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

NCT06099158 | Recruiting

• 1 other identifier: DANLOGIC-HF
• Study Type: interventional
• Target: 1,428
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

Pragmatic; Heart disease; ICD; CRT-D; Pacemaker; Registry; HeartLogic

Outcome Measures

Primary Outcomes (1)

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

  42 months

Secondary Outcomes (4)

• 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

Other Outcomes (21)

• Hospitalizations for heart failure (recurrent events)

  42 months

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

  42 months

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

  42 months

Study Arms (2)

HeartLogic-guided management

EXPERIMENTAL

HeartLogic alerts will be transmitted to the study team, which will subsequently contact the participant to assess any treatment needs. Treatment needs will be assessed according to current clinical practice guidelines.

Other: HeartLogic

Standard care

NO INTERVENTION

The control group will receive usual HF care in the Danish health system.

Interventions

HeartLogic OTHER

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

HeartLogic-guided management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

Sponsors & Collaborators

• Tor Biering-Sørensen: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

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

Hellerup, Capital Region, 2900, Denmark

RECRUITING

MeSH Terms

Conditions

Heart Failure; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Tor Biering-Sørensen, MD, MSc, MPH, PhD

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

  STUDY CHAIR

Central Study Contacts

Niklas Dyrby Johansen, MD

CONTACT

+4520204794; niklas.dyrby.johansen@regionh.dk

Marie Terese Barlebo Madsen, PhD

CONTACT

+4553377345; marie.terese.barlebo.madsen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to treatment allocation. Active-arm participants will be unblinded at the time of first HeartLogic alert.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, MSc, MPH, PhD, MP

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 25, 2023
• Study Start: May 31, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)