The 11th Cardiovascular Outcome Trial (CVOT) Summit: Congress on Cardiovascular, Kidney, and Metabolic Outcomes was held virtually on November 20-21, 2025. The Summit provided a multidisciplinary forum to review and discuss recent outcome trials investigating emerging pharmacological therapies targeting diseases of the cardiovascular-kidney-metabolic (CKM) continuum. This report highlights the unique developments of 2025 discussed during the Summit, including the first head-to-head CVOT (SURPASS-CVOT), the growing evidence base for combination therapies across the disease spectrum, new insights into the inflammatory component of the CKM syndrome, and relevant policy developments. The first part of this report summarizes pioneering clinical trials addressing combination therapy with finerenone and empagliflozin (CONFIDENCE), the oral glucagon-like peptide-1 (GLP-1) receptor agonists orforglipron (ATTAIN-1), and the aldosterone synthase inhibitor (ASI) baxdrostat (BaxHTN). The second part presents recent guideline and policy developments discussed by experts in endocrinology, diabetology, cardiology, nephrology, hepatology, and general practice. In addition, advances in medical technology, particularly in continuous glucose and ketone monitoring, are highlighted, as well as emerging therapies for diseases of the CKM continuum. These include pharmacological agents for a broad spectrum of metabolic disorders such as metabolic liver disease and type 1 Diabetes (T1D) alongside emphasis on the importance of early detection and innovative treatment strategies. The 12th Cardiovascular Outcome Trial Summit will be held virtually on 19-20 November 2026 (http://www.cvot.org).
With the rising number of innovative artificial intelligence (AI) developments claiming to be "ready for clinical use", we see an urgent need for an AI governance and ethics policy that supports the introduction of AI systems within university hospitals. To gain a comprehensive overview, we interviewed professionals from various disciplines within the hospital environment who may be involved in AI applications, including physicians, data protection officers, legal department personnel, and IT specialists. Based on this, we developed a governance and ethics policy for the introduction of AI systems in university hospitals. We conducted six group discussions (focus groups) at four German university hospitals. The results were analyzed and subsequently converted into an AI governance and ethics policy. A preliminary version of a generic AI governance and ethics policy for the introduction of AI systems within university hospitals was developed. Based on this, an AI introduction guideline and checklist were established at the University Hospital Erlangen (UKER) as a first use case. The developed AI governance and ethics policy was actively piloted at the UKER aiming to carry out the introduction of AI systems in German university hospitals in a structured manner and to establish a systematic process to mitigate potential risks. The policy is an initial step towards the development of a holistic AI governance and ethics framework and enables hospital administrators to systematically evaluate AI systems that are requested to be implemented by using standardized criteria aligning with the key requirements of the European Union (EU) AI Act. So far, 44 AI-system inquiries have been processed and evaluated based on the developed AI governance and ethics policy. The roll-out of the policy across additional German university hospitals is ongoing as part of the multicenter project Open Medical Inference (OMI) within the Medical Informatic Initiative Germany (MII).
Abstract Purpose The aim of this study was to investigate the impact of post-exertional malaise (PEM) frequency and PEM severity on health-related quality of life (HRQoL) among individuals with Long COVID. Methods We conducted a cross-sectional online survey including adults in Germany with self-reported Long COVID and PEM. Fatigue severity was assessed with the Fatigue Assessment Scale (FAS), and HRQoL was measured using the EQ-5D-3L (descriptive index and visual analogue scale [EQ-VAS]). Associations between PEM frequency, fatigue, and HRQoL were examined using correlations and non-parametric group comparisons. Multiple linear regression models were fitted to predict HRQoL while controlling for age, sex, employment status, and subjective social status. Results Higher PEM frequency was associated with significantly lower EQ-5D index scores (ρ = − 0.32, p<.001). PEM severity was also strongly correlated with reduced HRQoL (EQ-5D index: ρ = − 0.43, p<.001). In multivariable regression models, greater fatigue and higher PEM frequency independently predicted poorer HRQoL, even after adjustment for sociodemographic factors. Conclusion Both PEM frequency and PEM severity substantially impair HRQoL in individuals with Long COVID. These findings underscore the clinical relevance of PEM as a key symptom and highlight the need for targeted management strategies to mitigate its impact on daily life. Clinical trial number German Clinical Trials Register DRKS00026007; registration date: 9 September 2021.
Ketogenic diet therapy (KDT) is an evidence-based treatment for refractory epilepsy, particularly in children. Strict adherence to carbohydrate restriction is essential to maintain ketosis, yet many medications contain excipients that can disrupt this balance. Pharmacists play a crucial role in evaluating and adjusting medication regimens for patients on KDT, but limited transparency regarding excipient content often makes this process inefficient and inconsistent. Although some regional databases exist, no systematic and comprehensive resources have been developed for broader use. This study aimed to systematically classify pharmaceutical excipients and label all medications marketed in the Netherlands according to their compatibility with KDT (“Ketoproof” status) using a transparent, reproducible framework that can serve as the foundation for safer prescribing and international standardization. A retrospective cross-sectional database analysis was conducted using data from the Dutch G-Standaard (June 2023–March 2024), a national pharmaceutical reference database used in the Netherlands. All excipients authorized in medications marketed in the Netherlands were extracted and classified based on chemical composition, metabolic fate, and administration route. Excipients were assigned a Ketoproof status through a structured decision flowchart, expert consensus, and quality control review. Finally, pharmaceutical products were labeled by cross-referencing their excipient profiles against the classified dataset. A total of 1047 excipients were identified. Of these, 778 (74
BACKGROUND:Catheter-based closure of the left atrial appendage is an alternative to oral anticoagulation for stroke prevention in patients with atrial fibrillation. The effectiveness of this strategy, as compared with physician-directed best medical care, in patients at high risk for stroke and bleeding is unknown. METHODS:In this multicenter randomized trial conducted in Germany, we assigned patients with atrial fibrillation and a high risk of stroke and bleeding to undergo left atrial appendage closure or to receive physician-directed best medical care (including direct oral anticoagulants, if eligible). The primary end point, tested for noninferiority, was a composite of stroke (ischemic or hemorrhagic), systemic embolism, major bleeding, or cardiovascular or unexplained death, assessed in a time-to-event analysis. The noninferiority margin was a hazard ratio of 1.3. RESULTS:A total of 912 adult patients underwent randomization. The primary end-point analysis included 446 patients who were assigned to undergo left atrial appendage closure (device group) and 442 who were assigned to physician-directed best medical care (medical-therapy group). The mean (±SD) age was 77.9±7.1 years; 38.6% of the patients were women, the mean CHA2DS2-VASc score was 5.2±1.5 (range, 0 to 9, with higher scores indicating a greater risk of stroke), and the mean HAS-BLED score was 3.0±0.9 (range, 0 to 9, with higher scores indicating higher risk of bleeding). After a median follow-up of 3 years (interquartile range, 1.7 to 4.7), a first primary end-point event had occurred in 155 patients (incidence per 100 patient-years, 16.8) in the device group and in 127 patients (incidence per 100 patient-years, 13.3) in the medical-therapy group (difference in restricted mean survival time, -0.36 years; 95% confidence interval, -0.70 to -0.01; P = 0.44 for noninferiority). Serious adverse events occurred in 368 patients (82.5%) in the device group and 342 (77.4%) in the medical-therapy group. CONCLUSIONS:Among patients with atrial fibrillation at high risk for stroke and bleeding, left atrial appendage closure was not noninferior to physician-directed best medical care with regard to a composite end point of stroke, systemic embolism, major bleeding, or cardiovascular or unexplained death. (Funded by the German Center for Cardiovascular Research; CLOSURE-AF ClinicalTrials.gov number, NCT03463317.).
