Clinical trial NCT04619888: HeartLogic France Study: Heart Failure Patients Managed with the HeartLogic Algorithm
Official title: Follow-up of Heart Failure Patients with an Implantable Cardiac Defibrillator Enabled with the HeartLogic Algorithm - HeartLogic France Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Implantable cardioverter defibrillator
quality of life
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Heart failure patients equipped with an ICD

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospitalisation for heart failure
timeFrame: During 12 months
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: During 12 months
measure: Heart failure related mortality
timeFrame: During 12 months
measure: Unplanned hospitalisation due to ventricular arrhythmia
timeFrame: During 12 months
measure: Unplanned hospitalisations due to atrial arrhythmia
timeFrame: During 12 months
measure: Hospitalisation duration related to heart failure, ventricular or atrial arrhythmia
timeFrame: During 12 months
measure: Patient quality of life using the Kansas City Cardiomyopathy Questionnaire
timeFrame: At baseline and 1 year
measure: Evolution of the average HeartLogic index each week over a 12-month period
timeFrame: During 12 months
measure: Effect of iSGLT2 on HeartLogic index, atrial arrhythmias and ventricular arrhythmias
timeFrame: During 12 months
measure: Safety of preemptive congestion treatment based on HeartLogic index
timeFrame: During 12 months
Other outcomes:
Locations:
city: Brest
country: France
facility: University hospital of Brest
city: Grenoble
country: France
facility: University hospital of Grenoble
city: Lorient
country: France
facility: Hospital of Lorient
city: Nantes
country: France
facility: Clinique du Confluent
city: Nantes
country: France
facility: University Hospital of Nantes
city: Paris
country: France
facility: Hopital Europeen G Pompidou
city: Paris
country: France
facility: Hopital La Salpétrière
city: Poitiers
country: France
facility: University Hospital of Poitiers
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: University Hospital of Tours
Study officials:
affiliation: University Hospital of Poitiers
name: Rodrigue Garcia
role: STUDY_DIRECTOR
References: