Kristoffer Grundtvig Skaarup, Niklas Dyrby Johansen, Lisbet Brandi, Morten Kofod Lindhardt, Jesper N Bech, My Svensson, Tilde Kristensen, Anne Daugaard Thuesen, Majbritt Grønborg Knudsen, Jan Dominik Kampmann, Mads Hornum, Birgitte Ørts, Daniel Modin, Mats C H Lassen, Kira Hyldekær Janstrup, Brian L Claggett, Muthiah Vaduganathan, Ankeet S Bhatt, Harriette Van Spall, Jens Ulrik Stæhr Jensen, Faiez Zannad, Scott D Solomon, Anne Møller, Rikke Borg, Henrik Birn, Ditte Hansen, Tor Biering-Sørensen
{"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, Niklas Dyrby Johansen, Lisbet Brandi, Morten Kofod Lindhardt, Jesper N Bech, My Svensson, Tilde Kristensen, Anne Daugaard Thuesen, Majbritt Grønborg Knudsen, Jan Dominik Kampmann, Mads Hornum, Birgitte Ørts, Daniel Modin, Mats C H Lassen, Kira Hyldekær Janstrup, Brian L Claggett, Muthiah Vaduganathan, Ankeet S Bhatt, Harriette Van Spall, Jens Ulrik Stæhr Jensen, Faiez Zannad, Scott D Solomon, Anne Møller, Rikke Borg, Henrik Birn, Ditte Hansen, Tor Biering-Sørensen","doi":"10.1016/j.ahj.2025.03.015","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.03.015","url":null,"abstract":"<p><strong>Rationale: </strong>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.</p><p><strong>Aims: </strong>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.</p><p><strong>Design: </strong>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).</p><p><strong>Discussion: </strong>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.</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":"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}
Rachel P Rosovsky, Stavros V Konstantinides, John M Moriarty, Suhail Y Dohad, Ido Weinberg, Sahil A Parikh, Richard Channick, Robert A Lookstein
{"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, Stavros V Konstantinides, John M Moriarty, Suhail Y Dohad, Ido Weinberg, Sahil A Parikh, Richard Channick, Robert A Lookstein","doi":"10.1016/j.ahj.2025.03.018","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.03.018","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods and results: </strong>STORM-PE (ClinicalTrials.gov Identifier: NCT05684796) is a post-market, international, open-label trial conducted in partnership with The Pulmonary Embolism Response Team Consortium<sup>TM</sup>. 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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>STORM-PE, NCT05684796, is registered at https://clinicaltrials.gov/study/NCT05684796.</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":"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}
Paula Rambarat, Tyler Erickson, Derek Cyr, Jonathan Ward, Adrian Hernandez, David Morrow, Randall Starling, Eric Velazquez, Shelley Zieroth, Kristin Williamson, Scott Solomon, Robert Mentz
{"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}
Nirali Patel, Casey Whitman, Adina Lieberman, Shira Blady, Colleen Morse, Nawar Naseer, Joellen Weaver, Modele O Ogunniyi, Rachel Kohn, Kevin G Volpp, Scott D Halpern, Alanna A Morris, Alisa Stephens-Shields, Alexander C Fanaroff
{"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, Casey Whitman, Adina Lieberman, Shira Blady, Colleen Morse, Nawar Naseer, Joellen Weaver, Modele O Ogunniyi, Rachel Kohn, Kevin G Volpp, Scott D Halpern, Alanna A Morris, Alisa Stephens-Shields, Alexander C Fanaroff","doi":"10.1016/j.ahj.2025.03.016","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.03.016","url":null,"abstract":"<p><strong>Rationale: </strong>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.</p><p><strong>Primary hypothesis: </strong>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.</p><p><strong>Design: </strong>ITERATE (NCT05827718) is a series of four 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 four 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.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"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, Richard C Becker","doi":"10.1016/j.ahj.2025.03.012","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.03.012","url":null,"abstract":"<p><p>This review discusses the significance of incorporating sex as a biological variable (SABV) in biomedical research to enhance the translational value of findings and improve healthcare outcomes for both sexes. We review foundational policies, such as the NIH SABV mandate, and assess progress in integrating SABV in preclinical and clinical research. By highlighting disparities in cardiovascular disease presentation and treatment responses, as well as the pivotal roles of funding agencies, publishers, and the pharmaceutical industry, we underscore the necessity of SABV for equitable and effective healthcare. Strategies for advancing SABV integration, including mandatory training, policy enforcement, and clinical trial participation, are proposed to foster a research environment that prioritizes inclusivity and scientific rigor.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"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}
Robin Hofmann, Stefan James, Martin O Sundqvist, Jonatan Wärme, Ole Fröbert, Oskar Angerås, Per M Hellström, Kristina Hambraeus, Joakim Alfredsson, David Erlinge, Jörg Lauermann, Lars Lindhagen, Ollie Östlund, Tomas Jernberg, Magnus Bäck
{"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, Stefan James, Martin O Sundqvist, Jonatan Wärme, Ole Fröbert, Oskar Angerås, Per M Hellström, Kristina Hambraeus, Joakim Alfredsson, David Erlinge, Jörg Lauermann, Lars Lindhagen, Ollie Östlund, Tomas Jernberg, Magnus Bäck","doi":"10.1016/j.ahj.2025.03.014","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.03.014","url":null,"abstract":"<p><strong>Background: </strong>The role of Helicobacter pylori (H. pylori) 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 H. pylori screening compared to usual care reduces UGIB, mortality, and cardiovascular outcomes after MI.</p><p><strong>Methods: </strong>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 H. pylori screening for adults with acute type-1 MI or usual care. After one year, a 2-month blanking period was followed by a crossover to the alternate allocation for one 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.</p><p><strong>Conclusion: </strong>HELP-MI SWEDEHEART aims to determine the utility of routine H. pylori 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 H. pylori screening as part of acute MI care.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT05024864.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"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}
Yiming Chen MS , John Lawrence PhD , Norman Stockbridge MD, PhD
{"title":"Corrigendum to “Days alive out of hospital in heart failure: Insights from the PARADIGM-HF and CHARM trials” [Am Heart J 241 (2021) 108-119]","authors":"Yiming Chen MS , John Lawrence PhD , Norman Stockbridge MD, PhD","doi":"10.1016/j.ahj.2025.03.007","DOIUrl":"10.1016/j.ahj.2025.03.007","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"285 ","pages":"Page 105"},"PeriodicalIF":3.7,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143704537","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Navid Noory, Oscar Westin, Eva Havers Borgersen, Charlotte Kragelund, Jens Dahlgaard Hove, Matthew S Maurer, Lars Køber, Finn Gustafsson, Emil Fosbøl
{"title":"Absence of Coronary Artery Disease in Patients Undergoing Coronary Imaging and Association with Amyloidosis - A Danish Nationwide Study.","authors":"Navid Noory, Oscar Westin, Eva Havers Borgersen, Charlotte Kragelund, Jens Dahlgaard Hove, Matthew S Maurer, Lars Køber, Finn Gustafsson, Emil Fosbøl","doi":"10.1016/j.ahj.2025.03.011","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.03.011","url":null,"abstract":"<p><p>This nationwide registry-based study in Denmark revealed a higher 10-year cumulative incidence of amyloidosis among 79,443 coronary artery disease-negative patients compared to matched controls, with an adjusted hazard ratio of 7.43 [95% CI 4.01-13.7]. These findings warrant prospective studies to investigate the prevalence of amyloidosis in patients negative for coronary artery disease after coronary examination.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742006","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}
Uwe Zeymer, Fathema Hassinger, Peter Bramlage, Andreas Schäfer, Dirk Westermann, Holger Thiele
{"title":"Hyperoxemic Oxygen Therapy in Patients with Acute Anterior Myocardial Infarction: HOT-AAMI - Design and Rationale of a Randomized Trial.","authors":"Uwe Zeymer, Fathema Hassinger, Peter Bramlage, Andreas Schäfer, Dirk Westermann, Holger Thiele","doi":"10.1016/j.ahj.2025.03.013","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.03.013","url":null,"abstract":"<p><strong>Background: </strong>Patients with acute anterior ST-elevation myocardial infarction (STEMI) are at high risk for death and heart failure (HF) despite treatment with primary percutaneous coronary intervention (PCI). Adjunctive therapy with hyperoxemic supersaturated oxygen (SSO2) following PCI reduced infarct size in previous randomized trials, but none of these trials were powered for clinical endpoints.</p><p><strong>Aims: </strong>The HOT-AAMI trial evaluates whether hyperoxemic supersaturated oxygen (SSO2) therapy following PCI reduces the risk of death and heart failure.</p><p><strong>Methods: </strong>HOT-AAMI is a multicenter, 1:1 randomized, open-label study across 50 sites in Germany. Patients presenting with anterior STEMI and undergoing successful PCI of the left anterior descending artery are randomized to receive SSO2 therapy on top of standard care or standard of care alone. The primary endpoint is a composite of all-cause mortality or unplanned heart failure hospital admission or outpatient visit due to heart failure requiring intravenous diuretic therapy during 12-48 months follow-up. Secondary endpoints include cardiovascular mortality, recurrent myocardial infarction, stroke, and quality of life. The sample size calculation for the HOT-AAMI trial is based on detecting a relative reduction of 25% in the primary composite endpoint. In the control group, a yearly event rate of 16% is expected, comprised of mortality (7%), hospitalization for heart failure (5%), and acute heart failure requiring outpatient treatment (4%). The study is designed to detect this 25 % relative difference with a two-sided significance level of 0.05 and 80% power, requiring a total of 393 events; therefore 1266 patients will be enrolled.</p><p><strong>Conclusions: </strong>The HOT-AAMI trial is the first trial powered to determine whether SSO2 therapy, administered immediately post-PCI, improves death and heart failure outcomes in patients with anterior STEMI.</p><p><strong>Trial registration: </strong>HOT-AAMI Clinicaltrials.gov NCT06742684.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143690877","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}
Dhruv Sarma, Ryan Smith, Mitchell Padkins, Aniket S Rali, Saraschandra Vallabhajosyula, Ashish K Khanna, Kianoush Kashani, Benjamin Hibbert, Jacob C Jentzer
{"title":"Association between vasopressin administration and mortality in patients with cardiogenic shock.","authors":"Dhruv Sarma, Ryan Smith, Mitchell Padkins, Aniket S Rali, Saraschandra Vallabhajosyula, Ashish K Khanna, Kianoush Kashani, Benjamin Hibbert, Jacob C Jentzer","doi":"10.1016/j.ahj.2025.03.009","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.03.009","url":null,"abstract":"<p><strong>Background: </strong>The utility of vasopressin as an adjunctive, catecholamine-sparing vasopressor in cardiogenic shock (CS) has not been widely examined.</p><p><strong>Methods: </strong>We included consecutive adult patients admitted with a diagnosis of CS requiring vasopressors. High-dose vasopressors (HDV) were defined as ≥0.3 mcg/kg/min of norepinephrine equivalent. Multivariable logistic regression and propensity analysis was used to calculate odds ratio (OR) and 95% confidence interval (CI) values for in-hospital mortality, before and after adjustment for relevant covariates.</p><p><strong>Results: </strong>We included 721 CS patients, including HDV in 32.5%. Vasopressin was administered in 207 (29%) patients within the first 24 hours. In-hospital mortality occurred in 38.1% and was higher in the HDV group (56.8% vs. 29.2%). Vasopressin was associated with lower propensity adjusted in-hospital mortality (adjusted OR 0.59, 95% CI 0.35-0.99, p = 0.05). Vasopressin use was also associated with lower mortality in the HDV group (unadjusted OR 0.54, 95% CI 0.32-0.92, p = 0.02).</p><p><strong>Conclusions: </strong>Vasopressin use in the first 24 hours was associated with lower adjusted mortality in patients with CS, particularly amongst those requiring HDV. The use of vasopressin in CS merits dedicated prospective evaluation.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143690872","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}