EXIT-CVD research consortium launches clinical studies to transform cardiovascular care across Europe

Five-year research project unites 42 public and private partners across 17 countries to conduct 22 clinical studies involving 14,000+ patients; first patients will be enrolled this month

• Project aims to help cardiac patients avoid deterioration through early, personalized interventions delivered across the cardiac care journey

• Interventions will be co-created with patients and designed to systematically address socioeconomic, sex- and gender-related and digital access gaps

• With a total budget of EUR 27.6 million, the project is co-funded by the European Union Innovative Health Initiative (IHI) and industry partners

London, UK – **Onsentia today announced the launch of the five-year EXIT-CVD research project, co-funded by the European Union Innovative Health Initiative (IHI) and the industry partners. The research consortium is led by University Medical Center Groningen (UMCG) and Philips, and aims to transform how cardiovascular disease is detected, monitored and treated. It will do so by identifying and acting on three key exit points along the cardiac care journey: preventing disease before it develops (early exit), reversing disease progression (mid exit), or halting progression in advanced stages (late exit). Patient enrollment for the first of the 22 clinical studies will begin this month.

Cardiovascular health is fundamental to overall health and well-being, yet more than 60 million people in the European Union are living with cardiovascular disease. For many, the condition significantly reduces quality of life and well-being. Without early detection, timely diagnosis and appropriate treatment, cardiovascular disease can progress silently from early risk factors to established disease and ultimately, cardiac events that may lead to premature death.

“Our vision is a future where heart disease is no longer an irreversible pathway,” said Professor Pim van der Harst, Project Coordinator of EXIT-CVD and Head of Cardiology at the University Medical Center Groningen. “By understanding both the biological and social drivers of cardiovascular disease, and deploying integrated innovations across diagnostics, monitoring, and care, we can empower patients and clinicians to exit the disease continuum before it’s too late.”

“For more than 30 years, we have viewed cardiovascular disease as a continuous journey, from risk factors such as hypertension, to atherosclerosis, a first cardiac event and ultimately, for many patients, heart failure,” said Robin Nijveldt, Chief of Cardiology at UMC Utrecht. “Yet most of us improve care within our own specialty and rarely have a complete view of the patient’s experience. EXIT-CVD is an ambitious effort to build that holistic view together, helping transform cardiac care for millions of patients across Europe.”

The EXIT-CVD clinical studies will focus on the three key exit points along the cardiac care journey: early detection through digital monitoring (early exit), personalized risk assessment and targeted interventions (mid exit), and advanced therapies to support recovery in later-stage disease (late exit). By combining diagnostics, digital tools and advanced therapeutic approaches, EXIT-CVD aims to deliver actionable, evidence-based strategies that can be implemented across diverse healthcare systems in Europe.

Innovation that reaches everyone

New diagnostics and digital tools often reach well-resourced populations first, widening gaps in access and outcomes. The project will therefore embed implementation science and equity-by-design principles to ensure that the solutions are scalable, sustainable, and accessible to all relevant populations, including those historically underserved. A digitally enabled, FAIR-compliant data platform aligned with the European Health Data Space (EHDS) will support the integration, evaluation, and real-world scalability of the project's innovations.

Onsentia + EXIT-CVD ♥️

"By harnessing mobile health technology and the open-source RADAR-base platform, Onsentia is proud to power the digital data collection and remote monitoring infrastructure for EXIT-CVD," said Amos Folarin, CEO of Onsentia. "Our mission is to make health data effortless to collect and act on, enabling real-time insights from wearables and mobile devices that empower researchers and clinicians to intervene earlier and improve patient outcomes across Europe."

Onsentia provides a flexible, secure, and GDPR-compliant digital health platform built on the open-source RADAR-base (see prior use in digoxin versus beta-blockers cardiovascular trial, Gill et al., Nature Medicine, 2024, cited in the NHS 10 Year Plan). By combining active patient-reported outcome measurements (aRMT) with broad passive sensor and wearable data collection (pRMT), Onsentia and RADAR-base enable multi-source, scalable, real-time remote monitoring and data integration across modern clinical trials. The platform offers several improvements that enable better study management and participant monitoring. From establishing end-to-end studies through intuitive, user-friendly interfaces to overseeing participant data and dispatching adherence notifications, Onsentia's platform manages all aspects seamlessly. AI assistants aid researchers and clinical trial teams in maintaining oversight of the study, thereby reducing costs, time, and the overall burden associated with study management. Onsentia will be participating in two studies in the "early exit": COMPASS and EMPOWER-BP.

Led by King’s College London (KCL)/GSTT, the COMPASS study brings together unique technological capabilities from several partners. Huawei Health provides the underlying ambulatory blood pressure monitoring via its D3 Watch, which uses a novel integrated oscillometric wrist BP cuff. Onsentia's decentralized remote monitoring platform collects data from the Huawei D3 Watch. MEGI provides an AI-powered digital health app that delivers personalized cardiovascular and maternal heart care assessments, and CogStack will assist in identifying participants from the medical record and generate harmonised data from the electronic health record to complement the real-world dataset.

Universitair Medisch Centrum Utrecht (UMCU), together with Univerista’ Di Pavia (UNIPV), Politecnico Di Milano (POLIMI) and Stichting Vrouwenhart, the EMPOWER-BP Study utilizes a citizen science approach, recruiting participants to Onsentia's platform and enabling remote self-enrolment via social media and the Huawei D3 Watch wearable. This study seeks to engage patients directly in their health management, enhancing adherence and reducing healthcare costs.

Clinical studies

The EXIT-CVD research consortium will conduct a total of 22 clinical studies involving more than 14,000 patients across Europe, including:

• Camera-Based In-Hospital Monitoring (CARDIO-CAM study): Deployment and evaluation of an unobtrusive, video-based patient monitoring system that continuously captures cardiorespiratory signals and relevant clinical context.

• Spectral CT for Early Detection, Risk Stratification and Personalized Patient Care Pathways (LEADER-PAD study): Development and validation of new approaches for the early detection of cardiovascular disease in asymptomatic and low risk symptomatic patients using spectral CT. 

• Nurse/HCP-Led Remote Heart Failure Monitoring (REMODEL-HF study): Multinational randomized study evaluating the Heart Failure Management System (HFMS), a non-invasive remote monitoring technology, in patients recently hospitalized for heart failure, with the objective of improving outcomes and optimizing guideline-directed medical therapy.

• Imaging-Guided PCI Randomized Trial (GUIDANCE-PCCT study): Evaluation of clinical and procedural outcomes of PCI guided by photon counting CT versus standard angiography-guided PCI.

• Advanced Imaging in Infiltrative Cardiomyopathies (NOTIFY-2 study): Validation of AI-driven image and ECG analysis algorithms to improve early diagnosis of Left Ventricular Hypertrophy (LVH) and underlying disease risk stratification.

Consortium partners

The IHI EXIT-CVD public-private partnership comprises 42 partner organizations from 17 countries:

• Clinical and academic partners: Hospital de la Santa Creu i Sant Pau (Spain), Politecnico di Milano (Italy), University of Pavia (Italy), Centro Cardiologico Monzino (Italy), EOC (Switzerland), KU Leuven (Belgium), NIKARD (Poland), UMC Utrecht (Netherlands), UMC Groningen (Netherlands), Technical University Eindhoven (Netherlands), Universitätsklinikum Köln (Germany), King’s College London (UK), London School of Economics and Political Science (UK), and Varsinais-Suomen Hyvinvointialue (Finland).

• Industry partners: Philips, Circle CVI, GE Healthcare, Siemens Healthineers, HeartBeam, Medtronic, Huawei, XVIVO Perfusion, AstraZeneca, Cardiomed, Megi Health, Viatris, Cordys, Novartis, Corbotics, ZOLL, Sanofi, Repairon, Johnson & Johnson MedTech Heart Recovery, Onsentia, and CogStack

• Healthcare consultancy: Bridg Ou and IQVIA Solutions

• Patient organization: Stichting VrouwenHart

• Medical association: European Society of Cardiology (ESC)

More information can be viewed on the EXIT-CVD website. 

This project is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement No 101253160. The JU receives support from the European Union's Horizon Europe research and innovation program and COCIR, EFPIA, Europa Bío, MedTech Europe, and Vaccines Europe. Funded by the European Union, the private members, and those contributing partners of the IHI JU. Views and opinions expressed are those of the author(s) only and do not necessarily reflect those of the aforementioned parties. Neither of the aforementioned parties can be held responsible for them.

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Media Relations – Onsentia

E-mail: hello@onsentia.com 

About Onsentia & RADAR-base

Onsentia is a digital health technology platform dedicated to making mobile health data effortless to collect, interpret, and act on. Built upon the scalable open-source RADAR-base platform—co-developed by King's College London and The Hyve—Onsentia provides secure, GDPR- and FAIR-compliant software solutions, active and passive remote monitoring applications, custom enrolment portals, and real-time data analytics for clinical research and longitudinal studies across Europe and worldwide. Learn more at www.onsentia.com and www.radar-base.org.