Actively Recruiting
Observational Study Designed to Detect Decompensation of Congestive Heart Failure (dCHF) Using a Non-Invasive Wearable Device
Led by CHFDX,Inc. · Updated on 2026-03-11
60
Participants Needed
2
Research Sites
42 weeks
Total Duration
On this page
Sponsors
C
CHFDX,Inc.
Lead Sponsor
T
Tampa General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Observational Study Designed to Detect Decompensation of Congestive Heart Failure (dCHF) Using a Non-Invasive Wearable Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Current use of a hemodynamic sensor device
- At least 4 consecutive weeks of stable pulmonary artery pressures at goal
- Access to a personal smartphone with Wi-Fi or cellular service
You will not qualify if you...
- Unable to provide informed consent
- Unable to read or understand English
- Likely to not use the wearable device as required
- Prisoners
- Pregnant females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
USF Office of Clinical Research
Tampa, Florida, United States, 33612
Not Yet Recruiting
2
USF
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
R
Robby Wu, DO
CONTACT
R
Rohitha Moudgal, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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