Abstract
The recent pandemic ushered in a marked surge in the adoption of digital health technologies (DHTs), necessitating remote approaches aiming to safeguard both patient and healthcare provider well-being. These technologies encompass an array of terms, including e-health, m-health, telemedicine, wearables, sensors, smartphone apps, digital therapeutics, virtual and augmented reality, and artificial intelligence (AI). Notably, some DHTs employed in critical healthcare decisions may transition into the realm of medical devices, subjecting them to more stringent regulatory scrutiny. Consequently, it is imperative to understand the validation processes of these technologies within clinical studies. Our study summarizes an extensive examination of clinical trials focusing on cardiovascular (CV) diseases and digital health (DH) interventions, with particular attention to those incorporating elements of AI. A dataset comprising 107 eligible trials, registered on clinicaltrials.gov and International Clinical Trials Registry Platform (ICTRP) databases until 19 June 2023, forms the basis of our investigation. We focused on clinical trials employing DHTs in the European context, revealing a diverse landscape of interventions. Devices constitute the predominant category (45.8%), followed by behavioral interventions (17.8%). Within the CV domain, trials predominantly span pivotal or confirmatory phases, with a notable presence of smaller feasibility and exploratory studies. Notably, a majority of trials exhibit randomized, parallel assignment designs. When analyzing the multifaceted landscape of trial outcomes, we identified various categories such as physiological and functional measures, diagnostic accuracy, CV events and mortality, patient outcomes, quality of life, treatment adherence and effectiveness, quality of hospital processes, and usability/feasibility measures. Furthermore, we delve into a subset of 15 studies employing AI and machine learning, describing various study design features, intended purposes and the validation strategies employed. In summary, we aimed to elucidate the diverse applications, study design features, and objectives of the evolving CV-related DHT clinical trials field.