HeartLogic France Study: Heart Failure Patients Managed With the HeartLogic Algorithm

Heart Failure Clinical Trial

Official title:

Follow-up of Heart Failure Patients With an Implantable Cardiac Defibrillator Enabled With the HeartLogic Algorithm - HeartLogic France Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04619888
• Other study ID #: HeartLogic France Study
• Status: Recruiting
• Start date: March 10, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: July 2023
• Source: Poitiers University Hospital
• Contact: Rodrigue Garcia
• Phone: +33549444444
• Email: celine.deletage-metreau[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• HeartLogic
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.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalisation for heart failure	Annual rate of unplanned hospitalisations for heart failure	During 12 months
Secondary	Cardiovascular mortality	Annual cardiovascular mortality rate	During 12 months
Secondary	Heart failure related mortality	Annual death rate from heart failure	During 12 months
Secondary	Unplanned hospitalisation due to ventricular arrhythmia	Annual rate of unplanned hospitalisation due to ventricular arrhythmia	During 12 months
Secondary	Unplanned hospitalisations due to atrial arrhythmia	Annual rate of unplanned hospitalisations due to atrial arrhythmia	During 12 months
Secondary	Hospitalisation duration related to heart failure, ventricular or atrial arrhythmia	Annual rate of hospitalisation days related to heart failure, ventricular or atrial arrhythmia	During 12 months
Secondary	Patient quality of life using the Kansas City Cardiomyopathy Questionnaire	Scale title : KCCQ; Score between 0 and 100; higher scores reflect better health status	At baseline and 1 year
Secondary	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	During 12 months
Secondary	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	During 12 months
Secondary	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.	During 12 months