HeartLogic France Study: Heart Failure Patients Managed with the HeartLogic Algorithm
Follow-up of Heart Failure Patients with an Implantable Cardiac Defibrillator Enabled with the HeartLogic Algorithm - HeartLogic France Study
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Brest, France, 29200
- University Hospital of Brest
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Grenoble, France
- University Hospital of Grenoble
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Lorient, France, 56100
- Hospital of Lorient
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Nantes, France
- University Hospital of Nantes
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Nantes, France, 44000
- Clinique du Confluent
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Paris, France, 75015
- Hôpital Européen G Pompidou
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Paris, France
- Hôpital la Salpêtrière
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Poitiers, France, 86000
- University Hospital of Poitiers
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Toulouse, France, 33000
- Clinique Pasteur
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Tours, France
- University Hospital of Tours
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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HeartLogic cohort
Patients implanted with a defibrillator enabling HeartLogic
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospitalisation for heart failure
Time Frame: During 12 months
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Annual rate of unplanned hospitalisations for heart failure
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During 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient quality of life using the Kansas City Cardiomyopathy Questionnaire
Time Frame: At baseline and 1 year
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Scale title : KCCQ; Score between 0 and 100; higher scores reflect better health status
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At baseline and 1 year
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Evolution of the average HeartLogic index each week over a 12-month period
Time Frame: During 12 months
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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
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During 12 months
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Cardiovascular mortality
Time Frame: During 12 months
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Annual cardiovascular mortality rate
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During 12 months
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Heart failure related mortality
Time Frame: During 12 months
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Annual death rate from heart failure
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During 12 months
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Unplanned hospitalisation due to ventricular arrhythmia
Time Frame: During 12 months
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Annual rate of unplanned hospitalisation due to ventricular arrhythmia
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During 12 months
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Unplanned hospitalisations due to atrial arrhythmia
Time Frame: During 12 months
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Annual rate of unplanned hospitalisations due to atrial arrhythmia
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During 12 months
|
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Hospitalisation duration related to heart failure, ventricular or atrial arrhythmia
Time Frame: During 12 months
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Annual rate of hospitalisation days related to heart failure, ventricular or atrial arrhythmia
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During 12 months
|
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Effect of iSGLT2 on HeartLogic index, atrial arrhythmias and ventricular arrhythmias
Time Frame: During 12 months
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Describe HeartLogic index, atrial arrhythmias and ventricular arrhythmias before and after iSGLT2 medication initiation and between patient treated or not treated with iSGLT2 treatment
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During 12 months
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Safety of preemptive congestion treatment based on HeartLogic index
Time Frame: During 12 months
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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.
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During 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Rodrigue Garcia, University Hospital of Poitiers
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HeartLogic France Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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