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

T

Tor Biering-Sørensen

Status

Not yet 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 a designated team at the central trial site 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 alert-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 central trial site. 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

  • 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.

Trial design

1,428 participants in 2 patient groups

HeartLogic-guided management
Experimental group
Description:
HeartLogic alerts will be transmitted to the central site, 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.

Trial contacts and locations

0

Loading...

Central trial contact

Marie Terese Barlebo Madsen, PhD; Niklas Dyrby Johansen, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems