Clinical trial NCT06099158: Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
Official title: Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Pragmatic
Heart disease
ICD
CRT-D
Pacemaker
Registry
HeartLogic
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2023-10-25
Enrollment: 1428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite endpoint of hospitalization for heart failure or all-cause death (first event)
timeFrame: 42 months
Secondary outcomes:
measure: Composite endpoint of hospitalization for heart failure or all-cause death (recurrent events)
timeFrame: 42 months
measure: Hospitalization for heart failure (first event)
timeFrame: 42 months
measure: All-cause hospitalization
timeFrame: 42 months
measure: All-cause mortality
timeFrame: 42 months
Other outcomes:
measure: Hospitalizations for heart failure (recurrent events)
timeFrame: 42 months
measure: Hierarchical composite of all-cause mortality, total number of heart failure hospitalizations, and total number of all-cause hospitalizations
timeFrame: 42 months
measure: All-cause readmission within 30 days after hospitalization for heart failure
timeFrame: 42 months
measure: Hospitalization for any cardiovascular disease
timeFrame: 42 months
measure: Hospitalization for any cardio-respiratory disease
timeFrame: 42 months
measure: Hospitalization for atrial fibrillation
timeFrame: 42 months
measure: Atrial fibrillation burden
timeFrame: 42 months
measure: Hospitalization for cardiac arrest
timeFrame: 42 months
measure: Ventricular tachyarrhythmia leading to anti-tachycardia pacing and/or shock
timeFrame: 42 months
measure: Cardiovascular mortality
timeFrame: 42 months
measure: Incident heart failure (among participants without heart failure at baseline)
timeFrame: 42 months
measure: Days alive and out of hospital
timeFrame: 42 months
measure: Length of hospital stay
timeFrame: 42 months
measure: Use of guideline-directed medical therapy for heart failure
timeFrame: 42 months
measure: HeartLogic alert rate
timeFrame: 42 months
measure: Average HeartLogic index
timeFrame: 42 months
measure: Median HeartLogic alert length
timeFrame: 42 months
measure: % time in HeartLogic alert
timeFrame: 42 months
measure: Maximal observed HeartLogic index
timeFrame: 42 months
measure: Time from HeartLogic alert to clinical event
timeFrame: 42 months
measure: Individual HeartLogic sensor trends
timeFrame: 42 months
Locations:
city: Hellerup
country: Denmark
facility: Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
state: Hovedstaden
Study officials:
affiliation: Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
name: Tor Biering-Sørensen, MD, MSc, MPH, PhD
role: STUDY_CHAIR
References: