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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCHFDX,Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

• 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

Disqualifiers

• Inability to provide informed consent

Inability to read or understand English

Likely non-adherence to wearable device use

Prisoners

Trial population

University of South Florida Tampa General Hospital

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

    Device

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Patients with congestive heart failure1 intervention

Trial outcomes

Primary outcomes

1

Changes in multiple physiologic parameters from baseline that correlate with onset of dCHF

Identification of reproducible changes in wearable physiologic data that occur in the 1-7 days preceding a hemodynamic monitoring device detection of elevated pulmonary artery pressure sustained over 2 days defined as a sentinel event of decompensated CHF.

Time frame
Up to 12 Months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CHFDX,Inc.

Lead sponsor

Tampa General Hospital

Collaborator

University of South Florida

Collaborator