From December 9 to 11, the Cardiovascular Clinical Trial (CVCT) Forum brought together over 400 speakers across 40 sessions at the Mayflower Hotel in Washington, DC. This prestigious event provided a deep dive into the latest clinical trial developments, drawing a global audience of key stakeholders in the cardiovascular, cardiorenal, and cardiometabolic medicine fields.
FH Europe Foundation was proudly represented by CEO Magdalena Daccord, who spoke on the European Health Data Space and its impact on clinical trials in the context of familial hyperlipidaemias. Her insights underscored the importance of collaboration to advance patient-centred care and trial innovations.
A Unique Platform for Clinical Trial Excellence
CVCT Forum is unparalleled in its focus on dissecting individual trial results beyond the brief “Late-Breaking Clinical Trials” presentations typically seen at international conferences. Over three days, attendees participated in detailed discussions led by investigators, statisticians, journal editors, regulators, clinicians, industry experts, payers, and patients. Among the speakers were some of FHEF's partners and friends, including Prof. Borge Nordestgaard - President Elect of the European Atherosclerosis Society, Prof. Erik Stroes from the Netherlands, Prof. Christie Ballantyne, Penilla Gunther from Sweden, and many more.
Expanding Clinical Horizons
This year, CVCT extended its scope beyond cardiology, touching on nephrology, endocrinology, diabetology, pulmonary hypertension, lipidology, cardio-oncology, rare diseases, geriatrics, pediatric cardiology, and more. The program featured three parallel tracks, including a dedicated lipidology track with presentations covering familial hypercholesterolaemia (FH), homozygous FH (HoFH), elevated Lp(a), familial chylomicronaemia syndrome (FCS), and related disorders. Sessions also explored cutting-edge topics such as AI in clinical trials, pediatric trials, and the role of women in trials.
Building Bridges Across Stakeholders
CVCT fosters connections between diverse stakeholders to advance clinical trial science:
A Unique Panel Composition: Experts, Regulators, Sponsors, and Patients Unite
One of the most remarkable aspects of CVCT Forum 2024 was the composition of its panels. The event brought together a dynamic mix of medical and research experts, industry representatives knowledgeable as trial “sponsors”, regulators predominantly from the US Food and Drug Administration (FDA), and many international patients, advocates, and leaders of patient organisations, fostering a truly collaborative environment. Discussions delved into the trial rationale, design, operational issues, statistical interpretation, clinical relevance, and the pathways to approval, reimbursement, and implementation.
This diverse composition ensured that the perspectives of all stakeholders were represented, setting the stage for robust debates and groundbreaking insights. Patients, in particular, played an essential role in these discussions, offering real-world perspectives on the impact of clinical trials.
Going Global: Expanding Representation
CVCT 2024 prioritized inclusivity by expanding its reach to underrepresented regions, including Latin America, Africa, the Middle East, and Asia-Pacific. By involving faculty and regulators from these regions, the forum aims to foster diversity and a truly global approach to clinical trials.
FHEF Key Contributions
In her contribution, FHEF’s CEO - Magdalena Daccord, highlighted the critical role of European Health Data Space (EHDS) in advancing data-driven clinical trials and research with some very specific potential opportunities and challenges in the field of familial hyperlipidaemias. She referred to the importance of electronic health records screening for improved detection of patients with FH, elevated Lp(a), even HoFH and FCS, new frontiers in clinical trials design and meaningful endpoints, as well as challenges like the right approach to patient engagement, informed consent, secondary use of health data, health literacy and the fundamental issue of trust in the context of data collection, use and sharing. Furthermore, Daccord highlighted the importance of continuous and dedicated training of patient experts to be able to meaningfully contribute to clinical trial design, especially in the context of the EHDS. Additionally, she met with patient advocates from around the world, emphasising the importance of global collaboration in addressing unmet needs in genetic CVD risk factors and rare diseases like HoFH and FCS.
Looking Forward: Elevating the Patient Voice
While the Forum effectively integrated patient perspectives, there is significant potential to amplify their role in shaping future therapies. Moving forward, CVCT could benefit from:
A Call for Greater Patient Involvement
The FH Europe Foundation remains committed to championing the voices of patients in all aspects of clinical trial science. By embracing co-creation and prioritizing meaningful outcomes, the clinical trials of tomorrow can better serve the needs of the people they are designed to help. Events like CVCT provide the ideal platform to drive this evolution, ensuring that advancements in medicine translate into real-world benefits for patients worldwide.
The FH Europe Foundation is grateful to the organizers of CVCT Forum 2024 and inspired by the discussions that unfolded over the three days. We are eager to continue engaging with this vibrant community of clinical trialists and patient advocates. Together, we can drive meaningful advancements in evidence-based medicine and improve outcomes for patients worldwide.
Brussels, 3 December, 2024 — The European Union (EU) has adopted Council Conclusions that will set a milestone for the continent’s cardiovascular health. Cardiovascular disease (CVD) – the leading cause of death in the EU and globally – affects more than 60 million Europeans, accounts for over 1.7 million deaths annually on the continent, and costs its economy an estimated €282 billion each year.
The European Alliance for Cardiovascular Health (EACH) welcomes the Council Conclusions which reflect key objectives of the EACH Plan that includes strengthening primary and secondary prevention, early detection and screening, and optimising management and rehabilitative care of CVD. The Council’s recommended actions invite Member States to expand screening programmes for cardiovascular risk factors, address socioeconomic and environmental determinants of health, and increase access to therapy tailored to the needs of patients and families.
The Council Conclusions acknowledge the scale of the challenge, and EACH is pleased to see the EU stepping up with plans and resources that match this immense health and economic burden. Particularly encouraging, is the expressed commitment of the newly appointed Health Commissioner, Olivér Várhelyi, to transform these Council Conclusions into a comprehensive European cardiovascular health plan.
“Early detection and diagnosis, timely intervention and eventually better management of patients with cardiovascular disease and a strong focus on prevention and rehabilitation will result in a significant reduction of premature deaths in Europe” said Prof. Thomas F. Lüscher, President of the European Society of Cardiology, which is currently acting as Secretariat of EACH. “This is important for the individuals and their families and friends. At the same time, it is important for society at large. The EU Cardiovascular Health plan will play an essential part in improving lives and health outcomes for citizens allowing them to actively take part in, and contribute to, society.”
The Council Conclusions also call on the European Commission to ensure adequate funding and to map cardiovascular health actions in an integrated way, through primary, secondary and tertiary care. Proposed steps include promoting evidence-based prevention measures, advancing innovative treatments, and leveraging digital health tools for better data integration and research. These actions aim to reduce risk factors common to both cardiovascular diseases and cancer, such as poor nutrition, tobacco use, and physical inactivity.
EACH welcomes the inclusion of public health campaigns to improve health literacy and expand access to automated external defibrillators (AEDs) in community spaces. These efforts, alongside commitments to environmental health measures such as reducing air and noise pollution, reflect a comprehensive strategy to tackle the root causes of cardiovascular diseases.
For more information about EACH, please visit: www.cardiovascular-alliance.eu
About EACH
The European Alliance for Cardiovascular Health (EACH) brings together leading European and international organisations around joint activities to promote cardiovascular health as a policy priority at EU level. The Alliance provides a platform to aggregate knowledge and expertise of key stakeholders active in the field of cardiovascular health, and to advise and guide policymakers. The Alliance calls for greater focus on improving cardiovascular health and reducing the burden cardiovascular disease at European level. The Alliance was officially launched on 27 September 2021 during a high-level policy debate attended by representatives of the European Commission, Member States and the European Parliament. The Alliance partners cover all aspects of cardiovascular care: from the patients who suffer from the disease to the clinicians and health professionals who take care of them, to research organisations, and industries that develop the medical and technological innovations to improve the management and care of CVD.
Explore the highlights from FH Europe's November 2024 Heart Beat newsletter to catch up on the latest news and events in the world of cardiovascular health:
“Last Monday, November 18th, my family and I had the honour to speak at the EACH (European Alliance for Cardiovascular Health) event, held at The Hotel in Brussels. Titled “Rising to the Challenge: Time for Action to Cardiovascular Health”, this was the second gathering aimed at advocating for a Cardiovascular Health Plan for Europe. The event united several key stakeholders, including policymakers, healthcare professionals, industry representatives, and patient advocates, to discuss further actions that have to be taken to improve cardiovascular health across Europe.
Cardiovascular diseases (CVD) are the number one cause of death in Europe, and my family has unfortunately experienced first-hand how destructive and impactful cardiac events are. My father, Marc Rijken, and two sisters, Arwen and Beau were all diagnosed with elevated Lp(a); a genetic lipid disorder running in the families that increases the risk of premature cardiovascular disease, for which there are no approved medicines available as of yet. As ambassadors of the FH Europe Foundation, my family and I strive for early screening and detection and increased investment in research to develop medicine for elevated Lp(a) and other familial lipid disorders and CVD risk factors. We firmly believe that no family should, or has to, endure what we have experienced.
When the Cardiovascular Health Plan is accepted and implemented, this will increase detection of cardiovascular disorders throughout Europe before it is too late, and save many lives doing so. At the EACH event, my family had the chance to get our voices heard, and tell our story, urging the Members of the European Parliament (MEPs) to not only put cardiovascular health on the agenda but take the action that is needed! Being able to speak directly to MEPs both at this event, as well as at the kick-off event last year in Strasbourg has been very inspiring and has made our advocacy journey feel more impactful. However, what makes EACH event particularly special, is connecting with other ambassadors and advocates who share our vision for a healthier future. These moments of solidarity, with my family and others, remind us of the collective strength behind this movement and the importance of working together to reach our shared goal and drive change.
But, we cannot stop here. Our advocacy journey has only just started. The coming months will be crucial in the development of the EU Cardiovascular Health Plan. So, let’s all keep coming together for change, and hold our policymakers accountable for their commitments. Together, we can create a future where cardiovascular health is a priority for all. On to a better future.
#VOTEHEALTH 2024,
India Rijken <3
