HeartLogic France Study: Heart Failure Patients Managed w... | NCT04619888

Studies
HeartLogic France Study: Heart Failure Patients Managed with the HeartLogic Algorithm

NCT04619888

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Nov 19, 2024Actual

Enrollment

310Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

HeartLogic

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2021Actual

Primary Completion Date

Jul 30, 2024Actual

Completion Date

Jul 30, 2024Actual

First Submitted Date

Nov 2, 2020

First Submission Date that Met QC Criteria

Nov 2, 2020

First Posted Date

Nov 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2024

Last Update Posted Date

Nov 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

310Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HeartLogic cohort		Patients implanted with a defibrillator enabling HeartLogic	Diagnostic Test: HeartLogic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HeartLogic	Diagnostic Test	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospitalisation for heart failure	Annual rate of unplanned hospitalisations for heart failure	During 12 months

Secondary Outcomes

Measure	Description	Time Frame
Cardiovascular mortality	Annual cardiovascular mortality rate	During 12 months
Heart failure related mortality	Annual death rate from heart failure

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Heart failure patients equipped with an ICD

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rodrigue Garcia	Poitiers University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital of Brest		Brest		29200	France
University hospital of Grenoble

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41624570	Derived	Garcia R, Gras D, Mansourati J, Defaye P, Bisson A, Boveda S, Durocher L, Gandjbakhch E, Gras M, Gueffet JP, Himbert C, Jacon P, Khattar P, Lequeux B, Li A, Mansourati V, Minois D, Marijon E, Pierre B, Ragot S, Probst V, Degand B. Impact and safety of remote monitoring of heart failure patients managed with the HeartLogic algorithm: the HeartLogic France Cohort Study. Eur Heart J Digit Health. 2025 Nov 13;7(2):ztaf133. doi: 10.1093/ehjdh/ztaf133. eCollection 2026 Mar.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases