HeartLogic France Study: Heart Failure Patients Managed With the HeartLogic Algorithm

Study Overview
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Brief Summary
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Heart Failure (HF) is a chronic disease that leads to numerous rehospitalisations and affects more than one million people in France. The main objective of this prospective multicentric French study is to describe the annual rate of unplanned hospitalisations for heart failure in a cohort of patients managed by a HeartLogic algorithm. Patients will be included if they fulfill the following requirements 1/Patient implanted with a cardiac defibrillator with or without resynchronisation with the HeartLogic index (RESONATE family, Boston Scientific); 2/History of heart failure (left ventricular ejection fraction ≤40 %; or at least one episode of clinical heart failure with elevated NT pro BNP≥450 ng/L). If a HeartLogic index ≥16 is noticed, the investigator will contact the patient to assess the patient's clinical condition and possibly adjust the heart failure treatment.

Detailed Description
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Heart Failure (HF) is a chronic disease that leads to numerous rehospitalisations and affects more than one million people in France. The main objective of this prospective multicentric French study is to describe the annual rate of unplanned hospitalisations for heart failure in a cohort of patients managed by a HeartLogic algorithm. 310 patients will be included if they fulfill the following requirements 1/Patient implanted with a cardiac defibrillator with or without resynchronisation with the HeartLogic index (RESONATE family, Boston Scientific); 2/History of heart failure (left ventricular ejection fraction ≤40 %; or at least one episode of clinical heart failure with elevated NT pro BNP≥450 ng/L). The HeartLogic index will be monitored remotely on a weekly basis for 12 months and in case of HeartLogic index ≥16, the local investigator will contact the patient for assessment and adjust HF treatment as necessary. The primary endpoint is unscheduled hospitalization for HF. A blind and independent committee will adjudicate the events. Blood samples will be collected for biobanking, and quality of life will be assessed.

Official Title
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Follow-up of Heart Failure Patients With an Implantable Cardiac Defibrillator Enabled With the HeartLogic Algorithm - HeartLogic France Study

Conditions
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Heart Failure

Intervention / Treatment
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* Diagnostic Test: HeartLogic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient implanted with a cardiac defibrillator, with or without resynchronization, enabled with the HeartLogic index (RESONATE family, Boston Scientific) History of heart failure (left ventricular ejection fraction ≤40 %; or at least one episode of clinical heart failure with elevated NT pro BNP≥450 ng/L) Exclusion Criteria: Concomitant presence of a heart failure device other than cardiac resynchronisation such as a left ventricular assist device or a device for modulating cardiac contractility. Heart transplant project, or heart transplant patient Glomerular filtration rate <30 ml/mn/m2 or dialysis, Life expectancy ≤ 6 months Remote monitoring of HeartLogic is not possible. Refusal to take medication for heart failure Patient with a mechanical heart valve

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HeartLogic cohort<br>Patients implanted with a defibrillator enabling HeartLogic | Diagnostic Test: HeartLogic<br>* In case of HeartLogic index ≥16, the investigator will contact the patient to assess the patient's clinical condition and possibly adjust the heart failure treatment. The management will be standardized across centers according to the Manage-HF protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalisation for heart failure | Annual rate of unplanned hospitalisations for heart failure | During 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality | Annual cardiovascular mortality rate | During 12 months | 
| Heart failure related mortality | Annual death rate from heart failure | During 12 months | 
| Unplanned hospitalisation due to ventricular arrhythmia | Annual rate of unplanned hospitalisation due to ventricular arrhythmia | During 12 months | 
| Unplanned hospitalisations due to atrial arrhythmia | Annual rate of unplanned hospitalisations due to atrial arrhythmia | During 12 months | 
| Hospitalisation duration related to heart failure, ventricular or atrial arrhythmia | Annual rate of hospitalisation days related to heart failure, ventricular or atrial arrhythmia | During 12 months | 
| Patient quality of life using the Kansas City Cardiomyopathy Questionnaire | Scale title : KCCQ; Score between 0 and 100; higher scores reflect better health status | At baseline and 1 year | 
| Evolution of the average HeartLogic index each week over a 12-month period | Scale title HL index; The lower value is 0 and there is no upper limit; A higher value reflects a higher probability of heart failure | During 12 months | 
| Effect of iSGLT2 on HeartLogic index, atrial arrhythmias and ventricular arrhythmias | Describe HeartLogic index, atrial arrhythmias and ventricular arrhythmias before and after iSGLT2 medication initiation and between patient treated or not treated with iSGLT2 treatment | During 12 months | 
| Safety of preemptive congestion treatment based on HeartLogic index | Combined diuretic intolerance criteria comprising either an increase in creatinine ≥30%, or an increase or decrease in kaliemia≥30%, or a decrease in natremia ≥30% between the time of the HeartLogic alert and the end of diuretic treatment, or the occurrence of symptomatic hypotension secondary to the initiation or increase in diuretic treatment. | During 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implantable cardioverter defibrillator, quality of life