Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06099158

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Hellerup, Capital Region, 2900, Denmark

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HeartLogic

Other

HeartLogic alerts will be managed according to a standardized alert management guide to ensure uniform reactions to HeartLogic alerts.

Primary outcomes

  1. Composite endpoint of hospitalization for heart failure or all-cause death (first event)

    Time frame: 42 months

Secondary outcomes

  1. Composite endpoint of hospitalization for heart failure or all-cause death (recurrent events)

    Time frame: 42 months

  2. Hospitalization for heart failure (first event)

    Time frame: 42 months

  3. All-cause hospitalization

    Time frame: 42 months

  4. All-cause mortality

    Time frame: 42 months

Other outcomes

  1. Hospitalizations for heart failure (recurrent events)

    Time frame: 42 months

  2. Hierarchical composite of all-cause mortality, total number of heart failure hospitalizations, and total number of all-cause hospitalizations

    Time frame: 42 months

  3. All-cause readmission within 30 days after hospitalization for heart failure

    Time frame: 42 months

  4. Hospitalization for any cardiovascular disease

    Time frame: 42 months

  5. Hospitalization for any cardio-respiratory disease

    Time frame: 42 months

  6. Hospitalization for atrial fibrillation

    Time frame: 42 months

  7. Atrial fibrillation burden

    Time frame: 42 months

  8. Hospitalization for cardiac arrest

    Time frame: 42 months

  9. Ventricular tachyarrhythmia leading to anti-tachycardia pacing and/or shock

    Time frame: 42 months

  10. Cardiovascular mortality

    Time frame: 42 months

  11. Incident heart failure (among participants without heart failure at baseline)

    Time frame: 42 months

  12. Days alive and out of hospital

    Time frame: 42 months

  13. Length of hospital stay

    Time frame: 42 months

  14. Use of guideline-directed medical therapy for heart failure

    Time frame: 42 months

  15. HeartLogic alert rate

    Time frame: 42 months

  16. Average HeartLogic index

    Time frame: 42 months

  17. Median HeartLogic alert length

    Time frame: 42 months

  18. % time in HeartLogic alert

    Time frame: 42 months

  19. Maximal observed HeartLogic index

    Time frame: 42 months

  20. Time from HeartLogic alert to clinical event

    Time frame: 42 months

  21. Individual HeartLogic sensor trends

    Time frame: 42 months

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Tor Biering-Sørensen

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Acronym: DANLOGIC-HF

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 25, 2023
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.