Heart failure (HF) occurs when the heart is no longer able to pump blood effectively throughout the body. This leads to symptoms that gradually worsen over time and are often mistaken for normal signs of aging. Because of its insidious onset, early detection is challenging. Both patients and healthcare professionals are often insufficiently aware of the early signs and symptoms of HF, resulting in delayed diagnosis. Consequently, timely initiation of treatments that could slow disease progression, improve quality of life, and reduce hospitalizations is often missed. Although a simple blood test measuring NT-proBNP levels can facilitate the early diagnosis of HF, it is not routinely used in clinical practice. The aim of this study is to evaluate whether a combined strategy for the early diagnosis and treatment of HF can reduce hospitalizations. This strategy includes: 1. increasing awareness of HF among patients and physicians, 2. using NT-proBNP testing for the early detection of HF in high-risk patients, and 3. promptly initiating guideline-directed HF treatment when the diagnosis is confirmed. The researchers will assess whether this strategy effectively reduces hospitalizations due to acute heart failure over an 18-month follow-up period.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
18,000
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.
Universitätsklinik für Innere Medizin II
Vienna, Austria
NOT_YET_RECRUITINGQueen Giovanna University Hospital
Sofia, Bulgaria
NOT_YET_RECRUITINGUniversity Hospital Freiburg-Bad Krozingen
Freiburg im Breisgau, Germany
NOT_YET_RECRUITINGUniversitätsklinikum der Ruhr-Universität Bochum
Herne, Germany
NOT_YET_RECRUITINGHerzzentrum Leipzig, Klinik für Innere Medizin/Kardiologie
Leipzig, Germany
NOT_YET_RECRUITINGUniversity Hospital Pisa
Pisa, Italy
NOT_YET_RECRUITINGErasmus MC Rotterdam
Rotterdam, Netherlands
NOT_YET_RECRUITINGKonkuk University Medical Center
Seoul, South Korea
RECRUITINGUniversity Hospital Ramón y Cajal Madrid
Madrid, Spain
NOT_YET_RECRUITINGUniversity Hospital Basel
Basel, Basel, Switzerland
RECRUITING...and 11 more locations
Acute HF event
Time from the index procedure to an acute HF event or follow-up date, together with binary variable indicating the occurrence of an acute Hf event. Acute HF event during index hospitalization is defined as acute HF severe enough to require admission to an intensive/intermediate care unit, non-invasive ventilation, or treatment with at least 40mg furosemide IV.
Time frame: 18 months after intervention
CV death or acute HF event
Time from index hospitalisation to acute HF event, CV death or follow-up date, together with binary variable indicating the occurrence of acute HF event or CV death.
Time frame: 18 months
Hierarchical ordinal composite of CV death, acute HF hospitalization, acute HF during index hospitalization, and no event
Hierarchical ordinal composite of CV death, acute HF hospitalization, acute HF during index hospitalization, and no event (analyzed using the Finkelstein-Schoenfeld win ratio framework. Ties will be resolved according to the predefined event hierarchy. The effect measure will be the win ratio with 95% confidence intervals and two-sided p-values).
Time frame: 18 months
All-cause death
Time from index hospitalisation to hospitalization for acute HF, death, or follow-up date, together with binary variable indicating the occurrence of hospitalization for acute HF or death.
Time frame: 18 months
Cardiovascular death
Time from index hospitalisation to CV death or follow-up date, together with binary variable indicating CV death.
Time frame: 18 months
All-cause hospitalizations
Time from index hospitalisation to hospitalization for acute HF, death, or follow-up date, together with binary variable indicating the occurrence of hospitalization for acute HF or death.
Time frame: 18 months
Changes in medical treatment between the index hospitalisation
Categorical variables indicating changes in specific medical treatments. Changes in medication list (dosage, active pharmaceutical ingredient) during the periods of 1) before index presentation until discharge and 2) after discharge from the index hospitalization up to the 18-month follow-up period measured from the time of the intervention
Time frame: 18 months
Change in kidney function
Standard blood tests obtained during routine clinical care like serum creatinine indicating changes in the kidney function.
Time frame: 18 months
Health economic outcomes: cost of patient management
Cost of patient treatment within 18 months after the index hospitalisation, from different perspectives: hospital real costs perspective, full institutional perspective (considering real costs and reimbursements), healthcare payer perspective.
Time frame: 18 months
Health economic outcome: cost-effectiveness in terms of cost per hospitalization for acute HF avoided
Cost of patient treatment within 18 months after the index hospitalisation and number of hospitalizations for acute HF within 18 months after the index hospitalisation.
Time frame: 18 months
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