Recruiting

Observational Study

Sponsor:

CHFDX,Inc.

Code:

NCT07350759

Conditions

Decompensated Chronic Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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.

Conditions

Decompensated Chronic Heart Failure

Study ID

NCT07350759

Start date

Mar 9, 2026

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with congestive heart failure

Patients will be monitored by a a tiny, battery-free pressure sensor implanted in a branch of the pulmonary artery via a right-heart catheterization, previously placed for a history of decompensating heart failure.

Interventions

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

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.

Primary outcome measure

  • Changes in multiple physiologic parameters from baseline that correlate with onset of dCHF [ Time Frame: Up to 12 Months ]

Central Contacts and Locations

Central contacts

Robby Wu, DO

813-844-7000Robbywu@usf.edu

Rohitha Moudgal, MD

813-844-7000rohitamoudgal@usf.edu

Locations

USF

Recruiting

Tampa, Florida, United States, 33612

Contacts

Robby Wu MD, MD

813-844-7000robbywu@usf.edu

More Information

Sponsor

CHFDX,Inc.

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • congestive heart failure
  • wearable monitor
  • predictive algrothim

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CHFDX,Inc. on 2026-03-11.