Non-Invasive Evaluation by the HEMOTAG^TM Recording Device to Tailor Treatment of Acutely Decompensated Heart Failure

Abstract

This study evaluated the clinical utility of the HEMOTAG™ recording device—A non-invasive, wearable system that measures cardiac time intervals (CTIs)—in managing patients with acutely decompensated heart failure (ADHF). The prospective, single-center study enrolled 105 patients, including those hospitalized with ADHF and a control group with non-HF-related conditions. Daily measurements of isovolumetric contraction time (IVCT), a key CTI marker, were collected using the HEMOTAG device and compared with NT-proBNP levels obtained on admission and day 3. Among ADHF patients, IVCT decreased in parallel with NT-proBNP levels, indicating volume status improvement with therapy. In contrast, the control group showed no significant change in IVCT or NT-proBNP. An IVCT ≥ 40 ms demonstrated strong sensitivity and specificity to detect ADHF (NT-proBNP ≥ 1800 pg/mL). These findings suggest that IVCT trends measured by HEMOTAG correlate with short-term treatment response in ADHF and could offer a non-invasive method to guide heart failure management. The technology demonstrated feasibility, safety, and clinical relevance, supporting its potential role in future remote management strategies.

Keywords

Heart failure / Acutely decompensated heart failure (ADHF) / Isovolumetric contraction time (IVCT) / NT-proBNP / Cardiac time intervals (CTIs) / Remote management / Wearable device / Non-invasive monitoring / Congestion

Acknowledgments

The authors gratefully acknowledge support from Aventusoft LLC for the HEMOTAG technology and funding from the National Heart, Lung, And Blood Institute under grant number R44HL145941.

Author Contributions

Conceptualization, R.C., F.R.T., J.E.P., D.U. and D.S.; Methodology, R.C., F.R.T., J.E.P., D.U. and D.S.; Software, R.C., F.R.T. and J.E.P.; Validation, R.C., F.R.T., J.E.P., D.U. and D.S.; Formal Analysis, D.U. and D.S.; Investigation, R.C., F.R.T., J.E.P., D.U. and D.S.; Resources, D.S.; Data Curation, D.U. and D.S.; Writing—Original Draft Preparation, R.C., F.R.T., J.E.P., D.U. and D.S.; Writing—Review & Editing, R.C., F.R.T., J.E.P., D.U. and D.S.; Visualization, R.C., F.R.T., J.E.P., D.U. and D.S.; Supervision, D.S.; Project Administration, D.S.; Funding Acquisition, D.S.

Ethics Statement

The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Institutional Review Board of University of Miami (Study Protocol: 20190420, date of approval: 6/30/2019).

Informed Consent Statement

Informed consent was obtained from all subjects involved in the study.

Data Availability Statement

The data is protected as per the guidelines of SBIR data protection from for a period of not less than 20 years with the protection period beginning at the time of the Phase award (R44HL145941 - 06/01/2019).

Funding

This research was funded by the National Heart, Lung, And Blood Institute grant number R44HL145941.

Declaration of Competing Interest

The authors declare no conflict of interest.

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