Tag: nevin manimala

JMIR Public Health Surveill. 2025 Aug 27;11:e77195. doi: 10.2196/77195.

ABSTRACT

BACKGROUND: Ethiopia is faced with poor measles-containing vaccine second dose (MCV2) coverage, leading to recurrent outbreaks.

OBJECTIVE: This meta-analysis and systematic review aimed at combining evidence of MCV2 uptake in Ethiopia and its determinants to inform interventions for increased vaccination uptake and control of public health challenges.

METHODS: This review examined observational quantitative research on measles second dose vaccination among children in Ethiopia using databases such as PubMed Central, Cochrane Library, Web of Science, Scopus, MEDLINE, and Embase. The quality of the included studies was assessed using the Newcastle-Ottawa Scale. Heterogeneity was evaluated using I² statistics and the Cochran Q test, and the analysis used a random-effects model. Publication bias was assessed through funnel plots, the Egger test, and nonparametric trim-and-fill tests.

RESULTS: The overall MCV2 uptake among children aged <5 years in Ethiopia was only 34.4% (95% CI 18.8%-49.9%). Significant determinants of MCV2 uptake included high level of maternal education (adjusted odds ratio [AOR] 3.31, 95% CI 1.32-5.30), attendance to antenatal care follow-ups (AOR 2.02, 95% CI 1.12-2.92), use of postnatal care services (AOR 3.03, 95% CI 1.77-4.28), reduced waiting times at vaccination sites (AOR 2.56, 95% CI 1.98-3.13), good awareness of measles vaccination (AOR 2.17, 95% CI 1.59-2.74), and positive perceptions of the vaccine (AOR 3.58, 95% CI 1.97-6.30).

CONCLUSIONS: This study found that the uptake of MCV2 among children aged <5 years in Ethiopia was 34%, which is far below the global and national goal of 95%. Key factors contributing to low coverage include mothers’ educational levels, use of antenatal and postnatal care services, waiting times at vaccination sites, and mothers’ awareness of the measles vaccine. Improving community-based education programs, increasing access to antenatal and postnatal care services, reducing waiting times, and raising awareness about immunization all contribute to increasing vaccine uptake.

TRIAL REGISTRATION: PROSPERO CRD42024619031; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024619031.

PMID:40864500 | DOI:10.2196/77195

JMIR Res Protoc. 2025 Aug 27;14:e71955. doi: 10.2196/71955.

ABSTRACT

BACKGROUND: Falls and cognitive impairment are major sources of disability in Parkinson disease (PD). The ability to accurately identify individuals with PD at high risk for falls and cognitive impairment would provide an opportunity for intervention and potentially improve long-term outcomes. In a previous study, Assessing Telehealth Outcomes in Multiyear Extensions of Parkinson Disease Trials (AT-HOME PD), we remotely characterized participants with early PD who had participated in 1 of 2 PD clinical trials over 2 years of follow-up. These participants with advancing disease provide a unique opportunity to examine whether the capture of objective in-home measures via digital tools and bothersome symptoms via direct participant report improves the prediction of disease milestones.

OBJECTIVE: Assessing Telehealth Outcomes in Multiyear Extensions of Parkinson Disease Trials-2 (AT-HOME PD2) aims to examine whether digital tools and remote participant reporting can improve the prediction of falls and cognitive impairment, quantify changes in physical activity over time, and explore the relationship between physical activity and clinical progression over time.

METHODS: This is a decentralized observational study of up to 200 individuals with PD, with clinical and digital phenotyping for up to 3 years of follow-up. Participants are those who took part in the STEADY-PD III (NCT02168842), Study of Urate Elevation in Parkinson’s Disease, Phase 3 (SURE-PD3; NCT02642393), AT-HOME PD (NCT03538262), or PD GENEration (NCT04057794) studies. All participants complete 2 video visits per year, wear 2 wrist-worn sensors (Fitbit Charge 5 and ActiGraph CentrePoint Insight Watch) for 1 week each month, complete smartphone-based motor tasks (using the mPower 2.0 app) for 10 days each quarter, and complete online surveys (within the companion Fox Insight study) each quarter. Falls are assessed via a weekly automated telephone call. A cognitive diagnosis is determined by a consensus committee that considers scores on a global cognitive measure, detailed neuropsychological tests, a cognitive-related disability measure, and clinical information. Prediction models will be constructed, and prediction accuracy will be compared across the models.

RESULTS: Recruitment for the study was initiated in September 2023. Enrollment is ongoing, with 142 participants enrolled as of January 2025. Within the cohort, the average age is 69.2 (SD 8.7) years; 85 (59.9%) participants are male, 137 (96.5%) are White, and 2 (1.4%) are Hispanic or Latino; and the average disease duration is 8.9 (SD 1.3) years.

CONCLUSIONS: AT-HOME PD2 is remotely clinically and digitally phenotyping participants with midstage PD to predict falls and cognitive impairment and to provide insights into long-term progression.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/71955.

PMID:40864497 | DOI:10.2196/71955

J Orthop Surg (Hong Kong). 2025 May-Aug;33(2):10225536251374369. doi: 10.1177/10225536251374369. Epub 2025 Aug 27.

ABSTRACT

BackgroundTo compare the effectiveness of VR simulation versus bench-top simulation in the acquisition and transfer of arthroscopic skills among surgical trainees.MethodsA systematic search was conducted across databases including PubMed, Embase, Scopus, and the Cochrane Central Register of Controlled Trials to identify randomized controlled trials (RCTs) comparing VR and bench-top simulation training for arthroscopy. Studies involving surgical novices, such as medical students and residents with minimal prior arthroscopic experience, were included. Data extracted encompassed study design, participant demographics, intervention details, and outcome measures related to skill acquisition and transfer. The primary outcomes assessed were improvements in arthroscopic skills, procedural efficiency, and task accuracy. Secondary outcomes included skill transferability to cadaveric or live surgical settings, skill retention over time, and participant confidence levels. A random-effects model was utilized for meta-analysis, with standardized mean differences (SMD) and 95% confidence intervals (CI) calculated for continuous variables. Heterogeneity was assessed using the I² statistic.ResultsBoth VR and bench-top simulation training resulted in significant improvements in arthroscopic skills compared to baseline measurements. However, the VR simulation group consistently outperformed the bench-top model group in diagnostic arthroscopy crossover tests and in simulated cadaveric setups. Furthermore, the VR group demonstrated superior skill transfer in surprise skill transfer tasks. These findings suggest that while both simulation modalities are effective for arthroscopic skill acquisition, VR simulation may offer advantages in terms of skill transferability and overall performance enhancement.ConclusionsBoth VR and bench-top simulation trainings are effective in enhancing arthroscopic skills among surgical trainees. However, VR simulation demonstrates superior outcomes in skill acquisition and transferability to real-world surgical settings.

PMID:40864496 | DOI:10.1177/10225536251374369

G Ital Cardiol (Rome). 2025 Sep;26(9):687-697. doi: 10.1714/4542.45433.

ABSTRACT

BACKGROUND: Heart failure (HF) significantly impacts on morbidity, mortality, and healthcare use, particularly in elderly populations and underserved areas. Remote monitoring can anticipate clinical deterioration and improve care. The aim of this study was to describe the ASL Nuoro’s integrated model for proactive HF management via telemonitoring.

METHODS: A prospective observational study enrolled HF patients stratified by the 3C-HF score and monitored using non-invasive home devices linked to the CARE MAP platform.

RESULTS: From April 2023 to March 2025, 499 patients were enrolled; 354 were active at follow-up (mean age 80 ± 11 years, 61% men). Therapeutic adherence was high (sodium-glucose cotransporter 2 inhibitors 85%, angiotensin receptor-neprilysin inhibitors 56%). Monthly clinical alerts averaged 1740 (60% clinical relevant), leading to 413 contacts/month. HF hospitalizations dropped by 71% (June-December 2023 vs. 2022).

CONCLUSIONS: The integrated model proves to be feasible, effective, and sustainable, even in settings characterized by high organizational complexity. From a social perspective, it ensures equitable access to care and is applicable in geographically disadvantaged areas. The inherent limitations of the 3C-HF score highlight the need for more advanced and dynamic prognostic tools. The intervention also demonstrates economic advantage through the reduction of hospitalizations and the optimization of resource utilization.

PMID:40864487 | DOI:10.1714/4542.45433

JAMA Netw Open. 2025 Aug 1;8(8):e2528933. doi: 10.1001/jamanetworkopen.2025.28933.

ABSTRACT

IMPORTANCE: Advanced diabetes technologies such as continuous glucose monitoring (CGM), continuous subcutaneous insulin infusion (insulin pumps [CSII]), and glucometers alongside insulin access represent the criterion standard for managing type 1 diabetes (T1D) in children. Global disparities in their access and reimbursement may be associated with glycemic outcomes.

OBJECTIVE: To describe how accessibility and reimbursement of advanced diabetes technologies and insulin are associated with glycated hemoglobin (HbA1c) levels in centers participating in the SWEET initiative, an international pediatric diabetes registry.

DESIGN, SETTING, AND PARTICIPANTS: This global multicenter cross-sectional study collected data from 81 centers in 56 countries. Web-based questionnaires were distributed to representatives of all 121 pediatric diabetes centers participating in the SWEET initiative from March 1 to May 31, 2024, and used to map accessibility of and reimbursement for CGM, CSII, glucometers, and insulin. Reimbursement data were compared with HbA1c levels using the SWEET Study dataset. Participants included 42 349 children with T1D.

EXPOSURES: Responses were categorized into 4 groups based on the extent of reimbursement for diabetes technologies and insulin.

MAIN OUTCOMES AND MEASURES: Mean HbA1c levels across centers calculated from measurements current as of December 31, 2023, analyzed by categories of accessibility of and reimbursement for diabetes technologies and insulin.

RESULTS: Data collected from 81 of 121 SWEET centers (67%) across 56 countries included HbA1c levels from 42 349 children with T1D (22 021 male [52%]; mean [SD] age, 14.3 [4.4] years; mean [SD] diabetes duration, 6.0 [4.2] years). Universal access with complete reimbursement for all technologies and insulin was reported by 32 centers from 19 countries, while 8 countries reported no reimbursement for any technologies or insulin. Centers with full reimbursement for CSII, CGM, glucometers, and insulin showed mean HbA1c levels of 7.62% (95% CI, 7.59%-7.64%) to 7.75% (95% CI, 7.73%-7.77%) compared with 9.65% (95% CI, 9.55%-9.71%) to 10.49% (95% CI, 10.40%-10.58%) in centers with no reimbursement and/or no availability (P < .001 for all items).

CONCLUSIONS AND RELEVANCE: This cross-sectional study found that HbA1c levels were associated with the accessibility of modern diabetes technologies and insulin. Efforts to ensure universal accessibility are required to reduce global inequities and glycemic outcomes for children with T1D.

PMID:40864470 | DOI:10.1001/jamanetworkopen.2025.28933

JAMA Netw Open. 2025 Aug 1;8(8):e2529026. doi: 10.1001/jamanetworkopen.2025.29026.

ABSTRACT

IMPORTANCE: Starting in 2014, US guidelines have not recommended β-blockers for first-line treatment of hypertension in the absence of compelling indications due to their tolerability profile and inferior protection against stroke and mortality compared with other first-line agents. The prevalence and factors associated with this guideline-discordant practice are unknown.

OBJECTIVE: To estimate the prevalence of and factors associated with first-line β-blocker use among those without compelling indications for a β-blocker.

DESIGN, SETTING, AND PARTICIPANTS: Serial cross-sectional study of new users of antihypertensive medications using national, patient-level data in the Veterans Health Administration between January 1, 2000, and December 31, 2022. Patients were veterans initiating antihypertensive medications for newly diagnosed hypertension in the outpatient setting based on diagnosis codes and prescription dispenses, excluding veterans without a primary care visit in the prior year.

EXPOSURE: Initiation of antihypertensive medications for newly diagnosed hypertension.

MAIN OUTCOMES AND MEASURES: Among those without compelling indications (ie, aortic aneurysm and/or disease, angina, atrial fibrillation or arrhythmia, chronic liver disease or cirrhosis, heart failure with reduced ejection fraction, myocardial infarction, or coronary revascularization), multivariable Poisson regression was used to estimate factors associated with β-blocker initiation.

RESULTS: Of 3 138 304 included veterans (mean [SD] age 61.0 [13.0] years, 2 958 488 [94.3%] male, 149 807 [4.8%] Hispanic, 490 636 [15.6%] non-Hispanic Black, 2 028 127 [64.6%] non-Hispanic White, and and 66 798 [2.1%] other races and ethnicities ), 774 821 (24.7%) initiated a β-blocker. Overall, 684 045 patients (88.2%) who initiated a β-blocker did not have compelling indications, which decreased over time from 245 703 (91.8%) in 2000 through 2005 to 93 088 (81.5%) in 2018 to 2022. Metoprolol and carvedilol were the most commonly initiated β-blockers and increased over time, and atenolol initiation decreased over time. Among other factors, a greater prevalence ratio for β-blocker initiation was observed among older (PR, 1.05; 95% CI, 1.04-1.05), female (PR, 1.11; 95% CI, 1.09-1.14), non-Hispanic White (as reference group; Non-Hispanic Black PR, 0.74; 95% CI, 0.73-0.76; Hispanic PR, 0.75; 95% CI, 0.73-0.77; all others PR, 0.89; 95% CI, 0.86-0.92) or frail veterans (PR, 1.28; 95% CI, 1.25-1.31).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study, most veterans using β-blockers as a first-line treatment for hypertension did not have compelling indications, and several factors were associated with likelihood of β-blocker initiation in this group. Interventions are needed to improve initial guideline-concordant treatment for veterans with incident hypertension.

PMID:40864469 | DOI:10.1001/jamanetworkopen.2025.29026

JAMA Netw Open. 2025 Aug 1;8(8):e2529148. doi: 10.1001/jamanetworkopen.2025.29148.

ABSTRACT

IMPORTANCE: Evidence supporting the safety of infusing vasopressors through peripheral intravenous catheters (peripheral vasopressors) is largely derived from single-center studies, limiting generalizability.

OBJECTIVE: To evaluate factors associated with vasopressor route selection and assess safety and clinical outcomes of peripheral vasopressor administration in early sepsis resuscitation.

DESIGN, SETTING, AND PARTICIPANTS: This prospective cohort study is a secondary analysis of the Crystalloid Liberal vs Early Vasopressors in Sepsis (CLOVERS) trial conducted in 60 US hospitals from March 2018 to February 2022. Patients in CLOVERS who received vasopressors within 24 hours of enrollment and did not have central venous access at enrollment were included. Data were analyzed from January 2023 to June 2025.

EXPOSURE: Route of vasopressor initiation (central or peripheral).

MAIN OUTCOMES AND MEASURES: The primary analysis evaluated the route of vasopressor initiation, while the secondary analysis assessed continuation of peripheral vasopressors beyond 6 hours. Univariable and multivariable analyses of factors associated with vasopressor route were conducted, as was a multivariable analysis to evaluate the association of route with outcomes, including 90-day mortality. Descriptive statistics were used to summarize 28-day peripheral vasopressor and central venous catheter (CVC) complications.

RESULTS: Of 1563 patients in CLOVERS, 582 (37.2%) received vasopressors and met study inclusion criteria. Included patients had a median (IQR) age of 63 (52-72) years, and 267 (45.9%) were female, 96 (16.5%) were African American, 416 (71.5%) were White, and 70 (12.0%) were another race or had unreported race. Vasopressors were initiated via peripheral catheter in 490 patients (84.2%) and via central venous access in 92 patients (15.8%). Study site was the only factor independently associated with route of initiation (median odds ratio, 3.48; 95% CI, 1.57-5.38). In adjusted analyses, peripheral vs central initiation was associated with statistically comparable 90-day mortality (128 participants [26.1%] vs 34 participants [37.0%]; adjusted odds ratio, 0.67; 95% CI, 0.39-1.16). Peripheral vasopressors were continued beyond 6 hours in 333 of 490 patients (68.0%). Peripheral vasopressor complications were rare and low-grade (3 of 490 patients [0.6%]), with no cases of ulceration or tissue injury. In contrast, there were 14 complications from CVC placement occurring in 12 of 322 patients (3.7%) who had CVCs placed in the first 72 hours.

CONCLUSIONS AND RELEVANCE: In this prospective cohort study of the CLOVERS trial, peripheral administration of vasopressors was common and was associated with low complication rates. These findings support the safety and feasibility of short-term peripheral vasopressor use in early sepsis resuscitation.

PMID:40864467 | DOI:10.1001/jamanetworkopen.2025.29148

JAMA Netw Open. 2025 Aug 1;8(8):e2529409. doi: 10.1001/jamanetworkopen.2025.29409.

ABSTRACT

IMPORTANCE: India’s goal of measles elimination remains unmet, as evidenced by significant recent outbreaks.

OBJECTIVE: To identify seroprevalence rates among vaccinated children and to examine demographic factors that influence antibody responses.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study included a highly vaccinated cohort of Indian children from the states of Kerala and Tamil Nadu between 2018 and 2023. Eligible children had received at least 2 doses of measles-containing vaccines; their mothers were recruited from various community settings, including local nursery and secondary schools, residential associations, and hospitals.

EXPOSURE: Measles-specific antibodies were quantified in serum samples.

MAIN OUTCOMES AND MEASURES: Measles-specific immunoglobulin G (IgG) and neutralizing antibodies were quantified in both children and mothers. Measles-specific IgM was also measured in children.

RESULTS: The total cohort comprised 684 children (median age, 9 years [range, 4-18 years]; 348 male [50.1%]) and 544 mothers. All children received at least 2 doses of measles-containing vaccines; 435 children (63.6%) received a third dose, and 7 (1.0%) received a fourth dose. Among the children, 621 (90.8%) had positive measles-specific IgG, and 623 (91.5%) had protective neutralizing antibodies titers, with a strong correlation between measles-specific IgG and neutralizing antibodies (r = 0.73; P < .001). Female children exhibited significantly higher titers of both measles-specific IgG and neutralizing antibodies compared with male children. While IgG and neutralizing antibody titers remained stable over time and were not associated with the number of vaccine doses in children, neutralizing antibody titers increased with age in mothers, likely due to repeated viral exposure. Notably, in 20 families with at least 2 children, differential measles-specific IgM profiles were observed between siblings despite high IgG and neutralizing antibody titers, suggesting ongoing breakthrough infections.

CONCLUSIONS AND RELEVANCE: In this cross-sectional study, substantial measles immunity gaps were found despite high vaccine coverage with evidence of breakthrough infections, posing significant challenges to India’s measles elimination efforts. These results underscore the urgent need to strengthen India’s immunization program and investigate the mechanisms driving suboptimal responses to measles vaccination; without addressing these immune response deficiencies, achieving measles elimination through increased vaccine coverage alone may remain unattainable in India.

PMID:40864465 | DOI:10.1001/jamanetworkopen.2025.29409

JAMA Surg. 2025 Aug 27. doi: 10.1001/jamasurg.2025.3089. Online ahead of print.

ABSTRACT

IMPORTANCE: Although randomized and well-controlled observational studies demonstrate the efficacy of glucagon-like peptide-1 receptor agonists (GLP-1s) for weight management after bariatric surgery, little is known regarding the frequency and predictors of such use.

OBJECTIVE: To characterize the use of and factors associated with GLP-1 initiation among US adults undergoing bariatric surgery.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study was conducted using a national multicenter database of electronic health records of approximately 113 million US adults. Adults undergoing bariatric surgery from January 2015 to May 2023 who did not use GLP-1s during the 12 months prior to surgery were eligible for inclusion. Data were analyzed from October 2024 to May 2025.

EXPOSURES: Sociodemographic factors (age, sex, race, region, etc) and clinical factors (bariatric surgery procedures, body mass index [BMI, calculated as weight in kilograms divided by height in meters squared], comorbidities, comedications).

MAIN OUTCOMES AND MEASURES: The primary outcome was GLP-1 initiation after bariatric surgery, first characterized using descriptive statistics. Cox proportional hazards models were then used to identify baseline patient characteristics associated with GLP-1 initiation. Time-dependent Cox models were also used to examine the association of postsurgery BMI with GLP-1 initiation.

RESULTS: Among 112 858 individuals undergoing bariatric surgery, mean (SD) age was 45.2 (12.9) years, and 88 994 individuals (78.9%) were female. By self-reported race, 1210 individuals (1.1%) were Asian, 24 941 (22.1%) were Black or African American, 72 423 (64.2%) were White, and 14 284 (12.6%) reported other race (American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, or unknown). A total of 15 749 individuals (14.0%) initiated GLP-1s after surgery, with 3391 (21.5%) beginning within 2 years of surgery and the remainder initiating during postsurgical years 3 to 4 (5082 [32.3%]), years 5 to 6 (3964 [25.2%]), or beyond (3312 [21.0%]). The overall median (IQR) BMI before GLP-1 initiation was 42.0 (38.3-45.6). In regression models, female patients (adjusted hazard ratio [aHR], 1.61; 95% CI, 1.54-1.69), those undergoing sleeve gastrectomy (aHR, 1.42; 95% CI, 1.37-1.47), and those with type 2 diabetes (aHR, 1.34; 95% CI, 1.28-1.39) were more likely to initiate GLP-1s than their counterparts. Each 1-unit increase in postsurgical BMI was associated with an 8% increase in likelihood of GLP-1 initiation (aHR, 1.08; 95% CI, 1.08-1.08).

CONCLUSIONS AND RELEVANCE: In this retrospective cohort study using a nationwide database, among a cohort of US adults undergoing bariatric surgery, approximately 1 in 10 initiated a GLP-1. Initiation was greater among women, those undergoing sleeve gastrectomy, and individuals with larger BMI regain than among their counterparts.

PMID:40864458 | DOI:10.1001/jamasurg.2025.3089

JAMA Cardiol. 2025 Aug 27. doi: 10.1001/jamacardio.2025.2827. Online ahead of print.

ABSTRACT

IMPORTANCE: Patients with heart failure with preserved ejection fraction (HFpEF) and physiologic pacemakers may benefit from pacing rates above the standard 60 beats per minute (bpm).

OBJECTIVE: To compare adverse event accrual between personalized accelerated pacing and usual care in HFpEF.

DESIGN, SETTING, AND PARTICIPANTS: This was an observational extension of the myPACE randomized clinical trial with up to 4 years of follow-up in 100 patients with stage B or C HFpEF and preexisting physiologic pacemakers treated at the University of Vermont Medical Center. The myPACE study was conducted from June 2019 to December 2021; follow-up for this report was concluded in June 2023.

INTERVENTION: Participants in the original myPACE trial were randomly assigned to either personalized accelerated pacing (myPACE) or 60 bpm (usual care).

MAIN OUTCOMES AND MEASURES: The primary outcome was the accrual of first and recurrent adverse clinical events during the open-label follow-up phase-including urgent visits or hospitalizations for heart failure or atrial fibrillation, myocardial infarction, stroke, or death-assessed using an intention-to-treat (ITT) analysis and a prespecified per-protocol (PP) analysis of patients who continued their assigned treatment. Secondary outcomes included event-free survival in both ITT and PP analyses.

RESULTS: Among the 100 original trial participants (48 in myPACE and 52 in usual care), the ITT analysis demonstrated a trend toward slower event accrual with the myPACE intervention (15 vs 33 events; Lin-Wei-Ying-Yang estimate [LWYY], 0.48; 95% CI, 0.22-1.06; P = .07) and longer event-free survival (hazard ratio [HR], 0.63; 95% CI, 0.31-1.29; P = .20) but did not reach statistical significance. In the prespecified PP analysis, 87 remained on their assigned heart rate setting over the 4-year follow-up (39 in myPACE and 48 in usual care). The mean (SD) age was 74 (10) years, and 48 participants (55%) were male. In this PP analysis, myPACE was associated with a slower accrual of clinical events (5 vs 31 events; LWYY, 0.16; 95% CI, 0.04-0.67; P = .01) and longer event-free survival (HR, 0.30; 95% CI, 0.11-0.80; P = .02) compared to usual care. These results were primarily driven by heart failure-related events.

CONCLUSIONS AND RELEVANCE: In this observational clinical events analysis of the myPACE trial, analysis by ITT did not achieve statistical significance between study arms. However, PP analysis showed that personalized accelerated physiologic pacing was associated with a slower accrual of adverse clinical events compared with the standard 60-bpm setting. These results are hypothesis generating and warrant confirmation in larger multicenter trials.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04721314.

PMID:40864451 | DOI:10.1001/jamacardio.2025.2827