Evaluating HeartLogic Management for Heart Failure Outcomes
Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
This study tests if using HeartLogic technology to manage heart failure can help patients with implanted devices do better compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1428 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev and Gentofte Hospital Academic / other |
| Locations | 1 site (Hellerup, Capital Region) |
| Trial ID | NCT06099158 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have an implanted CRT-D or ICD device with HeartLogic capability.
Not a fit: Patients who are not compliant with remote monitoring or are not using a device with HeartLogic capability may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved heart failure management and outcomes for patients with cardiac devices.
How similar studies have performed: Other studies have shown promise in using remote monitoring for heart failure management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hellerup, Capital Region
- Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte — Hellerup, Capital Region, Denmark (Recruiting)
Study contacts
- Study coordinator: Niklas Dyrby Johansen, MD
- Email: niklas.dyrby.johansen@regionh.dk
- Phone: +4520204794
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.