Baseline characteristics of patients enrolled in the AZIMUTH trial: an e-health-integrated, smartphone app-based model of care for heart failure patients
Year: 2026
Type: article
Abstract: Aims: The 'FondAZione A. Gemelli IRCCS Artificial Intelligence Empowered Digital PlatforM to sUpport paTients with Heart Failure' (AZIMUTH) study is a multicentre prospective outpatient trial assessing an app-based, e-health-integrated model of care for heart failure (HF) patients. Its primary aim is to evaluate the feasibility and patient/provider acceptance of the app-based intervention, while key secondary aims include assessing its clinical impact through changes in guideline-directed medical therapy (GDMT) prescription/adherence and quality of life. Methods and results: Feasibility is defined as ≥70% of participants maintaining active engagement with the app during follow-up. The platform integrates patient-reported symptoms, connected measurements, medication reminders, and two-way messaging, with clinician review of alerts and trends. Between December 2021 and January 2024, 300 adults with chronic HF, irrespective of left ventricular ejection fraction (LVEF), were enrolled across four Italian centres. Median age was 66 years (IQR 59-73), 78.3% were male, and 82.3% were NYHA Class I-II. LVEF distribution was balanced (HFrEF 35.3%, HFmrEF 25.7%, HFpEF 38.7%). Comorbidities were frequent: hypertension 81.3%, dyslipidaemia 75.7%, ischaemic heart disease 41.0%, diabetes 29.7%, atrial fibrillation 29.7%, and chronic kidney disease 21.7%. At enrolment, RASi/ARNI were prescribed in 69.6%, beta-blockers in 76.9%, MRAs in 16.1%, and SGLT2i in 23.7%. Compared with HFrEF-focused trials, uptake of foundational classes was lower, consistent with the broader LVEF spectrum and real-world constraints. Conclusion: The AZIMUTH cohort represents a contemporary, heterogeneous HF population with variable and suboptimal GDMT uptake. Digital health interventions have the potential to optimize care delivery and increase adherence in real-world settings.
Source: European Heart Journal Open
Authors: Domenico D’Amario, Donato Antonio Paglianiti, Renzo Laborante, Stefano Elia, Gaetano Rizzo, Simona Giubilato, Maria Catalano, Francesco Amico, Maurizio Volterrani, Attilio Restivo, Stefano Patarnello, Sofoklis Kyriazakos, Alice Luraschi, Agni Delvinioti, Federica Tomassini, Konstantina Kostopoulou, Antonio Iaconelli, Enrico Incaminato, Francesco Canonico, Marco Gorini, Stefania Marcoli, Vincenzo Bartoli, Thomas Griffiths, Peter Fenici, Alfredo Cesario, Giuseppe Patti, Filippo Crea
Institutions: Università degli Studi del Piemonte Orientale “Amedeo Avogadro”, Azienda Ospedaliero Universitaria Maggiore della Carita, Karolinska Institutet, Stockholm South General Hospital, Ospedale Cannizzaro, San Raffaele University of Rome, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele, Università Cattolica del Sacro Cuore, Ca' Foncello Hospital, Agostino Gemelli University Polyclinic, Istituti di Ricovero e Cura a Carattere Scientifico
Language: English
Subfield: General Health Professions
Field: Health Professions
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,673
Funder: AstraZeneca Pharma Poland
OpenAlex ID: W7160031229