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

Heart Failure Clinical Trial

— DANLOGIC-HF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06099158
• Other study ID #: DANLOGIC-HF
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: May 1, 2027

Study information

• Verified date: October 2023
• Source: Herlev and Gentofte Hospital
• Contact: Niklas Dyrby Johansen, MD
• Phone: +4520204794
• Email: niklas.dyrby.johansen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1428
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Denmark	Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte	Hellerup	Hovedstaden

Sponsors (2)

Lead Sponsor	Collaborator
Tor Biering-Sørensen	Boston Scientific Corporation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospitalizations for heart failure (recurrent events)		42 months
Other	Hierarchical composite of all-cause mortality, total number of heart failure hospitalizations, and total number of all-cause hospitalizations		42 months
Other	All-cause readmission within 30 days after hospitalization for heart failure		42 months
Other	Hospitalization for any cardiovascular disease		42 months
Other	Hospitalization for any cardio-respiratory disease		42 months
Other	Hospitalization for atrial fibrillation		42 months
Other	Atrial fibrillation burden		42 months
Other	Hospitalization for cardiac arrest		42 months
Other	Ventricular tachyarrhythmia leading to anti-tachycardia pacing and/or shock		42 months
Other	Cardiovascular mortality		42 months
Other	Incident heart failure (among participants without heart failure at baseline)		42 months
Other	Days alive and out of hospital		42 months
Other	Length of hospital stay		42 months
Other	Use of guideline-directed medical therapy for heart failure		42 months
Other	HeartLogic alert rate		42 months
Other	Average HeartLogic index		42 months
Other	Median HeartLogic alert length		42 months
Other	% time in HeartLogic alert		42 months
Other	Maximal observed HeartLogic index		42 months
Other	Time from HeartLogic alert to clinical event		42 months
Other	Individual HeartLogic sensor trends		42 months
Primary	Composite endpoint of hospitalization for heart failure or all-cause death (first event)		42 months
Secondary	Composite endpoint of hospitalization for heart failure or all-cause death (recurrent events)		42 months
Secondary	Hospitalization for heart failure (first event)		42 months
Secondary	All-cause hospitalization		42 months
Secondary	All-cause mortality		42 months