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

Primary Purpose

Heart Failure

Status

Not yet recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

HeartLogic

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Pragmatic, Heart disease, ICD, CRT-D, Pacemaker, Registry, HeartLogic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HeartLogic-guided management

Standard care

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Composite endpoint of hospitalization for heart failure or all-cause death (recurrent events)

Hospitalization for heart failure (first event)

All-cause hospitalization

All-cause mortality

Full Information

NCT ID

NCT06099158

First Posted

October 19, 2023

Last Updated

October 19, 2023

Sponsor

Tor Biering-Sørensen

Collaborators

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT06099158

Brief Title

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

Acronym

DANLOGIC-HF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 1, 2023 (Anticipated)

Primary Completion Date

May 1, 2027 (Anticipated)

Study Completion Date

May 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Tor Biering-Sørensen

Collaborators

Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Pragmatic, Heart disease, ICD, CRT-D, Pacemaker, Registry, HeartLogic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Masking Description

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

Allocation

Randomized

Enrollment

1428 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HeartLogic-guided management

Arm Type

Experimental

Arm Description

Arm Title

Standard care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

HeartLogic

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

42 months

Secondary Outcome Measure Information:

Title

Composite endpoint of hospitalization for heart failure or all-cause death (recurrent events)

Time Frame

42 months

Title

Hospitalization for heart failure (first event)

Time Frame

42 months

Title

All-cause hospitalization

Time Frame

42 months

Title

All-cause mortality

Time Frame

42 months

Other Pre-specified Outcome Measures:

Title

Hospitalizations for heart failure (recurrent events)

Time Frame

42 months

Title

Hierarchical composite of all-cause mortality, total number of heart failure hospitalizations, and total number of all-cause hospitalizations

Time Frame

42 months

Title

All-cause readmission within 30 days after hospitalization for heart failure

Time Frame

42 months

Title

Hospitalization for any cardiovascular disease

Time Frame

42 months

Title

Hospitalization for any cardio-respiratory disease

Time Frame

42 months

Title

Hospitalization for atrial fibrillation

Time Frame

42 months

Title

Atrial fibrillation burden

Time Frame

42 months

Title

Hospitalization for cardiac arrest

Time Frame

42 months

Title

Ventricular tachyarrhythmia leading to anti-tachycardia pacing and/or shock

Time Frame

42 months

Title

Cardiovascular mortality

Time Frame

42 months

Title

Incident heart failure (among participants without heart failure at baseline)

Time Frame

42 months

Title

Days alive and out of hospital

Time Frame

42 months

Title

Length of hospital stay

Time Frame

42 months

Title

Use of guideline-directed medical therapy for heart failure

Time Frame

42 months

Title

HeartLogic alert rate

Time Frame

42 months

Title

Average HeartLogic index

Time Frame

42 months

Title

Median HeartLogic alert length

Time Frame

42 months

Title

% time in HeartLogic alert

Time Frame

42 months

Title

Maximal observed HeartLogic index

Time Frame

42 months

Title

Time from HeartLogic alert to clinical event

Time Frame

42 months

Title

Individual HeartLogic sensor trends

Time Frame

42 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Niklas Dyrby Johansen, MD

Phone

+4520204794

niklas.dyrby.johansen@regionh.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Marie Terese Barlebo Madsen, PhD

Phone

+4553377345

marie.terese.barlebo.madsen@regionh.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Hellerup

State/Province

Hovedstaden

ZIP/Postal Code

2900

Country

Denmark

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Niklas Dyrby Johansen, MD

Phone

+4520204794

niklas.dyrby.johansen@regionh.dk

First Name & Middle Initial & Last Name & Degree

Marie Terese Barlebo Madsen, PhD

Phone

+4553377345

marie.terese.barlebo.madsen@regionh.dk

First Name & Middle Initial & Last Name & Degree

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

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.

Learn more about this trial

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

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