Can a smartphone app keep heart failure patients out of the hospital?

NCT ID NCT04755816

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing a mobile app designed to help people with heart failure manage their condition after leaving the hospital. The app sends personalized messages about low-sodium food choices and alerts based on daily symptom reports. The trial enrolls 62 adults recently hospitalized for heart failure and compares those who receive the app's tailored interventions with those who get standard educational content. The goal is to see whether the app can reduce deaths, hospital readmissions, and declines in quality of life over 12 weeks.

What this could mean

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

Active substance
a mobile app that delivers tailored dietary and symptom-based messages
What this could lead to
If it works, this could give heart failure patients a simple, phone-based tool to manage their condition and stay out of the hospital.
What could go wrong
This is a small, short trial of 62 people over 12 weeks, so the results may not hold up in larger or longer studies. App-based support may not work for everyone, and some people may not use it as intended.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

62 people

The number who actually took part.

Started

Jun 2021

Finished

May 2023

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: 1. Age 18 years and older at screening 2. Currently admitted or discharged from the hospital within the last 14 days with a diagnosis of acute or acute on chronic decompensated HF. 3. Based on one of the EF criteria (LVEF within 12 months of randomization. BNP or NT-proBNP criteria within 30 days prior to randomization): * Left ventricular ejection fraction (LVEF) ≤ 40%. * LVEF \>40% and BNP \> 175 pg/ml or NT-proBNP \> 700 pg/ml. Thresholds for NT-proBNP and BNP for LVEF \> 40% will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2. 4. Have a personal physician for follow-up 5. A smartphone with a compatible Apple or Android operating system installed and able to download and use ManageHF including accepting all permissions 6. A valid email address 7. Fluent in spoken and written English Exclusion Criteria: 1. Contraindication to recommending a sodium restriction diet 2. Scheduled intervention for primary valvular heart disease will occur during the study period. 3. Cardiac resynchronization therapy (CRT) within 3 months prior to screening or current plan to implant CRT device during the study period. 4. Dialysis 5. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device. 6. Listed status 1, 2 or 3 for heart transplant 7. Implantation of a ventricular assistance device is expected within 3 months after randomization 8. Non-cardiac illness with expected survival of less than 3 months 9. Discharge to a setting other than home 10. Requirement for chronic inotropic therapy (e.g. milrinone, dobutamine) 11. Inability to use Withings devices due to equipment limitations or contraindications 12. Currently pregnant or intend to become pregnant during the study period.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Atlanta VA Health Care System

    Decatur, Georgia, 30033, United States

  • Emory University

    Altanta, Georgia, 30322, United States

  • Henry Ford Hospital System

    Detroit, Michigan, 48202, United States

  • Stanford University

    Stanford, California, 94305, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23284, United States

  • Washington University in St. Louis

    St Louis, Missouri, 63130, United States

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