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

NCT ID: NCT06099158

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1428 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-31

Study Completion Date

2027-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will be blinded to treatment allocation. Active-arm participants will be unblinded at the time of first HeartLogic alert.

Study Groups

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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.

Group Type EXPERIMENTAL

HeartLogic

Intervention Type OTHER

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

Standard care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HeartLogic

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

Intervention Type OTHER

Eligibility Criteria

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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"
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Tor Biering-Sørensen

OTHER

Sponsor Role lead

Responsible Party

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Tor Biering-Sørensen

Professor, MD, MSc, MPH, PhD, MP

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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

Role: STUDY_CHAIR

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

Locations

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

Hellerup, Capital Region, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Niklas Dyrby Johansen, MD

Role: CONTACT

+4520204794

Marie Terese Barlebo Madsen, PhD

Role: CONTACT

+4553377345

Facility Contacts

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Niklas Dyrby Johansen, MD

Role: primary

+4520204794

Marie Terese Barlebo Madsen, PhD

Role: backup

+4553377345

Other Identifiers

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DANLOGIC-HF

Identifier Type: -

Identifier Source: org_study_id

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