American heart journal最新文献

{"title":"Potassium-competitive acid blocker versus proton-pump inhibitor in patients receiving antithrombotic therapy who are at high risk for gastrointestinal bleeding: Rationale and design of the randomized PROTECT- HBR trial","authors":"Jinho Lee MD ,&nbsp;Han-Su Park MD ,&nbsp;Junghoon Lee MD ,&nbsp;Kee Don Choi MD ,&nbsp;Do-Yoon Kang MD ,&nbsp;Jung-Min Ahn MD ,&nbsp;Weon Kim MD ,&nbsp;Jong-Young Lee MD ,&nbsp;Young-Hyo Lim MD ,&nbsp;Se Hun Kang MD ,&nbsp;Sung Uk Kwon MD ,&nbsp;Hanbit Park MD ,&nbsp;Eue-Keun Choi MD ,&nbsp;Soon Jun Hong MD ,&nbsp;Byeong-Keuk Kim MD ,&nbsp;Eun-Sun Jin MD ,&nbsp;Jin-Ok Jeong MD ,&nbsp;Chang-Wook Nam MD ,&nbsp;Wang Soo Lee MD ,&nbsp;Sang Min Kim MD ,&nbsp;Duk-Woo Park MD","doi":"10.1016/j.ahj.2025.04.001","DOIUrl":"10.1016/j.ahj.2025.04.001","url":null,"abstract":"<div><h3>Background</h3><div>Concomitant use of proton pump inhibitor (PPI) is recommended in patients receiving chronic antithrombotic therapy who are at high risk of gastrointestinal (GI) bleeding. However, long-term safety and efficacy of chronic PPI use have been concerned. Potassium-competitive acid blocker (P-CAB) is a novel class of acid suppressants, providing more acid stability, rapid onset of action, less variability with CYP2C19 polymorphisms, and longer duration of action than PPI.</div></div><div><h3>Design</h3><div>The PROTECT-HBR trial is a multicenter, randomized, double-blind, double-dummy, parallel-group clinical trial. Approximately 3320 patients with known cardiac or vascular disease receiving antithrombotic drugs (either antiplatelet or anticoagulant agents) and who are at high risk of GI bleeding will be randomized to P-CAB (tegoprazan 50mg once daily) or PPI (rabeprazole 20mg once daily) for up to 12 months. The primary endpoint is a composite outcome of upper GI clinical events, including overt or occult GI bleeding, symptomatic gastroduodenal ulcers or erosions, obstruction, or perforation, at 12 months. Secondary endpoints also included cardiovascular events and safety outcomes.</div></div><div><h3>Results</h3><div>As of December 2024, approximately 1460 patients were enrolled from 32 participating sites in South Korea. The complete enrollment is anticipated at the mid- or late-term of 2025, and the primary results will be available by 2027.</div></div><div><h3>Conclusion</h3><div>PROTECT-HBR is a large-scale, multicenter, clinical trial, which will provide a pivotal comparison of the efficacy and safety of novel P-CAB, tegoprazan with those of PPI, rabeprazole in patients with documented cardiac or vascular disease receiving chronic antithrombotic drugs and at high risk of GI bleeding.</div></div><div><h3>Clinical Trial Registration</h3><div>Potassium-Competitive Acid Blocker versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High GastroIntestinal Bleeding Risk Receiving Antithrombotic Therapy (PROTECT-HBR): NCT04416581.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"287 ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143794470","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":"Rationale and design of VICAD-RISK study: Visualization of coronary artery disease for modification of risk factors","authors":"Archana Kulasingam MD ,&nbsp;Sussie Laustsen MSN, PhD ,&nbsp;Martin Busk MD, PhD ,&nbsp;Niels-Peter Rønnow Sand MD, PhD ,&nbsp;Simon Winther MD, PhD, DMSci ,&nbsp;Kristian Kragholm MD, PhD ,&nbsp;Osama Hammid MD ,&nbsp;Kamilla Bech Pedersen ,&nbsp;Peter Vedsted MD, PhD ,&nbsp;Helle Kanstrup MD, PhD ,&nbsp;Martin Bødtker Mortensen MD, PhD ,&nbsp;Erik Lerkevang Grove MD, PhD ,&nbsp;Jesper Møller Jensen MD, PhD ,&nbsp;Bjarne Linde Nørgaard MD, PhD, DMSci","doi":"10.1016/j.ahj.2025.04.002","DOIUrl":"10.1016/j.ahj.2025.04.002","url":null,"abstract":"<div><h3>Background</h3><div>With the increasing use of coronary computed tomography angiography (CTA), the prevalence of patients with nonobstructive atherosclerotic coronary artery disease (NOCAD) is growing. Presence of NOCAD is associated with an increased risk of an unfavorable clinical outcome. Therefore, guideline-directed preventive strategies such as lipid-lowering therapy with statins are important. This study aims to assess whether visualization of personal CTA images to patients with a new diagnosis of NOCAD facilitates reduction of low-density lipoprotein (LDL) cholesterol (primary endpoint), improves statin adherence, influences the perception of statin-associated side effects, and modifies the coronary atherosclerotic phenotype.</div></div><div><h3>Methods</h3><div>The VICAD-RISK study is a Danish multicenter randomized trial including statin naïve patients suspected of chronic coronary syndrome with a new diagnosis of NOCAD determined by first-line coronary CTA. A total of 273 patients will be randomized 1:1:1 into; (1) usual care; representing current clinical practice of general practitioner follow-up; (2) low-intensity intervention; specialized nurse consultation, or (3) high-intensity intervention; similar to group 2 and presentation of the personal CTA-images. All participants, including the intervention groups, will be followed at the discretion of their general practitioner. Research follow-up including biochemistry measurements, and coronary CTA investigation will be repeated for all participants after 12 months.</div></div><div><h3>Conclusion</h3><div>The VICAD-RISK study evaluates whether personal CTA image visualization in patients with a new diagnosis of NOCAD improves reduction of LDL cholesterol.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov, NCT06413641, <span><span>www.clinicaltrials.gov</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"287 ","pages":"Pages 16-23"},"PeriodicalIF":3.7,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787552","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":"Cost-effectiveness of the transition from Conventional to High-Sensitivity Troponin Assay for the Investigation and Management of Suspected Acute Coronary Syndrome in the Emergency Department.","authors":"Aubyn Pincombe, Jodi Gray, Siobhan Hickling, Frank Sanfilippo, Tom Briffa, Louise Cullen, Derek Chew, Graham Hillis, Daniel Fatovich, Jamie Rankink, Lee Nedkoff, Samuel Scanlan, Peter E Hickman, Stuart Stapleton, Will Parsonage, Biswadev Mitra, Hans G Schneider, Garry Wilkes, Teagan Robinson, Jon Karnonu","doi":"10.1016/j.ahj.2025.03.022","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.03.022","url":null,"abstract":"<p><strong>Background: </strong>Switching from conventional to high-sensitivity cardiac troponin (hs-cTn) assays with sex-specific reference rates for threshold troponin levels enables detection of smaller amounts of myocardial damage. However, the real-world impact of these assays on patient outcomes and health service costs is poorly understood. We investigated the cost-effectiveness of switching to hs-cTn assays for patients presenting to Australian Emergency Departments (EDs) with suspected acute coronary syndrome (ACS) with a 12-month follow-up period.</p><p><strong>Methods: </strong>Using linked administrative data from nine tertiary hospitals for patients aged 20 and above who presented to ED with suspected ACS between March 2011 and November 2015, we applied a difference-in-differences methodology to compare costs and major adverse cardiac events between hospitals switching to hs-cTn assays and hospitals continuing to use conventional assays.</p><p><strong>Results: </strong>We identified 179,681 consecutive patients, of whom 87,019 presented during the pre-period and 92,662 the post-period. Switching to hs-cTn was associated with a reduction in the cost of the index event (-$1,022, 95% CI: -$1,034, -$1,009), a reduction in total costs at 12 months (-$1,373, 95% CI: -$1,387, -$1,360) and a reduction in the percentage of patients experiencing a MACE outcome within 12-months (-0.55%, 95% CI: -0.88%, -0.21%). The reduction in MACE outcomes was larger for female patients (-1.17%, 95% CI: -1.19%, -1.14%) than for all patients and for males.</p><p><strong>Conclusion: </strong>The switch to hs-cTn is highly cost-effective across all patients and for each sex. The reduction in MACE outcomes and costs within 12 months are greater for females than for males.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787547","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 Lp(a)HORIZON Trial: Assessing the Effect of Lipoprotein(a) Lowering With Pelacarsen on Major Cardiovascular Events in Patients With CVD and Elevated Lp(a)","authors":"Leslie Cho MD ,&nbsp;Stephen J. Nicholls MBBS, PhD ,&nbsp;Børge G. Nordestgaard MD, DMSc ,&nbsp;Ulf Landmesser MD ,&nbsp;Sotirios Tsimikas MD ,&nbsp;Michael J. Blaha MD, MPH ,&nbsp;Eran Leitersdorf MD ,&nbsp;A. Michael Lincoff MD ,&nbsp;Anastasia Lesogor MD ,&nbsp;Brian Manning Pharm D ,&nbsp;Plamen Kozlovski MD ,&nbsp;Hui Cao MD ,&nbsp;Jing Wang MD, PhD ,&nbsp;Steven E. Nissen MD","doi":"10.1016/j.ahj.2025.03.019","DOIUrl":"10.1016/j.ahj.2025.03.019","url":null,"abstract":"<div><h3>Background</h3><div>Lipoprotein(a), abbreviated Lp(a), consists of apolipoprotein B-100 covalently bound to apolipoprotein(a), and represents an independent, genetically-determined, causal risk factor for atherosclerotic cardiovascular disease (CVD) and calcific aortic stenosis. More than 20% of the world CVD population has elevated Lp(a). Currently there are no approved pharmacologic treatments to lower Lp(a) levels, and no randomized trials have demonstrated that lowering Lp(a) reduces CVD risk.</div></div><div><h3>Study Design</h3><div>Lp(a) HORIZON is a phase 3, randomized, placebo-controlled, double-blind, parallel-group, multinational trial in 8,323 patients with established CVD and elevated Lp(a) levels of ≥70 mg/dL (approximately 149 nmol/L), testing the effect of pelacarsen, an antisense oligonucleotide (ASO) on the incidence of major adverse cardiovascular events (MACE). Established CVD is defined as history of myocardial infarction (MI), ischemic stroke or symptomatic peripheral artery disease. The minimum follow-up is required to be 2.5 years. The study will end when 993 CEC confirmed primary CV events have accumulated. Based on the current event accrual trend, the overal study duration is anticipated to be approximately 6 years. Patients were randomized in a 1:1 ratio to receive either monthly subcutaneous (SQ) injections of pelacarsen 80 mg or matching placebo on a background of optimized standard of care therapy for CVD. The primary endpoint is a composite of cardiovascular death, nonfatal MI, nonfatal stroke, or urgent coronary revascularization requiring hospitalization. This endpoint will be evaluated in the overall population and in a subpopulation of Lp(a) ≥90 mg/dL (approximately 192 nmol/L) at screening, with multiplicity control designed to test the primary endpoint in both the overall population and the subpopulation.</div></div><div><h3>Conclusion</h3><div>Lp(a) HORIZON will determine the effect of pelacarsen on cardiovascular morbidity and mortality in patients with elevated Lp(a) and established CVD.</div></div><div><h3>Trial Registration</h3><div>NCT 04023552.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"287 ","pages":"Pages 1-9"},"PeriodicalIF":3.7,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787550","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":"Rationale and design of NUDGE-CKD: A nationwide randomized factorial trial of electronic nudges for increasing guideline-directed medical therapy in chronic kidney disease","authors":"Kristoffer Grundtvig Skaarup MD ,&nbsp;Niklas Dyrby Johansen MD PhD ,&nbsp;Lisbet Brandi MD ,&nbsp;Morten Kofod Lindhardt MD ,&nbsp;Jesper N. Bech MD ,&nbsp;My Svensson MD ,&nbsp;Tilde Kristensen MD ,&nbsp;Anne Daugaard Thuesen MD PhD ,&nbsp;Majbritt Grønborg Knudsen MD ,&nbsp;Jan Dominik Kampmann MD ,&nbsp;Mads Hornum MD ,&nbsp;Birgitte Ørts MA ,&nbsp;Daniel Modin MD ,&nbsp;Mats C.H. Lassen MD ,&nbsp;Kira Hyldekær Janstrup PhD ,&nbsp;Brian L. Claggett PhD ,&nbsp;Muthiah Vaduganathan MD MPH ,&nbsp;Ankeet S. Bhatt MD MBA ScM ,&nbsp;Harriette Van Spall MD ,&nbsp;Jens Ulrik Stæhr Jensen MD PhD ,&nbsp;Tor Biering-Sørensen MD MPH MSc PhD","doi":"10.1016/j.ahj.2025.03.015","DOIUrl":"10.1016/j.ahj.2025.03.015","url":null,"abstract":"<div><h3>Background</h3><div>Treatment guidelines for chronic kidney disease (CKD) recommend sodium-glucose cotransporter 2 inhibitors (SGLT2i) as first-line treatment for a broad range of individuals with CKD, alongside renin-angiotensin system inhibitors (RASi). However, adoption of guidelines in clinical practice is often delayed, potentially leading to avoidable associated morbidity and mortality. Effective strategies are needed to improve implementation of guideline-directed medical therapy (GDMT) in patients with CKD. This trial will evaluate the effectiveness of electronic letter-based nudges, delivered via the Danish governmental electronic letter system to individuals with CKD, their general practices, or both, in increasing GDMT in individuals with CKD.</div></div><div><h3>Methods</h3><div>NUDGE-CKD is a 2 × 2 factorial, nationwide implementation trial, with randomization at both the general practice and patient level. All Danish citizens with CKD and access to the official Danish electronic letter system were randomized in a 1:1 ratio to usual care (no letter) or to receive an electronic letter-based nudge on GDMT in CKD. All Danish general practices with a patient with CKD on their patient panel were also randomized 1:1 to usual care (no letter) or to receive an electronic informational nudge letter on GDMT in CKD. Data are collected through the Danish administrative health registries. The primary endpoint is a prescription of RASi or SGLT2i within 6 months of intervention delivery based on fill records. Secondary endpoints include components of the primary endpoint, as well as proportion of new CKD GDMT users. Prespecified exploratory endpoints include filled prescriptions of other cardio-renal-protective medications, general practice contacts, assessment of renal biomarkers and downstream clinical outcomes. A total 22,617 individuals with CKD were randomized to the patient-level intervention, and 28,069 individuals with CKD across 1,540 general practices were randomized to the general practice-level intervention. Intervention letters were delivered on August 19, 2024, and follow-up is currently ongoing (end of follow-up for primary endpoint: February 19, 2025).</div></div><div><h3>Discussion</h3><div>NUDGE-CKD is the first nationwide randomized trial of electronic letter-based nudges delivered to individuals with CKD and their general practices to increase uptake of GDMT in individuals with CKD. The trial will provide evidence into the usefulness of direct communication with patients and healthcare providers for real-world implementation of GDMT.</div></div><div><h3>Trial Registration</h3><div>Clinicaltrials.gov: NCT06300086, registered March 7, 2024 (<span><span>https://clinicaltrials.gov/study/NCT06300086</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"287 ","pages":"Pages 61-78"},"PeriodicalIF":3.7,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143770865","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 prospective, multicenter, randomized controlled trial evaluating anticoagulation alone vs anticoagulation plus computer assisted vacuum thrombectomy for the treatment of intermediate-high-risk acute pulmonary embolism: Rationale and design of the STORM-PE study","authors":"Rachel P. Rosovsky MD, MPH ,&nbsp;Stavros V. Konstantinides MD, FESC ,&nbsp;John M. Moriarty MD ,&nbsp;Suhail Y. Dohad MD ,&nbsp;Ido Weinberg MD ,&nbsp;Sahil A. Parikh MD ,&nbsp;Richard Channick MD ,&nbsp;Robert A Lookstein MD","doi":"10.1016/j.ahj.2025.03.018","DOIUrl":"10.1016/j.ahj.2025.03.018","url":null,"abstract":"<div><h3>Background</h3><div>Therapeutic anticoagulation (AC) is standard care for pulmonary embolism (PE). Endovascular therapy with mechanical thrombectomy (MT) is commonly performed for PE and well-studied in single-arm trials. The efficacy benefit of MT over AC alone in a randomized fashion remains unstudied.</div></div><div><h3>Methods and results</h3><div>STORM-PE (ClinicalTrials.gov Identifier: NCT05684796) is a post-market, international, open-label trial conducted in partnership with The Pulmonary Embolism Response Team Consortium. Up to 100 patients with confirmed acute intermediate-high-risk PE demonstrated by right ventricular (RV) dysfunction with a right-to-left ventricular (RV/LV) ratio ≥1.0 and elevated cardiac biomarkers will be randomized 1:1 to receive AC alone or AC plus computer assisted vacuum thrombectomy (CAVT) with the Indigo Aspiration System (Penumbra Inc.). The primary outcome is a mean change in RV/LV ratio at 48 hours, assessed by computed tomographic pulmonary angiography (CTPA) and adjudicated by a blinded, independent imaging Core Lab. Additional endpoints are composite major adverse events, functional outcomes (6-minute walk test, New York Heart Association classification, post-venous thromboembolism functional status scale, modified Medical Research Council Dyspnea Scale, Borg Scale), quality of life (Pulmonary Embolism Quality of Life Questionnaire and EQ-5D-5L), mortality, and symptomatic PE recurrence through 90 days. A Clinical Events Committee will adjudicate adverse events for causality and attribution and an independent Data Safety Monitoring Board will oversee the study. STORM-PE is funded by Penumbra Inc.</div></div><div><h3>Conclusions</h3><div>The STORM-PE trial will help inform future guidelines and standards of care related to frontline treatment using mechanical thrombectomy with CAVT for patients with acute intermediate-high-risk PE.</div></div><div><h3>Trial Registration</h3><div>STORM-PE, NCT05684796, is registered at <span><span>https://clinicaltrials.gov/study/NCT05684796</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"288 ","pages":"Pages 1-14"},"PeriodicalIF":3.7,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143771223","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":"Effects of angiotensin-neprilysin inhibition in women versus men: Insights from PARAGLIDE-HF.","authors":"Paula Rambarat, Tyler Erickson, Derek Cyr, Jonathan Ward, Adrian Hernandez, David Morrow, Randall Starling, Eric Velazquez, Shelley Zieroth, Kristin Williamson, Scott Solomon, Robert Mentz","doi":"10.1016/j.ahj.2025.03.017","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.03.017","url":null,"abstract":"<p><strong>Background: </strong>Sub-analyses of key trials suggest a preferential benefit for specific heart failure with preserved ejection fraction (HFpEF) therapies in women. This work investigated treatment effects between women and men in the PARAGLIDE-HF (Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF) trial.</p><p><strong>Methods: </strong>In this pre-specified subgroup analysis, we examined outcomes according to sex in the PARAGLIDE-HF trial. The primary endpoint was time-average proportional change in amino terminal pro-B type natriuretic peptide (NT-proBNP) from baseline through Weeks 4 and 8. We also examined secondary outcomes and tolerability.</p><p><strong>Results: </strong>Overall, 242 women (52%) and 224 men (48%) were randomized. Women had significantly higher LVEF, worse renal function, and less comorbidities than men. In the overall population, the time-averaged reduction in NT-proBNP was significantly greater for sacubitril/valsartan (sac/val) than valsartan (ratio of change 0.85, 95% CI:0.73-0.999). When examined according to sex, the time-averaged reduction in NT-proBNP was numerically greater with sac/val in both women (ratio of change=0.86, 95% CI: 0.69-1.070) and men (ratio of change 0.84, 95% CI: 0.67-1.05) with no differential treatment effect (P interaction=0.91). Similarly, the secondary hierarchical endpoint favored sac/val over valsartan in both women and men but was not statistically significant. Study drug dosage levels were similar across women and men and there were no sex-specific differences in the incidence of adverse events.</p><p><strong>Conclusions: </strong>In patients with mildly reduced or preserved EF > 40% and a recent worsening HF event, the efficacy, safety and tolerability of sac/val versus valsartan were similar in both women and men, suggesting consistent effects across appropriately selected patients regardless of sex. Future prospective studies are needed to further evaluate sex-specific differences in treatment response of HFpEF therapies.</p><p><strong>Trial registration: </strong>Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF; NCT03988634; https://www.</p><p><strong>Clinicaltrials: </strong>gov/study/NCT03988634.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143770852","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 series of randomized trials of behavioral economic interventions to increase racial and ethnic diversity of research participants: Rationale and design of ITERATE","authors":"Nirali Patel BS, BA ,&nbsp;Casey Whitman MS ,&nbsp;Adina Lieberman MPH ,&nbsp;Shira Blady BS ,&nbsp;Colleen Morse PT, DPT, MSA ,&nbsp;Nawar Naseer PhD, MPH ,&nbsp;Joellen Weaver MT (ASCP) ,&nbsp;Modele O. Ogunniyi MD, MPH ,&nbsp;Rachel Kohn MD, MSCE ,&nbsp;Kevin G. Volpp MD, PhD ,&nbsp;Scott D. Halpern MD, PhD ,&nbsp;Alanna A. Morris MD, MSc ,&nbsp;Alisa Stephens-Shields PhD ,&nbsp;Alexander C. Fanaroff MD, MHS","doi":"10.1016/j.ahj.2025.03.016","DOIUrl":"10.1016/j.ahj.2025.03.016","url":null,"abstract":"<div><h3>Rationale</h3><div>Prospective clinical research studies are essential for determining the effectiveness and safety of drugs, medical devices, and healthcare delivery interventions. However, low enrollment, particularly among Black and Hispanic patients, challenges the generalizability of results and fairness of research. Leveraging insights from behavioral economics to modify the content of messages recruiting patients to join research studies may increase enrollment and representativeness of trial populations.</div></div><div><h3>Primary hypothesis</h3><div>Method of outreach, source of outreach, message framing, and financial incentives will have important effects on enrollment fraction of Black and Hispanic patients electronically approached for participation in a prospective clinical research study.</div></div><div><h3>Design</h3><div>ITERATE (NCT05827718) is a series of 4 randomized clinical trials (RCTs) designed to rigorously, systematically, and iteratively test the effects of different messaging strategies informed by behavioral economic theory on the enrollment of Black and Hispanic individuals into the Penn Medicine BioBank (PMBB), a prospective registry. For all 4 RCTs, we will identify patients eligible for enrollment in the PMBB (those with ≥ 1 encounter with the University of Pennsylvania Health System in the past 3 months, a phone number able to receive text messages or a valid email address on file, no history of consenting to or declining enrollment in the PMBB, and able to provide their own consent) and randomly assign them to receive different outreach messages. RCT 1 will test the method of outreach (email vs. text message vs. email + text message); RCT 2, source of outreach (research team vs. clinical team); RCT 3, message framing (appeal to altruism vs. appeal to social proof vs. control); and RCT 4, financial incentive (none vs. medium guarantee vs. small guarantee + small lottery vs. medium lottery vs. large lottery). In each RCT, at least 50% of the participants will be Black or Hispanic. The primary outcome of each RCT is enrollment fraction, defined as the number of participants who enroll in the PMBB divided by the total number of participants who received an outreach message, compared between arms among both Black and Hispanic patients. Secondary outcomes will include overall enrollment fraction and enrollment fraction among White patients. The “winning” strategies in earlier RCTs will be incorporated as the “standard of care” in the subsequent RCTs.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"286 ","pages":"Pages 80-87"},"PeriodicalIF":3.7,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143750736","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 as a biological variable: a contemporary perspective","authors":"Fatima Farrukh MD,&nbsp;Richard C. Becker MD","doi":"10.1016/j.ahj.2025.03.012","DOIUrl":"10.1016/j.ahj.2025.03.012","url":null,"abstract":"<div><h3>Background</h3><div>Incorporating sex as a biological variable (SABV) in biomedical research is essential to enhancing the translational relevance of scientific findings and ensuring equitable healthcare for both sexes. Despite policy advancements, disparities persist in the integration of SABV across research domains, particularly in cardiovascular disease, where presentation and treatment responses vary by sex.</div></div><div><h3>Methods</h3><div>This review synthesizes current literature and policy frameworks, including the NIH SABV mandate, to evaluate progress in SABV implementation. It also examines the roles of key stakeholders—funding agencies, publishers, and the pharmaceutical industry—in promoting or hindering SABV integration in preclinical and clinical research.</div></div><div><h3>Results</h3><div>Analysis reveals variable adherence to SABV policies, with persistent gaps in both study design and reporting. Case studies in cardiovascular research illustrate the consequences of SABV neglect, such as misdiagnosis and suboptimal treatment strategies. Positive shifts are observed in areas with strong policy enforcement and targeted funding incentives.</div></div><div><h3>Conclusions</h3><div>Effective integration of SABV is critical for scientific rigor and healthcare equity. Strategies such as mandatory researcher training, policy accountability measures, and increased sex-disaggregated data reporting are needed. Emphasizing SABV in clinical trial design and analysis will help foster a more inclusive research environment and improve health outcomes for all.</div></div><div><h3>Trial Registration</h3><div>Not applicable.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"287 ","pages":"Pages 10-15"},"PeriodicalIF":3.7,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143750737","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":"HELicobacter Pylori screening to prevent gastrointestinal bleeding in patients with acute Myocardial Infarction (HELP-MI SWEDEHEART) - Design and rationale of a cluster randomized, crossover, registry-based clinical trial","authors":"Robin Hofmann MD, PhD ,&nbsp;Stefan James MD, PhD ,&nbsp;Martin O. Sundqvist MD ,&nbsp;Jonatan Wärme MD ,&nbsp;Ole Fröbert MD, PhD ,&nbsp;Oskar Angerås MD, PhD ,&nbsp;Per M. Hellström MD, PhD ,&nbsp;Kristina Hambraeus MD, PhD ,&nbsp;Joakim Alfredsson MD, PhD ,&nbsp;David Erlinge MD, PhD ,&nbsp;Jörg Lauermann MD, PhD ,&nbsp;Lars Lindhagen PhD ,&nbsp;Ollie Östlund PhD ,&nbsp;Tomas Jernberg MD, PhD ,&nbsp;Magnus Bäck MD, PhD","doi":"10.1016/j.ahj.2025.03.014","DOIUrl":"10.1016/j.ahj.2025.03.014","url":null,"abstract":"<div><h3>Background</h3><div>The role of <em>Helicobacter pylori</em> (<em>H. pylori</em>) screening and eradication on reducing upper gastrointestinal bleeding (UGIB) complications after acute myocardial infarction (MI) is uncertain. The HELicobacter pylori screening to prevent gastrointestinal bleeding in patients with acute MI (HELP-MI SWEDEHEART) trial aims to determine whether systematic <em>H. pylori</em> screening compared to usual care reduces UGIB, mortality, and cardiovascular outcomes after MI.</div></div><div><h3>Methods</h3><div>A cluster randomized, crossover, registry-based clinical trial using SWEDEHEART as trial platform for study population definition and source for data collection in combination with nationwide Swedish health data registries. Thirty-five Swedish hospitals, organized into 18 clusters based on percutaneous coronary intervention networks, were randomized to either routine <em>H. pylori</em> screening for adults with acute type-1 MI or usual care. After 1 year, a 2-month blanking period was followed by a crossover to the alternate allocation for 1 year. The trial enrolment was concluded after one additional year of registry-based follow-up. The primary endpoint is UGIB. Secondary endpoints include all-cause death, cardiovascular death, readmission for MI, stroke, or heart failure. Endpoints will be reported combined (Net Adverse Clinical Events; Major Adverse Cardiac or Cerebrovascular Events) and separately. The primary analysis will include all available follow-up time corresponding to a maximum follow-up time of 3 years and 2 months.</div></div><div><h3>Conclusion</h3><div>HELP-MI SWEDEHEART aims to determine the utility of routine <em>H. pylori</em> screening to reduce UGIB and improve cardiovascular outcomes after MI. By integrating national registry follow-up data with a pragmatic trial design, it has the potential to provide evidence for the effect of the implementation of routine <em>H. pylori</em> screening as part of acute MI care.</div></div><div><h3>Trial Registration</h3><div>ClinicalTrials.gov, NCT05024864.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"286 ","pages":"Pages 66-74"},"PeriodicalIF":3.7,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742012","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}