j.ahj.2025.107333","DOIUrl":"10.1016/j.ahj.2025.107333","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107333"},"PeriodicalIF":3.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145846542","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 HD PCI trial: A cluster randomized crossover trial of higher vs. lower dose heparin for elective percutaneous coronary intervention","authors":"Marc-André d’Entremont MD, MPH ,&nbsp;Shun Fu Lee PhD ,&nbsp;Harindra C. Wijeysundera MD, PhD ,&nbsp;Michael B. Tsang MD, MSc ,&nbsp;Shy Amlani MD ,&nbsp;Anthony Wassef MD, MSc ,&nbsp;Shahar Lavi MD ,&nbsp;Derek Y.F. So MD, MSc ,&nbsp;Jackie Betz BA ,&nbsp;Jessica Tyrwhitt BSc ,&nbsp;John Graham MD ,&nbsp;Warren J. Cantor MD ,&nbsp;Alireza Bagherli MD ,&nbsp;Ram Vijayaraghavan MD ,&nbsp;Sanjit S. Jolly MD MSc","doi":"10.1016/j.ahj.2025.107330","DOIUrl":"10.1016/j.ahj.2025.107330","url":null,"abstract":"<div><h3>Background</h3><div>Balancing ischemic versus bleeding complications following percutaneous coronary intervention (PCI) remains challenging. However, the optimal dose of unfractionated heparin (UFH) for elective PCI is currently unclear.</div></div><div><h3>Methods</h3><div>A Randomized Trial of Higher versus Lower Dose Heparin for PCI (HD-PCI) is a multicenter, randomized, controlled, registry-based, open-label, cluster crossover trial of a lower-dose (70 units/kg) versus higher-dose (100 units/kg) UFH dosing hospital-level policy for elective PCI conducted in 11 centres in Ontario, Canada. The primary efficacy outcome was defined as a composite of all-cause death, myocardial infarction or target vessel revascularization; the key safety outcome was defined as major bleeding; and the key net benefit outcome was defined as the composite of all-cause death, myocardial infarction, target vessel revascularization or major bleeding. All outcomes were evaluated within 30 days of the index PCI.</div></div><div><h3>Conclusions</h3><div>HD-PCI is a large cluster randomized crossover trial that will inform the ischemic and bleeding effects of lower-dose (70 units/kg) versus higher-dose (100 units/kg) in patients undergoing elective PCI.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov Identifier NCT04049591.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107330"},"PeriodicalIF":3.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145826820","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":"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 ,&nbsp;Trevor Ferguson DM, PhD ,&nbsp;Jose P. Lopez-Lopez MD ,&nbsp;Jacqueline Duncan MD, MPH ,&nbsp;Paola Lanza MD ,&nbsp;Allison Marshall PhD ,&nbsp;Mabel Reyes ,&nbsp;Jing Chen MD ,&nbsp;Amanda H. Anderson PhD ,&nbsp;Paul K. Whelton MD, MSc ,&nbsp;Althea Bailey PhD ,&nbsp;Carene Lindsay MSc ,&nbsp;Gregorio Sanchez MD ,&nbsp;Patricio Lopez-Jaramillo MD, PhD ,&nbsp;Marshall Tulloch-Reid MD, DSc ,&nbsp;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":"2026-04-01","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}

{"title":"Large-bore mechanical thrombectomy vs standard of care for acute high-risk pulmonary embolism: Rationale and design of the PERSEVERE randomized controlled trial","authors":"Romain Chopard MD, PhD ,&nbsp;Lukas Hobohm MD, PhD ,&nbsp;Stefano Barco MD, PhD ,&nbsp;Sripal Bangalore MD, MHA ,&nbsp;Jay Giri MD, MPH ,&nbsp;Felix Mahfoud MD ,&nbsp;John Moriarty MD ,&nbsp;Stephan Rosenkranz MD ,&nbsp;Andrew Sharp MD ,&nbsp;Holger Thiele MD ,&nbsp;Catalin Toma MD ,&nbsp;Victor F. Tapson MD ,&nbsp;Craig D. Markovitz PhD ,&nbsp;Stuart P. Rosenberg MS ,&nbsp;Stavros Konstantinides MD, PhD ,&nbsp;Nicolas Meneveau MD, PhD","doi":"10.1016/j.ahj.2025.107331","DOIUrl":"10.1016/j.ahj.2025.107331","url":null,"abstract":"<div><h3>Background</h3><div>Catheter-directed therapies are increasingly used to treat acute pulmonary embolism (PE). However, randomized data on reperfusion treatments, including large-bore mechanical thrombectomy (LBMT), for patients with High-Risk PE are lacking.</div></div><div><h3>Methods</h3><div>PERSEVERE (NCT06588634) is a multinational randomized controlled trial comparing the FlowTriever LBMT system vs. standard of care (SoC) in patients with High-Risk PE, with the modified intention-to-treat population planned for 200 patients from 40 sites in Europe and the US. Patients are randomized 1:1 to LBMT or SoC (systemic thrombolysis [ST], surgical embolectomy, extracorporeal membrane oxygenation [ECMO], or anticoagulation alone). Key inclusion criteria are the presence of proximal pulmonary thrombus on computed tomography plus ≥1 of the following: (1) systolic hypotension or need for vasopressors, (2) venous lactate ≥4 mmol/L with clinical signs suggesting obstructive shock, (3) need for mechanical circulatory support, (4) resuscitated cardiac arrest. Exclusion criteria include known chronic thromboembolic pulmonary hypertension and key absolute contraindications to ST. Patients are followed for 3 months. The primary endpoint is a composite of events through hospital discharge or 7 days post randomization, whichever occurs first: (1) all-cause death, (2) cardiac arrest requiring cardiopulmonary resuscitation, (3) bailout to rescue treatment, (4) major bleeding, and (5) ECMO in place on day 7. Secondary endpoints include a broad spectrum of functional and patient-reported outcomes (quality of life, functional status and healthcare resource utilization) at 3 months. The trial is funded by Inari.</div></div><div><h3>Conclusion</h3><div>The PERSEVERE study will assess the potential superiority of LBMT over SoC for the treatment of High-Risk PE.</div><div><span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> Identifier: NCT06588634.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107331"},"PeriodicalIF":3.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145843255","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":"Reproductive health outcomes of congenital heart disease survivors: A report from the congenital heart disease project to understand lifelong survivor experience (CHD PULSE study)","authors":"Sukran Erdem MD ,&nbsp;Caroline Yunhua Shi PhD ,&nbsp;Andrew Dailey Schwartz MD ,&nbsp;Jesica Flores MD ,&nbsp;Jessica Knight PhD ,&nbsp;Osamah Aldoss MD ,&nbsp;Susan C. Anderson BA ,&nbsp;Charles E. Canter MD ,&nbsp;Gurumurthy Hiremath MD ,&nbsp;Tarique Hussain MD, PhD ,&nbsp;Anitha S. John MD, PhD ,&nbsp;Bradley S. Marino MD ,&nbsp;Kimberly E. McHugh MD ,&nbsp;Geetha Raghuveer MD, MPH ,&nbsp;Logan G. Spector PhD ,&nbsp;James D. St Louis MD ,&nbsp;Lazaros Kochilas MD ,&nbsp;Matthew E. Oster MD ,&nbsp;Mansi Gaitonde MD","doi":"10.1016/j.ahj.2025.107338","DOIUrl":"10.1016/j.ahj.2025.107338","url":null,"abstract":"<div><h3>Background</h3><div>Improved survival of individuals with congenital heart disease (CHD) into adulthood has made reproductive health a crucial aspect of CHD care. Despite existing guidelines on heritability, contraception, pregnancy, and postpartum care, little is known about CHD survivors’ experiences and attitudes toward reproductive health. This study aimed to examine reproductive health outcomes and experiences among adults with CHD, with a focus on female survivors.</div></div><div><h3>Methods</h3><div>Data were drawn from the CHD PULSE (Project to Understand Lifelong Survivor Experience) study, a cross-sectional survey conducted from September 2021 to April 2023. Participants were adults (≥18 years) with at least 1 CHD intervention at 1 of 11 U.S. Pediatric Cardiac Care Consortium centers. CHD severity was categorized based on initial diagnosis and intervention. Categorical and continuous variables were analyzed using Chi-square and Kruskal-Wallis tests, respectively.</div></div><div><h3>Results</h3><div>Among 3,073 respondents (1,704 females, 1,369 males), 48% of female participants reported receiving no reproductive counseling. Factors significantly associated with receiving counseling included older age, later age at last surgery, marital history, severe CHD, higher income, government insurance, and more comorbidities (<em>P</em> &lt; .001). Women were significantly more likely to have biological children than men (40.4% vs 37.5%, <em>P</em> &lt; .0001).</div></div><div><h3>Conclusion</h3><div>Reproductive counseling is infrequent among women with CHD, especially among younger, unmarried, low-income individuals with less severe CHD and fewer comorbidities. Significant gender disparities in reproductive outcomes emphasize the need for tailored, gender-specific reproductive health counseling for CHD survivors.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107338"},"PeriodicalIF":3.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145931777","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 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 ,&nbsp;Xian-Liang Tang MD ,&nbsp;Joshua M. Hare MD ,&nbsp;Raul D. Mitrani MD ,&nbsp;Emerson C. Perin MD, PhD ,&nbsp;João AC Lima MD ,&nbsp;Barry E. Hurwitz PhD ,&nbsp;Dinesh Kalra MD ,&nbsp;Gurnoor Singh MD ,&nbsp;Russell G. Saltzman MPH ,&nbsp;Lina V. Caceres MHS ,&nbsp;Adriana Nettina MS ,&nbsp;Yee-Shuan Lee PhD ,&nbsp;Ketty Bacallao PhD ,&nbsp;Edward Grant MPH ,&nbsp;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":"2026-04-01","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}

{"title":"Response to comment on: Yoga vs regular exercise for atrial fibrillation – design considerations for the yoga-AF randomized trial","authors":"P.M. Kistler MBBS, PhD ,&nbsp;R. Crowley Bmed, MD","doi":"10.1016/j.ahj.2025.107335","DOIUrl":"10.1016/j.ahj.2025.107335","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"294 ","pages":"Article 107335"},"PeriodicalIF":3.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145888211","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}