The paper highlighted how the platform addressed the fragmented nature of heart failure care by enabling continuous communication between hospital specialists and community healthcare providers.

Study Design and Implementation

The AZIMUTH study (FondAZione A. Gemelli IRCCS Artificial Intelligence Empowered Digital PlatforM to sUpport paTients with Heart Failure) addressed this healthcare challenge through innovative digital health technology. It demonstrates how smartphone-based care could transform outcomes for heart failure patients. This multicenter, prospective study enrolled 300 heart failure patients across four leading Italian medical centers in Phases 1 and 2.

The study utilized Healthentia v3, a Class I Software as Medical Device (SaMD), as the core platform for remote patient monitoring and care delivery operating through two integrated components:

Patient Mobile Application: Patients used intuitive “widgets” for daily health monitoring, including mandatory weight and blood pressure tracking, validated questionnaires (Kansas Questionnaire and medication adherence assessments), and optional monitoring of heart rate, oxygen saturation, and physical activity. The app seamlessly integrated with Bluetooth-enabled devices to minimize manual entry errors.

Clinical Dashboard: Healthcare providers accessed a platform that consolidated patient data into actionable insights, featuring real-time monitoring, intelligent alert systems based on clinical thresholds, longitudinal trend analysis, and integrated patient communication tools.

The study carefully addressed the real-world implementation by establishing clear inclusion criteria that balanced technological requirements with practical applicability. Patients required basic digital literacy or caregiver support, smartphone compatibility, and received comprehensive training during enrollment. The platform was designed for intuitive use across age groups, ensuring broad accessibility.

Proven Results

The study successfully demonstrated the effectiveness of digital health solutions in heart failure management:

Patient Engagement: Achieved the primary objective with over 70% of patients successfully engaging with the digital platform throughout the study period.

Clinical Improvements: Patients showed significantly improved medication adherence and treatment engagement compared to traditional care approaches.

Healthcare Provider Value: Clinicians reported enhanced ability to monitor patients remotely, identify early warning signs, and coordinate care more effectively.

Feasibility Confirmed: The app-based model proved both technically feasible and clinically valuable across diverse patient demographics.

Impact and Validation

AZIMUTH validated that smartphone-based care could transform outcomes for heart failure patients – a population traditionally challenged by frequent hospitalizations and complex medication regimens. The study proved that digital health solutions, when properly implemented through certified medical device platforms like Healthentia, could enhance both patient outcomes and healthcare efficiency.

The successful completion of AZIMUTH Phase 1 established a new evidence base for digital health adoption in chronic disease management. Azimuth demonstrated that collaborative innovation between healthcare institutions, pharmaceutical companies, and technology providers can deliver measurable clinical value. A second paper with results from Phase II is expected soon and new partners have joined efforts in a new study named Azimusa utilizing the Azimuth care model and expanding further the scope to more medical centers in the north with more patients.

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CATEGORY: Digital Health

SOURCE: European Heart Journal – Digital Health, April 2025, https://doi.org/10.1093/ehjdh/ztaf040

Study design and rationale of the AZIMUTH trial: a smartphone, app-based, E-health-integrated model of care for heart failure patients

Domenico D’Amario¹, Attilio Restivo^2,3, Renzo Laborante^2,3, Donato Antonio Paglianiti^2,3, Alfredo Cesario^2,3,4,5, Stefano Patarnello², Sofoklis Kyriazakos⁶, Alice Luraschi², Konstantina Kostopoulou⁶, Antonio Iaconelli^2,3, Enrico Incaminato¹, Gaetano Rizzo¹, Marco Gorini⁷, Stefania Marcoli⁷, Vincenzo Bartoli⁷, Thomas Griffiths⁸, Peter Fenici^3,7,9, Simona Giubilato¹⁰, Maurizio Volterrani¹¹, Giuseppe Patti¹, Vincenzo Valentini^2,3, Giovanni Scambia^2,3, Filippo Crea^3,12

More Publications

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CATEGORY: eHealth, Health monitoring, e-Health applications, Cardiovascular diseases, Virtual Assistant, Remote patient monitoring
SOURCE: Int. J. Environ. Res. Public Health 2023, FEB. 22, 20(5), 3937; https://doi.org/10.3390/ijerph20053937;

Assessing the Efficacy of a Virtual Assistant in the Remote Cardiac Rehabilitation of Heart Failure and Ischemic Heart Disease Patients: Case-Control Study of Romanian Adult Patients

Andreea Lăcraru, Ștefan-Sebastian Busnatu, Maria-Alexandra Pană, Gabriel Olteanu, Liviu Șerbănoiu, Kai Gand, Hannes Schlieter, Sofoklis Kyriazakos, Octavian Ceban, Cătălina Liliana Andrei & Crina-Julieta Sinescu

Abstract

Cardiovascular diseases (CVDs) are the leading cause of mortality in Europe, with potentially more than 60 million deaths per year, with an age-standardized rate of morbidity-mortality higher in men than women, exceeding deaths from cancer. Heart attacks and strokes account for more than four out of every five CVD fatalities globally. After a patient overcomes an acute cardiovascular event, they are referred for rehabilitation to help them to restore most of their normal cardiac functions. One effective way to provide this activity regimen is via virtual models or telerehabilitation, where the patient can avail themselves of the rehabilitation services from the comfort of their homes at designated timings. Under the funding of the European Union’s Horizon 2020 Research and Innovation program, grant no 769807, a virtual rehabilitation assistant has been designed for elderly patients (vCare), with the overall objective of supporting recovery and an active life at home, enhancing patients’ quality of life, lowering disease-specific risk factors, and ensuring better adherence to a home rehabilitation program. In the vCare project, the Carol Davila University of Bucharest (UMFCD) was in charge of the heart failure (HF) and ischemic heart disease (IHD) groups of patients. By creating a digital environment at patients’ homes, the vCare system’s effectiveness, use, and feasibility was evaluated. A total of 30 heart failure patients and 20 ischemic heart disease patients were included in the study. Despite the COVID-19 restrictions and a few technical difficulties, HF and IHD patients who performed cardiac rehabilitation using the vCare system had similar results compared to the ambulatory group, and better results compared to the control group.

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Study Description

AZIMUTH model of care is delivered through Healthentia; a Software as a Service (SaaS) medical device via a mobile application for patients and a clinical dashboard for clinicians for Remote Patient Monitoring (RPM), Patient Support Programs (PSP) and Digital Therapeutics (DTx). This innovative scalable model of personalised remote heart failure care is based on good clinical practice standards and international guidelines for heart failure management and has been designed taking into consideration both the optimization of in-hospital care delivery models as well as the often unmonitored out-of-hospital and home settings

The first phase of the study has successfully validated the feasibility, patient acceptance and perceived value of the app-based model of care, demonstrating increased user engagement in patients that leads into improved adherence to treatment.

Dr. Domenico D’Amario

Senior Cardiologist at the Gemelli IRCCS Polyclinic Foundation

Study Details

• Type:  Interventional
• Disease:  Heart Failure – Chronic Ischemic Disease
• Sites: Fondazione Policlinico Gemelli
• Start:  Phase 1: Nov-March 2021, Phase 2: Jul-Jan 2023
• Population: 300 patients
• Duration: Multiphase project

Study Design & Method

Heart failure is the leading cause of death and hospitalisation in patients aged > 65 years and a major and growing medical and economic burden, with high prevalence and incidence rates worldwide. The recent pandemic crisis has made even more evident, some critical aspects in the management of complex chronic diseases, such as heart failure, and these could be exacerbated by the increased demand for care in the future. Therefore, a significant effort must be made to align services with patients’ care needs by identifying a shared model that can exploit the most advanced technologies to enhance disease deterioration, provide adequate integration between hospital and territorial services, increase appropriateness, and reduce waiting times for specialist services.

Testimonial

The care pathway for patients with heart failure includes several steps, from acute phase treatments to chronic phase patient follow-up. This requires a close dialogue between hospital cardiologists and community medicine, especially once the patient returns home, after being discharged from a third-level hospital. But at the moment this complex path is very fragmented.

Validated the feasibility, patient acceptance and perceived value of remote patient monitoring

Demonstrating increased user engagement in patients that leads into improved adherence to treatment

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