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

Sponsor

Tor Biering-Sørensen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06099158

Collaborator

Boston Scientific Corporation (Industry)

1,428

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: HeartLogic	N/A

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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1428 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

Control group will be unaware that they act as control in a randomized trial

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

May 1, 2027

Anticipated Study Completion Date :

May 1, 2027

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: HeartLogic-guided management

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.

Other: HeartLogic

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

No Intervention: Standard care

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

Outcome Measures

Primary Outcome Measures

Composite endpoint of hospitalization for heart failure or all-cause death (first event) [42 months]

Secondary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte	Hellerup	Hovedstaden	Denmark	2900

Sponsors and Collaborators

Tor Biering-Sørensen
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