SAN FRANCISCO, May 18, 2023 /PRNewswire/ – Bodyport Inc. today introduced SCALE-HF, a multi-phase study to develop and validate a composite index to predict heart failure events using multiple noninvasive hemodynamic biomarkers gathered when a patient stands on the Bodyport Cardiac Scale. An article published in the May 2023 issue of the journal Circulation: Heart Failure describes the design of the prospective, multicenter study, which will assess the accuracy of the Heart Function Index (HFI), a novel algorithm created to help care teams remotely monitor, predict, and prevent worsening heart failure events.
“There are more than 6 million Americans living with heart failure, and the current standard of care for monitoring the majority is having them weigh themselves daily to identify fluid buildup, a key indicator of worsening heart failure. But weight gain alone is not a sensitive signal for fluid overload, and by the time it’s detected, it’s often too late to prevent cardiac events that negatively impact health and lead to hospitalization,” said Adam DeVore, MD, MHS, cardiologist, and associate professor of medicine at Duke University School of Medicine, member of the Duke Clinical Research Institute, and SCALE-HF principal investigator. “What’s needed is not only a measurement method that’s as simple and noninvasive for patients to use as a weight scale, but one combined with an analysis sensitive enough to identify issues early, so care teams can intervene as early as possible. That’s what we’re assessing in this study of the Heart Function Index.”
Worsening heart failure is a major cause of patient morbidity and mortality, and with a high rate of hospitalization and readmission, there is a clear need to stem disease progression and reduce costs associated with preventable hospitalizations. With approximately 90% of hospitalizations attributed to hypervolemia or fluid overload, the need for earlier identification of hemodynamic changes and fluid accumulation and, ultimately, stronger predictive capabilities are what led to the development of the HFI and Cardiac Scale by Bodyport, the sponsor of SCALE-HF.
Like a conventional weight scale, daily use of the Cardiac Scale involves a patient standing barefoot on its surface for 20 to 30 seconds. With weight included among the scale’s biomarkers, the noninvasive biosensors built into the Cardiac Scale’s platform measure several FDA-cleared biomarkers of heart function and fluid status that accurately reflect worsening heart failure. The data are then transmitted via cellular technology and paired with the care team’s clinical dashboard so they can remotely assess them within their existing workflows and provide medical intervention as needed. The same data also inform insights provided by a user-friendly app that encourages patients to track their health, stay on treatment, and develop new behaviors that may slow the progression of heart failure.
The scale’s biomarkers are being used in the SCALE-HF study to develop the algorithm used in the Heart Function Index and assess its accuracy, with Bodyport anticipating that HFI’s predictive capabilities will ultimately compete with currently used technologies that are accurate but also very invasive.
“Existing technologies that can detect the signs of worsening heart failure require an invasive implant, are narrowly indicated, and are expensive,” said Corey Centen, founder, President, and Chief Technical Officer at Bodyport. “Our aim is to leverage the simple and familiar practice of stepping on a scale that is already part of patients’ daily routine and augment it with the precision and predictive power of noninvasive hemodynamic biomarkers.”
The article in this month’s Circulation: Heart Failure describes the approach and the methodology for developing the HFI algorithm, which has been the focus of phase 1 of the SCALE-HF study. Phase 2 of the study will focus on the validation of the HFI algorithm and provide the pivotal data Bodyport needs for FDA clearance of the HFI. Currently, the Bodyport Cardiac Scale is indicated for the non-invasive monitoring and management of patients with fluid management related health conditions.
