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 Restivo2,3, Renzo Laborante2,3, Donato Antonio Paglianiti2,3, Alfredo Cesario2,3,4,5, Stefano Patarnello2, Sofoklis Kyriazakos6, Alice Luraschi2, Konstantina Kostopoulou6, Antonio Iaconelli2,3, Enrico Incaminato1, Gaetano Rizzo1, Marco Gorini7, Stefania Marcoli7, Vincenzo Bartoli7, Thomas Griffiths8, Peter Fenici3,7,9, Simona Giubilato10, Maurizio Volterrani11, Giuseppe Patti1, Vincenzo Valentini2,3, Giovanni Scambia2,3, Filippo Crea3,12

 
1Department of Translational Medicine, University of Eastern Piedmon, Novara, Italy
2Fondazione Universitaria Policlinico A. Gemelli IRCCS, Rome, Italy
3Catholic University of the Sacred Heart, Rome, Italy
4Scientific Directorate, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy
5Gemelli Digital Medicine and Health, Rome, Italy
6Innovation Sprint Srl, Bruxelles, Belgium
7Healthcare Innovation, AstraZeneca, Milan, Italy
8Healthcare Service Design, AstraZeneca, London, UK
9Biomagnetism and Clinical Physiology International Center (BACPIC), Rome, Italy
10Cardiology Department, Cannizzaro Hospital, Catania, Italy
11Cardiopulmonary Department, IRCCS San Raffaele Roma, 00166 Rome, Italy; San Raffaele Open University in Rome, Italy
12Center of Excellence of Cardiovascular Sciences, Ospedale Isola Tiberina–Gemelli Isola, Rome, Italy
 
 
 
 
Background

Despite advancements in disease-modifying therapies, the rate of hospitalizations in patients with heart failure (HF) remains high, with an increased risk of future adverse events and healthcare costs. In this context, the AZIMUTH study aims to evaluate the large-scale applicability of a smartphone app-based model of care to improve the quality of care and clinical outcomes of HF patients.

 

Methods

The AZIMUTH trial is a multicentre, prospective, pragmatic, interventional, single-cohort study enrolling HF patients. Three hundred patients will be recruited from four different sites. For comparative analyses, both historical data from participating hospitals for the 6 months before enrollment, along with propensity-matching score analyses from GENERATOR HF DataMart, will be used. The estimated duration of the study is 6 months. During the whole observational period, the patients are asked to provide information regarding their clinical status, transmit remote clinical parameters, and periodically answer validated questionnaires, Kansas City Cardiomyopathy Questionnaire Health and Morisky Medication Adherence Scale 8-item, on a mobile application, through which healthcare providers implement therapeutic adjustments and remote clinical assessments. The primary objective of this study is to evaluate the feasibility, usability and perceived benefits for key stakeholders (patients and clinical staff) of the AZIMUTH digital platform in the enrolled patients when compared to standard of care. Secondary endpoints will be the description of the rate of hospital readmissions, ambulatory visits and prescribed therapy in the 6 months following enrolment in the experimental group compared to both the historical and propensity-matched cohorts.

 

Perspective

The AZIMUTH aims to enhance HF management by leveraging digital technologies to support the care process and enhance monitoring, engagement, and personalized treatment for HF patients.

 
Keywords: Healthentia, Heart Failure (HF), Digital Health, Telemedicine, Remote Patient Management, Personalized Treatment, Clinical Outcomes
 

More Publications

Healthentia
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.