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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: HeartLogic

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.

• Study Type: Interventional
• Enrollment (Estimated): 1428
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Niklas Dyrby Johansen, MD; Phone Number: +4520204794; Email: niklas.dyrby.johansen@regionh.dk
• Study Contact Backup: Name: Marie Terese Barlebo Madsen, PhD; Phone Number: +4553377345; Email: marie.terese.barlebo.madsen@regionh.dk

Study Locations

• Denmark
  • Capital Region
    • Hellerup, Capital Region, Denmark, 2900
      • Recruiting
      • Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
      • Contact: Niklas Dyrby Johansen, MD; Phone Number: +4520204794; Email: niklas.dyrby.johansen@regionh.dk
      • Principal Investigator: Tor Biering-Sørensen, MD, MSc, MPH, PhD
      • Contact: Marie Terese Barlebo Madsen, PhD; Phone Number: +4553377345; Email: marie.terese.barlebo.madsen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care; The control group will receive usual HF care in the Danish health system.
Experimental: HeartLogic-guided management; 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; HeartLogic alerts will be managed according to a standardized alert management guide to ensure uniform reactions to HeartLogic alerts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite endpoint of hospitalization for heart failure or all-cause death (first event)	42 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Hospitalization for any cardiovascular disease	42 months
Hospitalization for any cardio-respiratory disease	42 months
Hospitalization for atrial fibrillation	42 months
Atrial fibrillation burden	42 months
Hospitalization for cardiac arrest	42 months
Ventricular tachyarrhythmia leading to anti-tachycardia pacing and/or shock	42 months
Cardiovascular mortality	42 months
Incident heart failure (among participants without heart failure at baseline)	42 months
Days alive and out of hospital	42 months
Length of hospital stay	42 months
Use of guideline-directed medical therapy for heart failure	42 months
HeartLogic alert rate	42 months
Average HeartLogic index	42 months
Median HeartLogic alert length	42 months
% time in HeartLogic alert	42 months
Maximal observed HeartLogic index	42 months
Time from HeartLogic alert to clinical event	42 months
Individual HeartLogic sensor trends	42 months

Collaborators and Investigators

• Sponsor: Tor Biering-Sørensen
• Collaborators: Boston Scientific Corporation
• Investigators: Study Chair: 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 record dates

Study Major Dates

• Study Start (Actual): May 31, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Registry; ICD; Heart disease; Pacemaker; Pragmatic; CRT-D; HeartLogic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Failure; Heart Diseases
• Other Study ID Numbers: DANLOGIC-HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes