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Observational Study for Decompensated Congestive Heart Failure Using a Wearable Device

This study is looking for people with chronic heart failure that has worsened (decompensated chronic heart failure, or dCHF). It aims to find out if a wearable ring device can predict when your heart failure might get worse. You would wear a special ring that continuously collects data like your heart rate, sleep, and activity. Researchers will compare this data with information from your existing heart monitor to see if there are patterns that signal a future worsening of heart failure. The goal is to develop a mathematical tool to help predict these events. This study is for adults aged 18 and older who already use a heart monitor and have a smartphone.

Study design
This is an observational study involving 60 participants. It is designed to develop a mathematical algorithm to predict heart failure decompensation.
What's involved
You would wear a wearable ring device continuously for up to 12 months. You may also choose to provide optional biospecimen (DNA, blood, urine) and weekly voice samples.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for a minimum of 6 months and up to 12 months, with primary endpoints measured at up to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07350759

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

Recruiting
Not specifiedAges 18+Observational
CHFDX,Inc.
~60 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested: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

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in multiple physiologic parameters from baseline that correlate with onset of dCHF
Measured over Up to 12 Months

Conditions

Decompensated Chronic Heart Failure

Explore related trials

Congestive Heart Failure

Where it's being run

2 sites across 1 states
Florida2

Study leadership

  • Wu, DO · PRINCIPAL_INVESTIGATOR · Tampa General Hospital

Who to contact

Robby Wu, DO
[email protected]
813-844-7000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

• 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

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

What this trial measures

  • Changes in multiple physiologic parameters from baseline that correlate with onset of dCHFUp to 12 Months

    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.