Smart device alerts aim to cut heart failure hospitalizations
NCT ID NCT06099158
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether using alerts from a heart device (HeartLogic) can help manage heart failure better. About 1,428 adults with a compatible implanted device will be randomly assigned to have their care guided by these alerts or not. The goal is to see if this approach reduces hospitalizations for heart failure or death.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HeartLogic alert management (a software feature in implanted cardiac devices that provides alerts to guide heart failure care)
- What this could lead to
- If it works, this could provide a better way to manage heart failure using device alerts, potentially reducing hospital stays and improving survival.
- What could go wrong
- This is a pragmatic trial, so results may vary in real-world settings. The intervention is a monitoring tool, not a treatment, so benefits may be modest or not apply to all patients.
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
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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
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About 1,428 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- 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. Implanted with a CRT-D or ICD device that has HeartLogic capability and ability to change HeartLogic enablement per randomization 2. Age ≥18 years 3. Compliant with remote monitoring and not listed in the LATITUDE™ remote monitoring system as "not monitored" Exclusion Criteria: There are no specific exclusion criteria for the trial.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
RECRUITINGHellerup, Capital Region, 2900, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can daily mindful breathing ease heart failure symptoms?
- Can a smartphone app keep heart failure patients out of the hospital?
- Can better training get doctors to talk about what matters most to dying veterans?
- Can AI read heart ultrasounds as well as trained sonographers?
- Can modern heart failure drugs reverse damage in three months?