Clinical Trial

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

Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-09.
Status change: Not Yet Recruiting → Recruiting 2026-03-09
Trial Details
NCT Number NCT07350759
Lead Sponsor CHFDX,Inc.
Collaborators: Tampa General Hospital, University of South Florida
Conditions Decompensated Chronic Heart Failure
Enrollment 60 participants
Start Date 2026-03-09
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-11