RecruitingNCT07350759

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

An Observational Study to Develop an Algorithm to Predict Decompensation of Congestive Heart Failure (dCHF) Using a Non-Invasive Wearable Device.


Sponsor

CHFDX,Inc.

Enrollment

60 participants

Start Date

Mar 9, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a non-invasive wearable device can detect early signs that heart failure is getting worse (called decompensation) in people who are already being monitored with an implanted pressure sensor in their heart. The goal is to add a wearable layer of monitoring that could catch problems even earlier and without an invasive implant. **You may be eligible if...** - You are 18 or older - You already have an implanted device that monitors your heart's blood pressure (hemodynamic sensor) - Your heart pressures have been stable for at least 4 consecutive weeks - You have a smartphone with Wi-Fi or cellular access **You may NOT be eligible if...** - You cannot give informed consent - You cannot read or understand English - You are unlikely to wear the device consistently - You are a prisoner - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEwearable 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.


Locations(2)

USF Office of Clinical Research

Tampa, Florida, United States

USF

Tampa, Florida, United States

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NCT07350759