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

Recruitingn/aAges 18 Years - anyAllCHFDX,Inc.
NCT07350759 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * • Age ≥ 18 years * Current use of a hemodynamic sensoring device * At least 4 consecutive weeks of stabilized "goal" pulmonary artery pressures * Access to a personal smartphone with Wi-Fi or cellular connectivity Exclusion Criteria: * • Inability to provide informed consent * Inability to read or understand English * Likely non-adherence to wearable device use * Prisoners * Pregnant females
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What it tests

  • 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
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Where

2 sites
USF Office of Clinical Research
Tampa, United States
USF
Tampa, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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