Heart Failure Clinical Trial
— DANLOGIC-HFOfficial title:
Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
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.
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 LATITUDEā¢ remote monitoring system as "not monitored" Exclusion Criteria: There are no specific exclusion criteria for the trial. |
Country | Name | City | State |
---|---|---|---|
Denmark | Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte | Hellerup | Hovedstaden |
Lead Sponsor | Collaborator |
---|---|
Tor Biering-Sørensen | Boston Scientific Corporation |
Denmark,
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 |
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