This study will be a non-profit, prospective, 1:1 randomized, single-center intervention study, conducted at the Department of Clinical and Molecular Medicine at the University of Rome Sapienza in collaboration with the Excellence European Hypertension Center of the Cardiology Division at the University Hospital Sant'Andrea in Rome [22]. The study is promoted and supported supported by the Italian Society of Cardiovascular Prevention (SIPREC) and has been submitted to the Ethic Committee “Territoriale Area Lazio 1”.

The study will be conducted over a 36-month period (Fig 1). During the first three months of the project, the Heartaway® App, developed by the Department of Clinical and Molecular Medicine at the University of Rome Sapienza, will be internally tested by the investigators.

In the subsequent 6 months, consecutive patients with hypertension attending the Hypertension Center at the University Hospital Sant'Andrea will be enrolled. Inclusion criteria include age > 18 years, the ability to provide informed consent, possession of a smartphone with iOS or Android operating systems, a diagnosis of hypertension, and at least one other cardiovascular risk factor, evidence of subclinical target organ damage, or previous cardiovascular disease.

Exclusion criteria include NYHA class III-IV heart failure, ongoing hemodialysis, poor prognosis due to cancer, pregnancy, unavailability of laboratory tests required for a comprehensive cardiovascular risk assessment, and contraindications to telemedicine.

After obtaining written informed consent, enrolled patients will be randomly assigned to either the Heartaway® App group (intervention group) or the standard clinical care group (control group) in a 1:1 ratio using the Biased Coin method (estimated sample size 220 patients, 110 per group). The randomization process will be performed by a research support unit.

All patients will receive standard clinical care according to the European Society of Cardiology guidelines, including at least yearly clinical assessment, anthropometric measurements, physical examination, vital signs measurements, laboratory tests, and electrocardiograms. The follow-up of these patients will continue for the following 24 months.

The Heartaway® app, is an application developed for use on a smartphone (iOS or Android). With a self-registration, each subject of the intervention group should provide information about anthropometric data, cardiovascular risk factors, cardiovascular diseases and other comorbidities, current drug therapy and laboratory data. Based on these information, the Heartaway® app will calculate the SCORE-2/SCORE-2 OP, a new algorithm to estimate 10-year risk of CV disease in apparently healthy people, described in 2021 by European Society of Cardiology guidelines [6]].

The most interesting app functionality is the weekly telehealth visit consisting in questions about vital parameters, fluid intake, body weight, onset or deterioration of chest pain, dyspnea, palpitation and peripheral swelling. The App, based on an algorithm capable to integrate subject answers, will provide automatically to the medical staff a report on each patient cardiovascular health. At each annual study visit, a structured patient interview will be administered face-to-face by a study coordinator to assess app usability and collect recommendations for app improvement.