Cardiovascular (CV) disease represents the leading cause of death globally, taking nearly 18 million lives every year and making research to protect heart health a top priority for drug developers worldwide.1 Whether examining new treatments for CV conditions or determining the CV impact of drugs intended for other indications, CV studies have a vital role in drug development and global health.
Over the years, invaluable tools have evolved to facilitate and enhance CV studies. In particular, digital health technologies (DHTs), which employ connectivity, software, computing platforms or sensors for healthcare related uses, are a rapidly advancing tool that CV studies can leverage to their advantage. This blog explores the DHTs that are particularly relevant to CV measures, as well as how their utility in data capture and patient centricity can benefit CV studies.
DHTs applicable to CV studies
DHTs encompass a wide range of tools, from mobile apps to digitally connected health equipment. Some DHTs, such as telehealth or software that enables electronic patient-reported outcomes, are broadly beneficial to streamlining and improving clinical studies, regardless of indication. However, there are many DHTs with capabilities that have applications specifically designed to meet the needs of CV studies, providing much of the data that site visits typically capture — for instance, heart rhythm and vital signs. These tools can gather important safety and efficacy data, and even collect digital endpoints.
Biosensor technology can be deployed in various forms, from patches that collect vital signs over 30 days to wearables that track physical activity, blood pressure, heart rate and electrocardiogram (ECG) tracings. Even common consumer wearable devices have proven useful in CV studies. For example, Fitbits — wearables designed to track fitness and health-related metrics — were used in the CHIEF-HF trial to measure physical activity through accelerometry as a key secondary endpoint, demonstrating that the heart failure medication canagliflozin rapidly improved symptoms and function.2
Additionally, various mobile and digitally connected ECG devices have been developed to measure the heart’s electrical activity outside clinical settings. These range from vests that can continuously collect ECG for 30 days, to simple rhythm strips, to patches that capture single or multiple-lead ECG data.
Enhancing efficiency with data capture
Leveraging DHTs enables the collection of more complete, high quality real-world data than infrequent site visits from participants. Rather than only collecting data at a few, specific time points, DHTs can provide more frequent and comprehensive, even continuous, data collection, filling gaps and offering a fuller picture of participant health.
For instance, ambulatory blood pressure monitoring collects data over a 24-hour period, traditionally using a portable blood pressure cuff, though new technologies, such as watch-like sensors, are emerging. By capturing data throughout a patient’s day, and even while a patient is sleeping, this method enables a better assessment of variability in blood pressure. Additionally, some studies have shown that ambulatory blood pressure data better correlates with cardiovascular outcomes than office based monitoring does.3
With the analysis of the data they provide, DHTs can even help researchers uncover patterns and nuances in participant health over time that might have been missed by traditional site visits. And this improved level of insight can be enhanced when DHTs are used in combination with clinical outcome assessments, combining active and passive data collection to provide a more complete understanding of participants’ health status and treatment effects.
Further, the reduced need for site visits allows the simplification of study protocols, making studies more efficient. Fewer site visits means lower patient burden and a reduced need for study staff onsite, and the visits that remain are likely to involve fewer tests and procedures. For instance, if a patient uses a mobile ECG device for a month, there may be little need to conduct an ECG during their site visit.
Improving CV studies through patient centricity
A key benefit of DHTs is their utility in enabling decentralised and hybrid clinical trials. Because the digital collection of study data through DHTs requires few site visits, or even none at all, it also reduces participant burden, such as travel and time off work. In this way, DHTs can improve the accessibility of CV studies for a variety of patients, including those with limited mobility and those in disadvantaged or rural geographies. This, in turn, benefits the study overall, with improved retention and a broader potential population from which to recruit.
Adherence to medication and study protocols is critical for the validity of CV studies and for achieving better patient outcomes. However, patient adherence to CV treatment is often low, with factors such as forgetfulness, low motivation and low health literacy contributing to nonadherence. The use of DHTs, such as text messaging, apps and telehealth, can help keep patients more engaged in a study and increase adherence.
While planning for employing DHTs in a CV study, it is important to consider their impact on participants. The ideal is to employ digital tools that take little effort from study participants, with passive data collection when possible, to minimise disruptions to participants’ lives, as well as the dataflow. Any interfaces should be simple and convenient to use, and participants should receive the necessary support in learning to use tools and make them part of everyday life. Overall, the simpler and easier it is for patients to use DHTs, the better the results will be.
Leveraging a critical tool
Improving on CV studies — from enhancing efficiency to increasing patient recruitment, retention and engagement — is critical to continuing efforts to protect and advance heart health. DHTs can be a powerful tool in achieving these goals. With the strategic application of DHTs, researchers can accomplish more than was possible through traditional methods. And these possibilities will only expand as DHTs continue to advance.
References:
1 Cardiovascular Diseases. https://www.who.int/health-topics/cardiovascular-diseases. Accessed 25 Aug. 2025.
2 Spertus, John A., et al. “The SGLT2 Inhibitor Canagliflozin in Heart Failure: The CHIEF-HF Remote, Patient-Centered Randomized Trial.” Nature Medicine, vol. 28, no. 4, Apr. 2022, pp. 809–13, https://doi.org/10.1038/s41591-022-01703-8.
3 Grossman, Ehud. “Ambulatory Blood Pressure Monitoring in the Diagnosis and Management of Hypertension.” Diabetes Care, vol. 36, no. Suppl 2, Aug. 2013, pp. S307–11, https://doi.org/10.2337/dcS13-2039.
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