Cardiovascular disease (CVD), a broad term for conditions affecting the heart and blood vessels, remains the leading cause of death globally, currently accounting for approximately 18 million deaths each year. As global diets and lifestyles continue to trend toward unhealthy patterns, risk factors such as obesity, diabetes, and hypertension are becoming increasingly common, driving a sharp projected rise in the global burden of CVD.

This growth is further compounded by demographic shifts as populations age, with the prevalence of cardiovascular diseases significantly higher among older adults.  While advances in healthcare are expected to reduce mortality rates and disability-adjusted life years, the absolute number of CVD cases and deaths will climb dramatically – reaching an estimated 35.6 million deaths by 2050.

The picture is further complicated by racial and ethnic disparities. In the US, for example, the CARDIA study found that Black adults are significantly more likely to develop hypertension, placing them at greater risk of heart attack, heart failure, and strokes. Approximately three in every four Black Adults who participated in the longitudinal study developed high blood pressure by age 55, compared to 55% of White men and 40% of White women.

The cardiovascular therapeutic area spans a broad range of interventions – from lifestyle changes like diet and exercise to advanced procedures such as stent placement and pacemaker implantation. According to GlobalData’s Pharmaceutical Intelligence Center, there are more than 2,000 cardiovascular drugs in active development as of December 2025, while the number of new clinical trials initiated in this area surged by 68% between 2015 and 2024.

Among ongoing and planned cardiovascular clinical trials, the most common indications (outside of ‘cardiovascular disease’ and ‘cardiovascular risk factors’) include hypertension, cerebrovascular disease, stroke, congestive heart failure, coronary artery disease, ischemic stroke, and myocardial infarction.

When treating cardiovascular diseases, well-established drug modalities include antihypertensives, anticoagulants, and cholesterol-lowering agents. There is also a growing pipeline focused on advanced and personalized therapies, including RNA-based drugs and regenerative medicines for repairing damage caused by heart attacks or heart failure. Exploring the pipeline of almost 700 cardiovascular drugs that are currently in clinical development (Phase I-III trials), small molecules account for the majority at 51%, followed by biologics at 43% and oligonucleotides at 6%. A similar close split can be seen with route of administration; 52% of the clinical-stage drugs are administered by injection, while 44% are oral drugs.

Cardiovascular trials in the community

Clinical trial delivery is also undergoing a notable shift with the growing adoption of community-based research models in cardiovascular protocols. Community-based research brings research closer to patients through elements like mobile visits and research sites located directly within communities, reducing the burden associated with travel to traditional research study centers. Traditional sites are typically located within large academic medical research campuses in major cities, and 70% of potential trial participants live more than two hours away from their nearest center.  

By reducing travel burdens and making participation more accessible, community-based research helps sponsors accelerate trial enrollment, improve retention, and engage more diverse populations. Adoption has grown significantly: over the past decade, the share of cardiovascular trials incorporating at least one decentralized element has more than doubled from 5% in 2016 to 12.6% in 2025 YTD.

The use of community-based elements are most prevalent in Phase III cardiovascular trials, with 18.5% of new Phase III trials adopting this approach since 2018. This trend also reflects the ambitious recruitment targets of late-stage research, with Phase III CVD studies aiming to enroll around 1,000 patients on average.  

Meanwhile, mobile healthcare is the most common category of decentralized element employed in cardiovascular trials. This category includes mobile visits, where registered nurses or other healthcare professionals meet the patient at their location of choice (typically the patient’s home) to perform the visit. Technology is also playing an increasingly important role in cardiovascular trial protocols. Examples include virtual visits through telemedicine platforms and wearable devices that track outcomes such as physical activity and sleep.

Reaching the underrepresented

Age and gender play a critical role in cardiovascular disease. In the US, the Burden of Cardiovascular Disease in the Elderly study found prevalence rates for coronary artery disease, heart failure, stroke, and hypertension at 38% among adults aged 40–59, 73% for those 60–79, and as high as 79% and 86% for men and women over 80, respectively. While the prevalence of CVD is typically higher in men, women face higher mortality rates and worse outcomes following acute cardiovascular events.

Despite these risks, older adults and women remain underrepresented in cardiovascular trials. For example, Khan et al.’s analysis of randomized trials for lipid-lowering therapies found women accounted for just 28.5% of participants, while adults over 65 represented 46.7%.

Racial and ethnic groups with higher cardiovascular risk are also significantly underrepresented in clinical research. In one analysis evaluating racial representation in clinical studies that supported FDA approvals of 24 cardiovascular drugs, Black US residents made up only 2.9% of participants (compared to 83.1% for White US residents). The study also calculated a “participation-to-prevalence” (PPR) ratio, where a value between 0.8 and 1.2 indicates proportional representation to the real-world disease population for that group. For Black/African Americans across all CVD conditions, the PPR was just 0.29, underscoring a severe gap in representation.

Taken together, cardiovascular trials are failing to reach enough of the right patients, raising concerns about whether safety and efficacy data are truly generalizable. While targeted recruitment and site selection strategies have helped address these gaps, the traditional clinical trial model itself remains a major barrier to enrollment and retention. In particular, older adults, women, and individuals from socioeconomically disadvantaged backgrounds often face significant obstacles to site access, from logistical and mobility challenges to time and financial constraints.

Bringing trials into local communities can help reduce these barriers, with data showing that cardiovascular trials incorporating mobile, community, or home-based research activities are more inclusive of older adults. According to GlobalData’s Clinical Trials database, 64.7% of cardiovascular trials with decentralized elements have included older adults since 2018 (an increase from the average of 55.8%).

Putting community research into action

As data demonstrates the need for continued adoption of community research methods in cardiovascular trials, specialized service partners will be critical in helping sponsors integrate these approaches into future studies. EmVenio Clinical Research offers a range of solutions designed to make cardiovascular research more inclusive, efficient, and impactful, from local community research sites and research centers in pre-existing healthcare facilities, to mobile visits and personalized travel and lodging support solutions.

EmVenio’s community research sites can be located within accessible neighborhood settings and community hubs, reducing participation barriers for diverse populations. For patients in rural areas or those with mobility-limiting conditions such as stroke, mobile visits from EmVenio’s mobile research clinicians enable study participation beyond traditional sites.

When visits to the study site are necessary, EmVenio’s Patient Navigator solution provides coordinated travel, lodging, and reimbursement support to enable better trial accessibility, especially for those who might otherwise have been excluded due to mobility or other challenges. The company also operates a growing number of community hospital-based research centers within the Prime Healthcare network, including centers in the greater metropolitan areas of Dallas, Atlanta, Kansas City, and Detroit, with a new facility recently announced in Chicago.

The opportunities to improve patient access in cardiovascular clinical trials are expanding, enabling sponsors to achieve better representation, retention, and data quality. As community research evolves and providers like EmVenio expand their offerings, more inclusive and impactful cardiovascular trials are within reach.

To learn more about implementing community research methods in hybrid trials, download the whitepaper below.