Evaluating HeartLogic Management for Heart Failure Outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study assesses the impact of HeartLogic-guided management on clinical outcomes in patients with heart failure who have an implanted cardiac device. It is a pragmatic, registry-based, randomized controlled trial conducted in Denmark, where eligible patients will be randomly assigned to either HeartLogic-guided management or usual care. Patients in the HeartLogic group will receive alerts for evaluation and treatment decisions without mandatory in-person visits, while the control group will follow standard heart failure care. Data will be collected from nationwide health registries to evaluate the effectiveness of the intervention.

Why it matters

Who can join: the full rules

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.

Where it's running

• Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
  Hellerup, Capital Region, Denmark Recruiting
• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Rigshospitalet
  Copenhagen, Denmark Recruiting
• Odense University Hospital
  Odense, Denmark Recruiting
• Zealand University Hospital
  Roskilde, Denmark Recruiting

Study contacts

• Study coordinator: Frederik Holme Fussing, MD
• Email: frederik.holme.fussing@regionh.dk
• Phone: +4521547157

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.