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Observational Study Designed to Detect Decompensation of Congestive Heart Failure (dCHF) Using a Non-Invasive Wearable Device

NCT07350759 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-03-11

No results posted yet for this study

Summary

This is a prospective, observational pilot study designed to develop a mathematical algorithm capable of predicting decompensation of congestive heart failure (dCHF) using physiologic data collected from a non-invasive wearable device. Participants with a remote hemodynamic pulmonary artery pressure monitor will wear a wearable device continuously for up to 12 months. Wearable data will be analyzed in relation to the hemodynamic monitor defined sentinel events of heart failure decompensation to identify predictive signal patterns. Optional biospecimen (DNA, blood, urine) and voice sample collection will support future biomarker discovery.

Conditions

  • Decompensated Chronic Heart Failure

Interventions

DEVICE

wearable ring device with multiple embedded sensors to detect heart rate, SVO2, respiratory rate, heart rate variability and a number of other related physiologic parameters

In this observational study, a non-invasive, wearable ring used for continuous passive collection of physiologic data (sleep, activity, heart rate, HRV, temperature) will be used to collect data from all patients in the study. Data are used solely for research and algorithm development and are not used for diagnosis or treatment.

Sponsors & Collaborators

  • Tampa General Hospital

    collaborator OTHER

  • University of South Florida

    collaborator OTHER

  • CHFDX,Inc.

    lead INDUSTRY

Principal Investigators

  • Wu, DO · Tampa General Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-09
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07350759 on ClinicalTrials.gov