AIMS:Atrial fibrillation and flutter (AF) are common in patients with Type 2 diabetes and are associated with worse outcomes. METHODS AND RESULTS:Harmony Outcomes was a multi-centre, event-driven, double-blind, placebo-controlled trial comparing the effects of albiglutide, a glucagon-like peptide-1 receptor agonist, with placebo on a composite of major adverse cardiac events (MACEs; non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death) in 9463 patients aged >40 years with Type 2 diabetes and established cardiovascular disease. Herein, the cardiovascular effects of albiglutide in patients with and without AF, as well as the effects on AF events during follow-up, were analysed. Patients with a history of AF (8.9%) exhibited a higher event rate for the primary composite MACE endpoint during 1.6 years of follow-up {12.7 vs. 6.3 events/100 person-years, adjusted hazard ratio [aHR] 1.41 [95% confidence interval (CI) 1.14-1.74], P = 0.001}. Treatment with albiglutide reduced the occurrence of the primary endpoint irrespective of history of AF at baseline (history of AF: aHR 0.83 [0.58-1.19], no history of AF: aHR 0.77 [0.66-0.90]; Pinteraction = 0.71). During follow-up, 239 patients (2.5%) experienced an AF event. Overall, albiglutide was associated with numerically fewer AF events [108 vs. 131; hazard ratio 0.82 (0.63-1.06), P = 0.12], irrespective of baseline history of AF (Pinteraction = 0.92). CONCLUSION:In patients with Type 2 diabetes, treatment with albiglutide, compared with placebo, reduced the risk of cardiovascular events irrespective of history of AF. Further, albiglutide treatment did not increase AF adverse events but was associated with a trend to a lower rate of AF events during follow-up without reaching statistical significance.

Introduction:It remains unclear whether the US clinical trial ecosystem is optimized to evaluate medical interventions efficiently. This study characterizes interventional clinical trials in the USA and examines trial progress over five years. Methods:Using the Aggregate Analysis of ClinicalTrials.gov (AACT) database, we conducted a cross-sectional study of interventional trials initiated in 2023 and a follow-up cohort tracking five-year completion for trials started in 2018 and registered in ClinicalTrials.gov as of 05/01/2024 by sponsor and therapeutic area. Trials with at least one US site were included. Primary outcomes were enrollment, completion status, intervention type, study arm design, and plan to share individual participant data. Results:Over 7,500 trials met inclusion criteria for each cohort. Most trials started in 2018 (68.4%) and 2023 (62.5%) enrolled fewer than 100 participants. Median enrollment in 2023 was higher for NIH (90) than industry-sponsored (76) trials. Within five years, 60.5% of the 2018 trials were completed, with higher completion among industry (60.9%) than NIH-sponsored (54.3%) trials. In 2023, industry predominantly funded cancer studies and trials testing drug interventions, whereas the NIH prioritized mental health studies and behavioral interventions. More than one-quarter of trials used a single-group design, 72.0% did not plan to share participant-level data, and 72.6% of drug trials were early phase. Conclusion:Many clinical trials are small, lack a control group, and are incomplete within five years, with differences by sponsor. Given the urgent need to improve health through rigorous evidence generation, there are likely opportunities to improve the US clinical trial ecosystem.

Sociodemographic factors influence outcomes in children with congenital heart disease (CHD). We predict an association between measures of social isolation and outcomes in infants with complex CHD. These measures, racial (RI) and educational (EI) isolation range from 0 to 1, with 0 being no isolation and 1 being fully isolated within a specific population. We identified patients less than 1 year old undergoing CHD surgery in North Carolina from 2008 to 2013. We used negative binomial and logistic regression models to assess the case-mix adjusted associations between RI and EI and length of stay, complications, mortality, and resource utilization. We quantified the association of race with these indices and outcomes. We included 1217 infants undergoing CHD surgery. Black infants had increased LOS (p < 0.001), other complications (p = 0.03), and death (p = 0.02). RI up to 0.3 was associated with decreased outpatient encounters (p < 0.001). RI was associated with increased inpatient encounters RI up to 0.3 (p < 0.001) but decreased for RI beyond 0.3 (p = 0.01). There was an association with increased risk of one or more emergency department visits (p = 0.001) at higher levels of EI. Race and RI showed a cumulative effect with children with Black race and greater than median RI having increased LOS (p < 0.001) and fewer outpatient encounters (p = 0.02). RI, EI, and Black race are associated with poorer outcomes. Children with Black race and greater than median levels of RI are at the highest risk of poor outcomes. These differences may be caused by differential access to resources or community support.

Background People with HIV (PWH) have elevated cardiovascular risk. Underrepresented racial and ethnic groups in the southern United States are disproportionately affected, yet whether cardiology care for this at‐risk group improves blood pressure and lipid control or prevents cardiovascular events is unknown. Methods and Results We evaluated a cohort of PWH from underrepresented racial and ethnic groups who received HIV‐related care at 4 centers in the southern United States during 2015 to 2018 with follow‐up through 2020. Primary outcomes were blood pressure control (<140/90 mm Hg) and lipid control (low‐density lipoprotein cholesterol ≤100 mg/dL) over 2 years and time to first major adverse cardiovascular event. Statistical analyses were adjusted for cohort/site and patient sociodemographic factors, HIV measures, and comorbidities. Among 3972 included PWH (median age, 47 years; 32.6% women) without diagnosed cardiovascular disease, 276 (6.9%) had a cardiology clinic visit. Cardiology visits were not associated with subsequent blood pressure control (adjusted odds ratio, 0.78 [95% CI, 0.49–1.24]; P=0.29) or lipid control (adjusted odds ratio, 2.25 [95% CI, 0.72–7.01]; P=0.16). Over 5‐year follow‐up, patients who had a cardiology visit had a higher risk of a major adverse cardiovascular event, death, and falsification end points, even after adjusting for measured risk factors. Conclusions Among PWH from underrepresented racial and ethnic groups at elevated risk for cardiovascular disease, a cardiology clinic visit was not associated with risk factor improvement or reduced risk of a major adverse cardiovascular event. Our study suggests that seeing a cardiologist is not sufficient to promote cardiovascular health or prevent cardiovascular events among PWH, but with low confidence given the higher risk among those who had a cardiology visit.

Adults with congenital heart disease (CHD) benefit from cardiology follow-up at recommended intervals of ≤ 2 years. However, benefit for children is less clear given limited studies and unclear current guidelines. We hypothesize there are identifiable risks for gaps in cardiology follow-up in children with CHD and that gaps in follow-up are associated with differences in healthcare utilization. Our cohort included children < 10 years old with CHD and a healthcare encounter from 2008 to 2013 at one of four North Carolina (NC) hospitals. We assessed associations between cardiology follow-up and demographics, lesion severity, healthcare access, and educational isolation (EI). We compared healthcare utilization based on follow-up. Overall, 60.4% of 6,969 children received cardiology follow-up within 2 years of initial encounter, including 53.1%, 58.1%, and 79.0% of those with valve, shunt, and severe lesions, respectively. Factors associated with gaps in care included increased drive time to a cardiology clinic (Hazard Ratio (HR) 0.92/15-min increase), EI (HR 0.94/0.2-unit increase), lesion severity (HR 0.48 for shunt/valve vs severe), and older age (HR 0.95/month if < 1 year old and 0.94/year if > 1 year old; p < 0.05). Children with a care gap subsequently had more emergency department (ED) visits (Rate Ratio (RR) 1.59) and fewer inpatient encounters and procedures (RR 0.51, 0.35; p < 0.05). We found novel factors associated with gaps in care for cardiology follow-up in children with CHD and altered health care utilization with a gap. Our findings demonstrate a need to mitigate healthcare barriers and generate clear cardiology follow-up guidelines for children with CHD.