P95 Julius Clinical team at ESC 2026 in Munich

The P95 Julius Clinical team recently joined researchers, sponsors, clinicians, and industry leaders in Munich for ESC Congress 2026. Across scientific sessions, new clinical guidance, and industry discussions, several themes emerged that could influence the next generation of cardiovascular research: a more individualized approach to prevention, continued momentum behind cardiometabolic therapies, growing expectations for rigorous evidence generation, and the use of imaging and artificial intelligence to support more precise and efficient care.

While scientific and technological innovation continues to move quickly, discussions throughout the congress also highlighted a recurring challenge. Cardiovascular risk is complex, and translating new evidence into clinical practice requires more than a single measurement, risk score, or treatment threshold.

Cardiovascular Prevention Is Becoming More Personalized

One of the clearest themes at ESC 2026 was the continued evolution of cardiovascular prevention from a threshold-based model toward a more individualized assessment of risk.

Blood pressure remains one of the most important modifiable cardiovascular risk factors, but treatment decisions are increasingly informed by a broader view of the patient. Age, comorbidities, existing cardiovascular disease, evidence of organ damage, treatment tolerability, and expected lifetime exposure can all influence the balance between benefit and risk.

The discussions in Munich reinforced that patients with similar blood pressure measurements may have very different clinical profiles and treatment needs. Likewise, a patient who appears to have low short-term cardiovascular risk may still face substantial lifetime risk if elevated blood pressure or other risk factors remain untreated for many years.

For sponsors, this shift has important implications for clinical trial design. Eligibility criteria based on a single threshold may not adequately capture the population most likely to benefit from treatment. More comprehensive approaches that combine conventional risk factors with biomarkers, imaging, evidence of target-organ damage, or lifetime-risk estimates may support more precise patient selection.

This more personalized framework could also help explain why treatment effects differ across study populations, enabling sponsors to identify both the patients most likely to benefit and those who may require additional safety monitoring.

Short-Term Risk Does Not Capture Lifetime Disease Burden

Cardiovascular risk tools are valuable for estimating the likelihood of an event over a defined period, but discussions at ESC emphasized that short-term projections do not always capture the cumulative effects of disease.

This is particularly relevant for younger patients. Because age is a major component of many cardiovascular risk models, younger adults can be classified as having low short-term risk even when they have markedly elevated blood pressure or other significant risk factors. Over time, continued exposure can contribute to cardiac, renal, and cerebrovascular injury that may be difficult to reverse once established.

This creates an important tension in cardiovascular prevention. Focusing only on short-term risk may prioritize treatment for older or higher-risk patients while delaying intervention for younger individuals with substantial lifetime exposure. At the same time, treating broad lower-risk populations requires careful consideration of safety, tolerability, adherence, cost, and the absolute benefit expected for each patient.

For clinical development programs, these discussions underscore the need to consider the time horizon of both the disease and the trial. Traditional cardiovascular outcomes may take years to emerge in lower-risk populations. Sponsors may therefore need to evaluate intermediate measures, imaging findings, biomarkers, or indicators of target-organ injury that can demonstrate whether an intervention is altering the course of disease before major clinical events occur.

Benefit-Risk Assessment Is Becoming More Nuanced

Another important takeaway from ESC was that evidence of treatment efficacy must be considered alongside the scale and clinical significance of potential harms.

Preventive therapies may produce meaningful reductions in cardiovascular events across a broad range of patients, but the absolute benefit is not necessarily the same for everyone. In lower-risk populations, even a consistent treatment effect may translate into a smaller absolute benefit. Adverse effects, treatment burden, and patient preferences can therefore play a larger role in determining whether treatment is appropriate.

This reinforces the importance of moving beyond simplified conclusions about whether a therapy “works.” The more relevant question is which patients are most likely to experience a meaningful net benefit and under what conditions.

For sponsors, benefit-risk planning should begin early in development. Trials may need to characterize efficacy and safety across clinically relevant subgroups while also assessing treatment discontinuation, tolerability, quality of life, and patient-reported outcomes. These considerations can be particularly important when a therapy may be used for many years or introduced earlier in the course of disease.

Cardiometabolic Therapies Are Expanding the Scope of Prevention

GLP-1-based therapies remained an important topic of discussion at ESC 2026, reflecting their growing role across obesity, diabetes, and cardiovascular disease.

Enthusiasm continues to build around their potential to influence cardiovascular outcomes, particularly among patients with elevated cardiometabolic risk. At the same time, questions remain about how broadly these therapies should be used in primary prevention and how clinicians should identify the patients most likely to derive meaningful long-term benefit.

The discussions also suggested that the impact of these therapies may extend beyond weight reduction alone. Changes in appetite, food selection, alcohol consumption, and other health behaviors may contribute to their broader cardiometabolic effects. Understanding these changes could provide a more complete picture of how treatment influences cardiovascular health.

For sponsors, this expanding therapeutic landscape creates new questions for clinical development. Future trials may need to determine how early treatment should begin, which patient characteristics predict response, and which endpoints best capture the multiple effects of therapy.

Development strategies may also need to address real-world considerations such as treatment persistence, long-term adherence, cost, access, and health-system capacity. As use expands, generating evidence that supports implementation may become nearly as important as demonstrating clinical efficacy.

Prof. Rick Grobbee, Chief Scientific Officer at P95 Julius Clinical, attended ESC Congress 2026 and hosted the Sunday ESC TV Day in Focus session

Prof. Rick Grobbee, Chief Scientific Officer at P95 Julius Clinical, also attended ESC Congress 2026 and hosted the Sunday ESC TV Day in Focus session, recapping the day’s most important congress highlights and key scientific developments. For his deeper perspective on why cardiometabolic innovation is moving beyond weight loss toward cardiovascular, renal, and metabolic outcomes, read Beyond Weight Loss: Why the Next Phase of Cardiometabolic Innovation Will Be Defined by Outcomes.

Rigorous Trial Designs Require Meaningful Patient Engagement

ESC 2026 also highlighted the continued importance of rigorous control groups, particularly in trials evaluating procedures and device-based interventions.

Sham-controlled studies can strengthen evidence by helping researchers distinguish the physiological effect of an intervention from placebo effects and other changes associated with study participation. However, these designs can create significant recruitment, ethical, and operational challenges.

Patients may be asked to undergo an invasive procedure without receiving the active intervention. Even when the scientific rationale is strong, participation can be difficult to explain and may be unacceptable to many potential participants.

The takeaway for sponsors is clear: methodological rigor and patient engagement must be developed together. Shared decision-making, transparent communication, and a clear explanation of the value of the control group are critical to informed participation.

Patient input should therefore begin early in protocol development. Patient advisory panels, informed-consent testing, site training, and feasibility research can help sponsors identify potential barriers before recruitment begins. These activities can improve study participation and retention without compromising the quality of the evidence being generated.

EMR Data Can Support Recruitment in Large Cardiovascular Trials

Conversations with sponsors at ESC also highlighted the potential for electronic medical record data to support recruitment and screening in large cardiovascular outcomes trials. These studies may need to enroll thousands of participants, making the timely identification of potentially eligible patients a significant operational challenge.

By translating complex inclusion and exclusion criteria into searchable or computable logic, sponsors and research partners can use EMR data to identify potential participants across large patient populations. This approach may help sites focus their screening efforts, reduce the burden of manual chart review, and identify patients who might otherwise be overlooked.

EMR data can also support trial planning before recruitment begins. Sponsors may be able to use available demographic, medical history, laboratory, and imaging data to assess protocol feasibility, refine eligibility criteria, select countries and sites, and estimate the availability of suitable patients. However, effective implementation requires early attention to data quality, interoperability, privacy, informed consent, and differences among local healthcare systems.

For cardiovascular trials with large enrollment targets, incorporating EMR-supported recruitment into the feasibility and operational strategy may help improve screening efficiency and accelerate enrollment while allowing investigators to retain responsibility for determining patient eligibility.

For practical insight into the opportunities and challenges associated with EMR-supported recruitment and data collection, read our interview with Prof. Rick Grobbee: Making EMR Data Work for Your Clinical Trial.

Imaging and AI Are Supporting More Efficient Cardiovascular Research

Non-invasive cardiovascular imaging was another prominent theme, particularly in discussions about creating faster, more precise, and more efficient diagnostic pathways.

Advances in imaging are making it possible to characterize cardiovascular disease in greater detail, detect changes earlier, and improve patient stratification. At the same time, artificial intelligence is increasingly being explored as a tool to support image acquisition, interpretation, triage, and workflow management.

Rather than replacing clinical expertise, AI may help clinicians and researchers work more consistently and efficiently. In clinical trials, standardized imaging and AI-supported analysis could improve eligibility assessment, strengthen endpoint reproducibility, and help identify treatment effects that might not be captured through traditional clinical measures alone.

These opportunities also introduce new operational and regulatory considerations. Sponsors need to account for differences in imaging equipment, acquisition protocols, and site capabilities. Trials incorporating AI-enabled technologies may also require clear validation plans, appropriate human oversight, traceable data, and strategies for managing software or algorithm updates during the study.

When implemented thoughtfully, imaging and AI may support more precise cardiovascular trials while reducing variability and accelerating decision-making.

What This Means for Future Cardiovascular Development

ESC 2026 reinforced that cardiovascular research is moving toward a more integrated and personalized model of prevention.

Treatment decisions are increasingly shaped by the interaction between short-term risk, lifetime disease burden, safety, patient preferences, and the feasibility of long-term therapy.

Cardiometabolic medicines are broadening the boundaries of cardiovascular prevention, while EMR data, imaging, and AI are creating opportunities for more efficient recruitment, earlier detection, and more precise trial execution.

At the same time, the continued focus on rigorous controls and patient-centered research shows that innovation in clinical development is not limited to new therapies or technologies. It also includes how studies are designed, how evidence is interpreted, and how patients are involved.

For sponsors developing cardiovascular therapies and technologies, success will increasingly depend on:

  • Selecting study populations using a combination of clinical and biological risk indicators
  • Considering lifetime disease burden alongside short-term event risk
  • Choosing endpoints that capture disease progression as well as major cardiovascular events
  • Defining benefit and risk across clinically meaningful patient subgroups
  • Incorporating patient perspectives into complex or invasive trial designs
  • Using EMR data to strengthen feasibility, identify potential participants, and support recruitment in large cardiovascular trials
  • Standardizing imaging acquisition and interpretation across sites
  • Planning early for the validation and governance of AI-enabled technologies
  • Generating evidence that supports access, adoption, and real-world implementation

Looking Ahead

The conversations in Munich highlighted a cardiovascular field that is becoming more precise, more preventive, and more attentive to the complexity of individual treatment decisions.

Scientific advances are creating opportunities to identify cardiovascular risk earlier and intervene more effectively. The next challenge is translating those advances into clinical development programs that generate robust evidence while remaining feasible for investigators, meaningful to patients, and aligned with regulatory expectations.

At P95 Julius Clinical, we help sponsors translate emerging cardiovascular evidence into effective development strategies, from patient selection and endpoint planning to global trial delivery. Connect with our cardiovascular experts to discuss how evolving approaches to risk assessment, hypertension, cardiometabolic disease, imaging, and trial methodology could inform your next clinical development program.