In collaboration with the FDA and Biofourmis, Biovotion's Everion will play a critical role in a new trial aimed at improving outcomes and evaluating new endpoints for heart failure patients. Leveraging Biofourmis' AI-enabled platform, BiovitalsHF, data collected from discharged patients will be used to develop new methods of evaluating the efficacy of heart failure drugs. For more information see the IDTechEx report on Wearable Technology Forecasts 2019-2029.
This trial is one of a new breed of clinical trials which showcase the potential of patient-centered research, taking advantage of portable and comfortable medical-grade wearables and innovative big-data platforms. The trial takes place at the Yale University-Mayo Clinic Center for Excellence in Regulatory Science and Innovation, which partners with the FDA to "create infrastructure for regulatory science knowledge generation, conduct research to address key gaps in knowledge, and develop tools to support regulatory decision-making and the overall mission of the FDA".
A major goal of this trial is to collaborate physiological biomarkers with endpoints, and corollate them to patient-reported quality of life measures. In a statement, Biofourmis' founder Kuldeep Singh Rajput elaborates : "Heart failure is a highly prevalent disease that not only carries high morbidity, but also significantly lowers a patient's quality of life. While hard outcomes such as mortality and hospitalization rates have served as the traditional endpoints in clinical studies, we also should take into consideration the patients' levels of satisfaction and well-being while being treated with a heart failure drug during a trial. Not only is quality of life important in a disease such as heart failure, but patient-centric endpoints can be identified much more quickly than traditional hard outcomes."
The trial will also measure biomarkers derived from physiology and actiography to look for a correlation to gold-standard clinical endpoints: lab results, the six-minute walk test, and the Kansas City Cardiomyopathy Questionnaire. Other measures collected will include medication adherence, dose changes, and the percentage of patients on target dosages of Guideline Directed Heart Failure Therapies.
Heart failure is a major cause of mortality around the world and affects nearly 3% of the US population. Evaluating the efficacy of drugs to treat heart failure is a cornerstone of the clinical trials landscape, yet many drug makers have been unable to tie their drugs to a substantive improvement in quality of life. One key strength of the Biovitals HF platform is its ability to detect heart failure decompensation weeks in advance. Pair that with the leading clinically validated, CE-marked biosensor Everion, and the possibilities for improving patient outcomes drastically expand. The trial is set to begin in August 2019. Biovotion is excited to be part of such a groundbreaking study.
Biovotion's Everion combines an unrivalled number of precise sensors in one single platform, with a form factor that is very comfortable to wear for long periods. There are no buttons and it is comfortable to wear on the upper arm, where it collects real time data, continuously. The Everion provides 22 parameters and features. The vital sign parameters mirror what would be collected in a low-acuity environment in a clinical setting (heart rate, skin temperature, respiratory rate, blood oxygenation). Additional clinical and non-clinical parameters (blood pulse wave, activity and steps, energy expenditure, sleep, heart rate variability , Inter-beat-interval & stress) give supplemental value added insights. The platform is expandable & new parameters will be added, covering an even wider spectrum of measurements.
Source and top image: Biovotion