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Heart failure wearable trial fizzles: only 15 enrolled before shutdown

NCT ID NCT05988749

Disease control Sponsor: University of Texas Southwestern Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a wearable device and digital care plan from the American Heart Association could help people with systolic heart failure. Participants wore the device for 90 days while their care team monitored their data. The trial was terminated early and only enrolled 15 out of a planned 150 participants, so we cannot draw firm conclusions.

What this could mean

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

Active substance
Biofourmis Digital Platform with AHA Heart Failure CarePlans
What this could lead to
If successful, this approach could help doctors better manage heart failure patients remotely, potentially reducing hospital stays and improving medication use.
What could go wrong
The trial was terminated early and enrolled only 15 people, so results are very limited. It is unclear if the intervention works or is practical for wider use.

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

15 people

The number who actually took part.

Started

Dec 2024

Finished

Nov 2025

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: * ≥18-year-old adults with a clinical diagnosis of heart failure AND a left ventricular ejection fraction ≤40% by transthoracic echocardiogram or cardiac MRI within 12 months prior to enrollment. Exclusion Criteria: * Patients who are pregnant. * Patients who do not have a smartphone or access to the Internet * Prisoners or refugees. * Patients who are homeless or have unstable housing. * Unable or unwilling to consent or use study related materials. * On-going cocaine, methamphetamine, opioid, alcohol, or other illicit substance abuse as determined by the study PI. * Not fluent in English or Spanish. * Students or trainees at UT-Southwestern or Parkland Health System. * Enrolled or considering hospice. * Recent or home inotropic therapy, or heart transplant evaluation. * Survival anticipated \<6 months. * End-stage renal disease, receiving dialysis or eGFR ≤30 mL/min/1.73m2 * Non-Texas resident

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Conditions

The condition(s) this trial relates to.

heart failure systolic heart failure

As listed by the trial registrant

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

Heart failure, systolic

Contacts and locations

Locations

  • Parkland Health & Hospital System

    Dallas, Texas, 75235, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

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