Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes

Study Overview
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Brief Summary
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The purpose of the study is to assess the impact of HeartLogic-guided management on clinical outcomes among patients implanted with an eligible cardiac device.

Detailed Description
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The study is a pragmatic, registry-based, randomized controlled trial. Eligible patients in Denmark will be randomized 1:1 to either HeartLogic-guided management or usual care. During the trial, patients in the HeartLogic arm will be contacted by a designated team at the central trial site in case of any HeartLogic alerts for evaluation and treatment decisions. There will be no mandatory in-person visits scheduled in the trial. HeartLogic alerts will be managed according to a prespecified management guide. Trial data besides alert-related data will be retrieved from the Danish nationwide health registries including baseline information and endpoint data. The control group will receive usual HF care in the Danish health system without the involvement of the central trial site. The study will comply with the standards of the CONSORT statement and the principles of the Declaration of Helsinki.

Official Title
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Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes

Conditions
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Heart Failure

Intervention / Treatment
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* Other: HeartLogic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Implanted with a CRT-D or ICD device that has HeartLogic capability and ability to change HeartLogic enablement per randomization Age ≥18 years 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HeartLogic-guided management<br>HeartLogic alerts will be transmitted to the central site, which will subsequently contact the participant to assess any treatment needs. Treatment needs will be assessed according to current clinical practice guidelines. | Other: HeartLogic<br>* HeartLogic alerts will be managed according to a standardized alert management guide to ensure uniform reactions to HeartLogic alerts.<br>|
| No Intervention: Standard care<br>The control group will receive usual HF care in the Danish health system. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of hospitalization for heart failure or all-cause death (first event) |  | 42 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of hospitalization for heart failure or all-cause death (recurrent events) |  | 42 months | 
| Hospitalization for heart failure (first event) |  | 42 months | 
| All-cause hospitalization |  | 42 months | 
| All-cause mortality |  | 42 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pragmatic, Heart disease, ICD, CRT-D, Pacemaker, Registry, HeartLogic