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

Tor Biering-Sørensen

Status: Enrolling

Conditions: Heart Failure

Treatments: Other: HeartLogic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06099158

DANLOGIC-HF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,428 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,428 participants in 2 patient groups

HeartLogic-guided management

Experimental group

Description:

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.

Treatment:

Other: HeartLogic

Standard care

No Intervention group

Description:

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