Early Detection and IntervenTion in Heart Failure

Heart failure (HF) is a significant global health issue, affecting approximately 64 million individuals worldwide and resulting in over a million hospitalizations annually in Europe and the US. This imposes substantial healthcare costs exceeding $100 billion yearly, with about 70% attributed to acute hospitalizations. The aging population contributes to a rising burden, as HF is often diagnosed late, even in well-funded healthcare settings. Recent insights from studies, including the ongoing BASEL VIII study, challenge the assumption that undetected HF is primarily a failure to detect HF in primary care, revealing a high prevalence of undetected HF even among patients treated by cardiologists. This research initiative revealed that among patients ≥ 65 years, only 3% had known HF, while 29% had undetected HF. Similar observations were also noted in various high-risk settings worldwide, suggesting a surprisingly high rate of undetected HF in clinical practice. Late diagnosis is driven by gradual symptom development, non-specific symptoms often attributed to aging, insensitive clinical signs, and inadequate utilization of B-type natriuretic peptide (BNP) or N-terminal pro-B-type natriuretic peptide (NT-proBNP) testing, the recommended tools for HF diagnosis. The misconception that HF competes with other cardiac diagnoses, rather than complementing them, further contributes to delayed diagnosis. Emerging evidence supports a strategy combining increased awareness, active surveillance using NT-proBNP testing for early HF diagnosis, and prompt treatment with approved evidence-based therapies to reduce HF hospitalizations. However, such intervention bundles are not systematically applied, as no randomized controlled trial (RCT) has ever investigated the efficacy of such structured interventions on hard outcomes. This research initiative aims to assess the effectiveness of an intervention bundle comprising increased awareness, early diagnostics, and early treatment to improve HF prognosis. The study aims to fill critical gaps and evaluate patient-centred outcomes, including hospitalization for acute HF, and health economic implications by using routine clinical data and the standard operating procedures as part of routine clinical practice in the participating sites. By addressing these challenges, the initiative seeks to enhance patient outcomes, reduce the burden on healthcare systems, and contribute to advancing HF care. The bundle intervention, comprising an educational program, guidelines-directed diagnostics, and guidelines-supported management, represents a proactive implementation of best clinical practice. As this proactive approach is not routinely implemented in real-world clinical dynamics, this study primarily focuses on accompanying the implementation of the intervention bundle and contributing valuable data regarding its efficacy. At the same time, the intervention is expected to offer a number of potential benefits for the patients, their health care providers, and the society in general. This will be achieved by a better understanding of the HF problem among patients and medical staff, better adherence to guidelines-supported best clinical practices, and the potential avoidance of hospitalisations due to acute HF.

• CV death or acute HF event [Time frame: 18 months]
• Hierarchical ordinal composite of CV death, acute HF hospitalization, acute HF during index hospitalization, and no event [Time frame: 18 months]
• All-cause death [Time frame: 18 months]
• Cardiovascular death [Time frame: 18 months]
• All-cause hospitalizations [Time frame: 18 months]
• Changes in medical treatment between the index hospitalisation [Time frame: 18 months]
• Change in kidney function [Time frame: 18 months]
• Health economic outcomes: cost of patient management [Time frame: 18 months]
• Health economic outcome: cost-effectiveness in terms of cost per hospitalization for acute HF avoided [Time frame: 18 months]