Heart FailureNCT04619888
HeartLogic France Study: Heart Failure Patients Managed with the HeartLogic Algorithm
An observational study of Heart Failure, run by Poitiers University Hospital at 10 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- HeartLogic
- How many people
- 310 participants
- Where
- 10 sitesFrance
- Study dates
- 10 Mar 2021to 30 Jul 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart failure patients equipped with an ICD
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
University hospital of Brest
Brest, 29200
University hospital of Grenoble
Grenoble
Hospital of Lorient
Lorient, 56100
Clinique du Confluent
Nantes, 44000
University Hospital of Nantes
Nantes
Hopital Europeen G Pompidou
Paris, 75015
Hopital La Salpétrière
Paris
University Hospital of Poitiers
Poitiers, 86000
Clinique Pasteur
Toulouse, 33000
University Hospital of Tours
Tours
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- HeartLogic
- Keywords
- Implantable cardioverter defibrillator, quality of life
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartLogicDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| HeartLogic cohort | Patients implanted with a defibrillator enabling HeartLogic Receives: Diagnostic Test: HeartLogic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalisation for heart failure
Annual rate of unplanned hospitalisations for heart failure
Measured: During 12 months
Secondary outcomes (9)
Cardiovascular mortality
Annual cardiovascular mortality rate
Measured: During 12 months
Heart failure related mortality
Annual death rate from heart failure
Measured: During 12 months
Unplanned hospitalisation due to ventricular arrhythmia
Annual rate of unplanned hospitalisation due to ventricular arrhythmia
Measured: During 12 months
Unplanned hospitalisations due to atrial arrhythmia
Annual rate of unplanned hospitalisations due to atrial arrhythmia
Measured: During 12 months
Hospitalisation duration related to heart failure, ventricular or atrial arrhythmia
Annual rate of hospitalisation days related to heart failure, ventricular or atrial arrhythmia
Measured: During 12 months
Patient quality of life using the Kansas City Cardiomyopathy Questionnaire
Scale title : KCCQ; Score between 0 and 100; higher scores reflect better health status
Measured: At baseline and 1 year
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
Measured: During 12 months
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
Measured: During 12 months
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.
Measured: During 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start10 Mar 2021
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 310 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodrigue Garcia, Study director, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619888
- Sponsor's protocol ID
- HeartLogic France Study
- Status last verified
- Nov 2024
- First submitted
- 2 Nov 2020
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41624570
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Heart Failure Patients with an Implantable Cardiac Defibrillator Enabled with the HeartLogic Algorithm - HeartLogic France Study
- ClinicalTrials.gov ID
- NCT04619888
- Acronym / sponsor ID
- HeartLogic France Study
- Conditions
- Heart Failure
- Keywords
- Implantable cardioverter defibrillator, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HeartLogic cohort | – | Diagnostic Test: HeartLogicPatients implanted with a defibrillator enabling HeartLogic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients equipped with an ICD
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartLogicIn 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. | Diagnostic test | HeartLogic cohort |
Primary outcome
Hospitalisation for heart failure
Time frame: During 12 months
Annual rate of unplanned hospitalisations for heart failure
9 secondary outcomes
Cardiovascular mortality
Time frame: During 12 months
Heart failure related mortality
Time frame: During 12 months
Unplanned hospitalisation due to ventricular arrhythmia
Time frame: During 12 months
Unplanned hospitalisations due to atrial arrhythmia
Time frame: During 12 months
Hospitalisation duration related to heart failure, ventricular or atrial arrhythmia
Time frame: During 12 months
Patient quality of life using the Kansas City Cardiomyopathy Questionnaire
Time frame: At baseline and 1 year
Evolution of the average HeartLogic index each week over a 12-month period
Time frame: During 12 months
Effect of iSGLT2 on HeartLogic index, atrial arrhythmias and ventricular arrhythmias
Time frame: During 12 months
Safety of preemptive congestion treatment based on HeartLogic index
Time frame: During 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Derived from this study: PubMed 41624570Garcia 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigue Garcia study director
Poitiers University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Poitiers University Hospital at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalisation for heart failure (time frame: During 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04619888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.