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Can a wearable predict heart failure Flare-Ups before they happen?

NCT ID NCT06007079

Knowledge-focused Sponsor: Analog Device, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This study is testing a wearable monitoring device designed for people with chronic heart failure to use at home. The device collects physiological data daily for five months, and researchers will then compare that data with any heart failure events, like hospitalizations or worsening symptoms, that occur during a follow-up period. The goal is to see if the device's measurements can help predict these events, which could inform the design of a future, larger study. Clinicians will not see the device data during the study, so it won't influence their treatment decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A wearable monitoring device (CardioPulmonary Management System) that tracks physiological data in the home setting.
What this could lead to
If successful, this could lead to a home-based monitoring system that helps predict heart failure events, potentially enabling earlier intervention and better management.
What could go wrong
This is a very small, early-stage study (only 2 participants) focused on data collection, not treatment. The device's ability to predict events is unproven, and results may not apply to broader populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

2 people

The number who actually took part.

Started

Dec 2023

Finished

Oct 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Heart failure patients regardless of ejection fraction (HFpEF or HFrEF) with one or more of the following: * NYHA Class III-IV * NYHA Class II HF with one or more of the following: * Chronic Kidney Disease (eGFR\<60) * HF hospitalization (defined as HF listed as the major reason for hospitalization) within 9 months prior to screening visit and NT-proBNP \> 200 pg/ml for patients not in AF or \> 600 pg/m for patients in AF on screening ECG * NT-proBNP \> 300 pg/ml for patients not in AF or \> 900 pg/ml for patients in AF on the screening visit ECG. * Chronic obstructive pulmonary disease (COPD) Exclusion Criteria: * Under 18 years of age * Patients with severe COPD (GOLD stage III or IV) * Chronic Kidney Disease (eGFR \< 20) * Limited mobility preventing application of device * Cognitive impairments that would limit the application and proper use of the device * Skin allergies or skin sensitivities to silicone-based adhesives * Pregnancy * Skin breakdown on the left chest or breast area * Not willing to shave chest hair if needed to apply device * Patients on chronic inotropic therapy * Patients with any condition that might limit the survival to less than 1 year as assessed by the investigator * No cellular coverage (Patient's Home)

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Conditions

The condition(s) this trial relates to.

congestive heart failure heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

Contacts and locations

Locations

  • Columbia University Medical Center

    New York, New York, 10032, United States

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