Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HeartLogic.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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 the study team 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 device-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 study team. The study will comply with the standards of the CONSORT statement and the principles of the Declaration of Helsinki.
Interventions
- Other HeartLogic
HeartLogic alerts will be managed according to a standardized alert management guide to ensure uniform reactions to HeartLogic alerts.
Primary outcome measures
- Composite endpoint of hospitalization for heart failure or all-cause death (first event) [Time frame: 42 months]
Secondary outcome measures (4)
- Composite endpoint of hospitalization for heart failure or all-cause death (recurrent events) [Time frame: 42 months]
- Hospitalization for heart failure (first event) [Time frame: 42 months]
- All-cause hospitalization [Time frame: 42 months]
- All-cause mortality [Time frame: 42 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiol — Hellerup
Publications
- Fussing FH, Davodian LW, Davodian DW, Johansen ND, Kumarathurai P, Modin D, Sattler S, Larroude C, Risum N, Vinther M, Kober L, Rossing K, Ersboll M, Poulsen MK, Logstrup BB, Holm KF, Haugan KJ, Chien C, Claggett B, Solomon S, Fudim M, Hernandez A, Bekfani T, Johansen JB, Nielsen JC, Stolen CM, Biering-Sorensen T. Hemodynamic Changes in Response to GLP-1 Treatment in ICD and CRT Patients: Insights PMID 41990363
Identifiers
NCT: NCT06099158 · DANLOGIC-HF