HeartLogic France Study: Heart Failure Patients Managed with the HeartLogic Algorithm
- Conditions
- Heart Failure
- Interventions
- Diagnostic Test: HeartLogic
- Registration Number
- NCT04619888
- Lead Sponsor
- Poitiers University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 310
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HeartLogic cohort HeartLogic Patients implanted with a defibrillator enabling HeartLogic
- Primary Outcome Measures
Name Time Method Hospitalisation for heart failure During 12 months Annual rate of unplanned hospitalisations for heart failure
- Secondary Outcome Measures
Name Time Method Cardiovascular mortality During 12 months Annual cardiovascular mortality rate
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
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
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
Trial Locations
- Locations (10)
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