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NCT07350759Recruiting

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.

Source: ClinicalTrials.gov · Last updated 11 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
60 (estimated)
First submitted
25 Dec 2025
Start date
9 Mar 2026
Primary completion date
31 Dec 2026
Lead sponsor
CHFDX,Inc.
NCT number
NCT07350759

What you commit to

  • Study type: Observational
  • Planned participants: 60
  • From 9 Mar 2026 to the primary completion date, 31 Dec 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
USF Office of Clinical Research
Coordinator of this site? Confirm its status
TampaUnited StatesNot yet recruiting
USF
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.