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

Recruiting now

Conditions studied: Decompensated Chronic Heart Failure

In brief

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.

Key facts

Study ID

NCT07350759

Run by

CHFDX,Inc.

People needed

60

Starts

2026-03-09

Expected to finish

2026-12-31

Last updated by the study team

2026-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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

You may not qualify if…

• • Inability to provide informed consent
• Inability to read or understand English
• Likely non-adherence to wearable device use
• Prisoners
• Pregnant females

Where it is running

• USF — Tampa, Florida, United States (enrolling)
• USF Office of Clinical Research — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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