A new European framework for cardiovascular health
Cardiovascular diseases remain the leading cause of death in Europe, representing a shared and growing burden for citizens, health systems, and societies. With the adoption of the first-ever EU Cardiovascular Health Plan – the Safe Hearts Plan, the European Commission has set out a comprehensive and long-term framework to address this challenge.
Developed through extensive consultation with Member States, public health experts, citizens’ groups and representatives from the research and policy community, the Plan places strong emphasis on health promotion and prevention, early detection and screening, and personalised care, supported by innovation, research, and a clear commitment to reducing inequalities.
While the Safe Hearts Plan represents Europe’s response to this challenge, cardiovascular disease remains a leading cause of death worldwide, underscoring the global relevance of effective, prevention-oriented approaches.
CARAMEL as an early enabler of the Safe Heart Plan vision
“As the coordinator of CARAMEL, Vicomtech is proud to act as an early enabler for the EU Safe Hearts Plan. Our project was designed around the same core priorities—personalized prevention, digital innovation, and reducing inequalities—that now underpin Europe’s first-ever comprehensive cardiovascular health framework. By leveraging AI-driven risk models specifically tailored for women aged 40–60, we are providing the real-world evidence and digital tools necessary to translate the Plan’s vision into concrete, proactive care pathways. Together with the Safe Hearts Plan, we are committed to closing long-standing research gaps and ensuring that advanced, equitable heart health monitoring becomes a reality for every woman in Europe.” – Dr. Ivàn Macia, VICOMTECH (SP)
Conceived before the formal adoption of the Safe Hearts Plan, CARAMEL was designed around many of the same priorities that now define Europe’s cardiovascular agenda. The project focuses on personalised prevention and early risk identification for women aged 40-60 years, leveraging the responsible use of digital and AI-driven technologies to anticipate the direction set by the Commission. In this sense, CARAMEL acts as an early enabler to combat cardiovascular disease, generating real-world evidence, digital tools, and implementation experience that can support the translation of European priorities into concrete and feasible prevention strategies within real healthcare settings.
Where CARAMEL connects to the Safe Hearts Plan
CARAMEL’s approach closely aligns with several key flagship initiatives of the Safe Hearts Plan. At its core, the project contributes to the vision of lifelong, personalised and digitally enabled prevention promoted under the “EU cares for your heart” programme, by developing AI-based risk assessment models tailored to women’s cardiovascular profiles. At the same time, CARAMEL reflects the Plan’s ambition to integrate artificial intelligence and digital innovation into cardiovascular care, by testing and validating advanced tools directly within clinical practice. Importantly, by focusing on women aged 40–60, a population whose cardiovascular risk remains underestimated, the project directly supports the Plan’s cross-cutting objective of addressing inequalities and contributing to the reduction of long-standing research gaps in cardiovascular health.
“CARAMEL shares the commitment of the Safe Hearts Plan in transforming the path to cardiovascular prevention. Shifting the future of cardiovascular medicine from a reactive to a proactive approach, CARAMEL brings forth the next generation of digital health tools, including advanced AI-driven systems, connected wearables, remote monitoring, and cutting-edge imaging to predict cardiovascular risk for women with greater precision than traditional scoring models. Co-designed with women and for women, CARAMEL technologies adhere to relevant quality, safety and privacy standards, and ensure personalised and optimised preventive care pathways, accessible to all, bridging the digital divide and improving equity and access in cardiovascular care delivery.” – Dr. Marco Manso, PARTICLE Summary (PT).
Beyond these core areas, CARAMEL also generates evidence that may inform future European efforts on early risk identification, support more personalised monitoring approaches, and strengthen research-driven policy development, contributing to a stronger knowledge base for cardiovascular health in Europe.
What this means for women’s cardiovascular health
“CARAMEL’s preliminary findings show that many women do not see themselves as potential candidates for heart disease and are often unaware that their risk increases during menopause. The Safe Hearts Plan and the CARAMEL study are working toward the same goal: helping women recognise this risk earlier and take action sooner. The Safe Hearts Plan creates the broad framework for awareness, prevention, and early detection, while CARAMEL brings together women-specific insights, and sex & gender-specific evidence that reflect biological, hormonal, and social factors influencing women’s cardiovascular health and well-being. Together, they support the translation of evidence into targeted assessment tools, prevention strategies, public health messaging, and early-intervention approaches that strengthen cardiovascular outcomes for women.” – Professor Sharon O’Donnell, Trinity College Dublin (IE).
The Safe Hearts Plan recognises that effective prevention must reach people earlier and more equitably. This is particularly relevant for women in midlife, whose cardiovascular risk often increases during the menopausal transition but is still insufficiently captured by traditional models. By placing women at the centre of its design, CARAMEL supports greater awareness of individual cardiovascular risk and the development of prevention pathways that are tailored to women’s specific needs, alongside digital tools that enable informed and proactive health choices. In doing so, the project helps make prevention more accessible and relevant in everyday life, moving beyond generic recommendations towards approaches that reflect women’s lived experiences and real health trajectories.
Co-creating prevention with women, not just for women
Effective cardiovascular prevention cannot be designed in isolation from the people it seeks to protect. In line with the Safe Hearts Plan’s emphasis on early, equitable, people-centred, and personalised approaches, CARAMEL places women’s lived experiences at the centre of innovation through a strong co-creation and patient and public involvement approach. Women participating in CARAMEL contribute both as study participants and as active partners in shaping digital tools and prevention pathways. This inclusive approach is especially important for women whose needs are often overlooked, such as women with intellectual disabilities, for whom traditional prevention models and digital solutions may not be accessible or appropriate. By co-designing solutions together with women, CARAMEL helps ensure that personalised prevention is not only technologically advanced, but also empowering and capable of supporting informed choices across diverse life contexts.
“It has been a privilege to be part of the CARAMEL patient partnership, where we have genuinely been made to feel like equal partners. Our experiences are not just listened to—they are helping to shape the way forward in raising awareness of cardiovascular risk during menopause and what can be done about it. I look forward to continuing in this role to help ensure that information about these risks is accessible to all women, not only those experiencing menopause, but also younger women, so they can take action earlier to reduce risk and, importantly, recognise when action is needed even if prevention is no longer possible.” – Participant in the PPI Committee (IE).
From research to future policy impact
A key ambition of CARAMEL is to ensure that innovation does not remain confined to research settings but can inform decision-making beyond the project itself. By validating AI-driven risk models across diverse populations and healthcare contexts, the project produces robust, real-world evidence that can support future guidelines, prevention plans, and decision-making processes at national and European level. At the same time, this evidence also informs international practice and research discussions, drawing on validation activities conducted across multiple healthcare contexts, including Europe, Colombia and Israel. In this way, CARAMEL contributes to strengthening the implementation capacity of the Safe Hearts Plan and to shaping more effective, prevention-oriented cardiovascular strategies for over time.
“At CARAMEL-Colombia, we have identified that approximately 40% of our women participating in the project in Bogotá (City) lack knowledge about menopause, and most underestimate their risk of dying from cardiovascular disease. This figure is particularly concerning given the rural populations and those with limited access to healthcare services in Colombia and Latin America.
CARAMEL presents an opportunity to improve menopausal health and heart health for women in the region by empowering women to manage their cardiovascular health themselves, as well as by encouraging healthcare providers, governments, and policymakers to focus their efforts on caring for this population”. – Kelly Rocio Chacon Acevedo, Keralty (CO).
Looking ahead
As Europe advances its cardiovascular agenda through the Safe Hearts Plan, projects like CARAMEL demonstrate how research and innovation can actively support policy goals while delivering tangible benefits for people. By combining personalised prevention, digital innovation, and a strong focus on women’s health, CARAMEL aims to contribute to a long-term transformation of cardiovascular care, one that is grounded in evidence, attentive to inequalities, and closely connected to real-world needs.
“Working on CARAMEL, we are not just communicating research results but contributing to a broader change in how women understand and take care of their cardiovascular health. Our goal is to empower, and as a woman involved in this project, I feel deeply connected to its mission to change the narrative around women’s cardiovascular health, giving it the attention and action it deserves.” – Giulia Onorati, Socialit (IT)
