Can a smartphone app keep heart failure patients out of the hospital?
NCT ID NCT04755816
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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62 people
The number who actually took part.
- Started
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Jun 2021
- Finished
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May 2023
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Atlanta VA Health Care System
Decatur, Georgia, 30033, United States
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Emory University
Altanta, Georgia, 30322, United States
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Henry Ford Hospital System
Detroit, Michigan, 48202, United States
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Stanford University
Stanford, California, 94305, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
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Virginia Commonwealth University
Richmond, Virginia, 23284, United States
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Washington University in St. Louis
St Louis, Missouri, 63130, United States
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