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

RECRUITINGSponsored by CHFDX,Inc.
Actively Recruiting
SponsorCHFDX,Inc.
Started2026-03-09
Est. completion2026-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →

NCT07350759

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Decompensated Chronic Heart FailureHeart Disease

Locations2 sites

USF Office of Clinical Research
Tampa, Florida, 33612
USF
Tampa, Florida, 33612
Robby Wu MD, MD813-844-7000robbywu@usf.edu

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