Heart Failure
Conditions
Keywords
Implantable cardioverter defibrillator, quality of life
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTHeartLogic
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.
Sponsors
Poitiers University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalisation for heart failure | During 12 months | Annual rate of unplanned hospitalisations for heart failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart failure related mortality | During 12 months | Annual death rate from heart failure |
| Unplanned hospitalisation due to ventricular arrhythmia | During 12 months | Annual rate of unplanned hospitalisation due to ventricular arrhythmia |
| Unplanned hospitalisations due to atrial arrhythmia | During 12 months | Annual rate of unplanned hospitalisations due to atrial arrhythmia |
| Hospitalisation duration related to heart failure, ventricular or atrial arrhythmia | During 12 months | Annual rate of hospitalisation days related to heart failure, ventricular or atrial arrhythmia |
| Cardiovascular mortality | During 12 months | Annual cardiovascular mortality rate |
| Evolution of the average HeartLogic index each week over a 12-month period | During 12 months | 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 |
| Effect of iSGLT2 on HeartLogic index, atrial arrhythmias and ventricular arrhythmias | During 12 months | Describe HeartLogic index, atrial arrhythmias and ventricular arrhythmias before and after iSGLT2 medication initiation and between patient treated or not treated with iSGLT2 treatment |
| Safety of preemptive congestion treatment based on HeartLogic index | During 12 months | 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. |
| Patient quality of life using the Kansas City Cardiomyopathy Questionnaire | At baseline and 1 year | Scale title : KCCQ; Score between 0 and 100; higher scores reflect better health status |
Countries
France
Outcome results
None listed