Breakthrough Multicentered Study will Evaluate Efficacy of Digital Health Data Collection Outside the Clinic for Guideline-Directed Heart Failure Therapy
Datos Health, a leader in remote care automation, today announced its collaboration with Amgen, one of the world’s leading independent biotechnology companies, on a new study to evaluate the potential impact of digital health data to improve therapy in heart failure.
The initiative has been successfully launched in seven leading U.S. teaching hospitals and continues to enroll new patients. Leveraging Datos’ remote care automation platform to remotely collect health data, it will serve as a basis for comparing guideline-directed heart failure therapy utilizing digital health data with traditional practices that do not employ digital resources.
“This breakthrough study will test the hypothesis that remotely collected patient data – such as heart rate and blood pressure indicators – measured asynchronously through digital technologies can facilitate better, personalized titration of guideline-recommended heart failure medications,” said Akshay S. Desai, M.D., Associate Professor, Harvard Medical School, who is co-chairing the study, together with Mitchell Psotka, M.D., Ph.D., Section Chief, Inova Heart and Vascular Institute.
“Utilization of digital health data for investigators can lead to earlier initiation, up-titration, or determination of end-of-dose adjustments for guideline-based heart failure therapies and achieve optimal tolerated doses for individual therapies. Datos’ speed of implementation and ease of protocol configuration to integrate clinically relevant real-time health information makes it an ideal partner for this research,” added Dr. Psotka.
Heart failure treatment is becoming increasingly complex, often requiring prescription of multiple medications in conjunction with lifestyle changes. Despite overwhelming evidence of the effectiveness of heart failure medications, adoption of these therapies is often poor. A recent study showed that significant gaps in use and dose of guideline-directed medical therapy remain and the authors concluded that strategies to improve guideline-directed use of HFrEF medications remain urgently needed (J Am Coll Cardiol 2018;72:351–66). Often heart failure therapy doses are not titrated to the doses tested in trials or doses may be limited by a fear of adverse reactions, including blood pressure and heart rate. A key challenge may be efficient and cost-effective monitoring of patient response to these evidence-based and guideline-directed treatments to achieve optimal therapy and improve patient adherence. Today, patients are usually only checked during periodic visits to clinics. The shift to digitally-enabled remote data collection enables continuous monitoring of patients’ vitals – including blood pressure, heart rate and daily physical activity – which may accelerate or otherwise enhance treatment decisions. Remote data collection can also provide a decision support tool to enable timely treatment changes.
“Datos is committed to supporting pharmaceutical companies in accessing and validating the data essential to enable timely interventions and increase patient adherence to treatment guidelines, freeing them up to devote greater energies to furthering development and testing,” said Uri Bettesh, CEO and Founder of Datos Health. “We are delighted to collaborate with Amgen to study the benefits of leveraging digital solutions like Datos’ remote care platform to optimize cardiac care.”