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
1 other identifier
observational
310
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2020
CompletedFirst Posted
Study publicly available on registry
November 6, 2020
CompletedStudy Start
First participant enrolled
March 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2024
CompletedNovember 19, 2024
November 1, 2024
3.4 years
November 2, 2020
November 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospitalisation for heart failure
Annual rate of unplanned hospitalisations for heart failure
During 12 months
Secondary Outcomes (9)
Cardiovascular mortality
During 12 months
Heart failure related mortality
During 12 months
Unplanned hospitalisation due to ventricular arrhythmia
During 12 months
Unplanned hospitalisations due to atrial arrhythmia
During 12 months
Hospitalisation duration related to heart failure, ventricular or atrial arrhythmia
During 12 months
- +4 more secondary outcomes
Study Arms (1)
HeartLogic cohort
Patients implanted with a defibrillator enabling HeartLogic
Interventions
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.
Eligibility Criteria
Heart failure patients equipped with an ICD
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
University hospital of Brest
Brest, 29200, France
University hospital of Grenoble
Grenoble, France
Hospital of Lorient
Lorient, 56100, France
Clinique du Confluent
Nantes, 44000, France
University Hospital of Nantes
Nantes, France
Hopital Europeen G Pompidou
Paris, 75015, France
Hopital La Salpétrière
Paris, France
University Hospital of Poitiers
Poitiers, 86000, France
Clinique Pasteur
Toulouse, 33000, France
University Hospital of Tours
Tours, France
Related Publications (1)
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.
PMID: 41624570DERIVED
Biospecimen
1 dry tube, 1 EDTA tube and 1 lithium heparin tube
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rodrigue Garcia
University Hospital of Poitiers
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2020
First Posted
November 6, 2020
Study Start
March 10, 2021
Primary Completion
July 30, 2024
Study Completion
July 30, 2024
Last Updated
November 19, 2024
Record last verified: 2024-11