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.
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.
Study Type
OBSERVATIONAL
Enrollment
310
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.
University hospital of Brest
Brest, France
University hospital of Grenoble
Grenoble, France
Hospital of Lorient
Lorient, France
Clinique du Confluent
Nantes, France
University Hospital of Nantes
Nantes, France
Hopital Europeen G Pompidou
Paris, France
Hopital La Salpétrière
Paris, France
University Hospital of Poitiers
Poitiers, France
Clinique Pasteur
Toulouse, France
University Hospital of Tours
Tours, France
Hospitalisation for heart failure
Annual rate of unplanned hospitalisations for heart failure
Time frame: During 12 months
Cardiovascular mortality
Annual cardiovascular mortality rate
Time frame: During 12 months
Heart failure related mortality
Annual death rate from heart failure
Time frame: During 12 months
Unplanned hospitalisation due to ventricular arrhythmia
Annual rate of unplanned hospitalisation due to ventricular arrhythmia
Time frame: During 12 months
Unplanned hospitalisations due to atrial arrhythmia
Annual rate of unplanned hospitalisations due to atrial arrhythmia
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: During 12 months
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