Heart FailureHERONCT07544771
HeartLogic™ in Patients With Heart Failure.
A study testing Alert-guided remote follow-up and Traditional follow up in people with Heart Failure, run by Poitiers University Hospital at 15 sites in France.
Trial summary
This randomized, multicenter clinical trial will evaluate whether remote management guided by the HeartLogic™ algorithm improves outcomes compared with traditional face-to-face follow-up in adult patients with heart failure recently implanted with a HeartLogic™-enabled ICD or CRT-D device. 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?
- Alert-guided remote follow-up and Traditional follow up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 578 participants
- Where
- 15 sitesFrance
- Study dates
- 29 Apr 2026to 15 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients aged ≥18 years old;
- Patients implanted with a cardiac defibrillator for less than 6 months, with or without resynchronization, enabling the HeartLogic™ algorithm;
- Patients with a history of HF (left ventricular ejection fraction ≤40%; or at least one episode of clinical HF with NT-proBNP blood concentration ≥450 ng/L);
- Patients with New York Heart Association Class II or III HF;
- Patient able to comply with the protocol, including Latitude™ transmissions (including adequate connectivity), and study visits.
- Patients with compulsory health insurance
Who cannot join
- Patients not consenting and non-compliant with remote care directions.
- Patients with invasive remote HF monitoring device (such as CardioMems);
- Patients with a concomitant HF device other than cardiac resynchronization, such as a ventricular assist devices or cardiac contractility modulation devices;
- Patients on heart transplant list, or patients with a heart transplant;
- Patients with a glomerular filtration rate <30 ml/min/m2;
- Participation to a concomitant study evaluating management of HF decompensation, or diuretic titration.
Show all 10Show fewer
- Patients enable to consent.
- Patients receiving State Medical Aid (Aide Médicale d'Etat).
- Pregnant or breastfeeding women.
- Persons benefiting from a reinforced protection, namely minors, persons deprived of liberty by a judicial or administrative decision, adults under legal protection, and finally patients in emergency situations
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
France15 sites, 15 recruiting
- Not yet recruiting
University hospital of Amiens
Amiens
Alexis Hermida
- Not yet recruiting
University hospital of Brest
Brest
Jacques Mansourati, +332 98 22 33 33
- Not yet recruiting
University hospital of Caen
Caen
Laure Champ-Rigot
- Not yet recruiting
University hospital of Grenoble
Grenoble
Pascal Defaye
- Not yet recruiting
University hospital of Lille
Lille
Cédric Klein
- Not yet recruiting
La Timone University hospital
Marseille
Baptiste Maille
- Not yet recruiting
Hopital du Confluent
Nantes
Daniel Gras, +332 28 25 50 00
- Not yet recruiting
University hospital of Nantes
Nantes
Vincent Probst, +332 40 08 33 33
- Not yet recruiting
Georges Pompidou European hospital
Paris
Eloi Marijon
- Not yet recruiting
La Pitié Salpétrière
Paris
Caroline Himbert
- Recruiting
University hospital of Poitiers
Poitiers, 86021
Rodrigue Garcia, +33549443727, rodrigue.garcia@chu-poitiers.fr
- Not yet recruiting
University hospital of Rouen
Rouen
Frédéric Anselme
- Not yet recruiting
Pasteur clinic
Toulouse
Serge Boveda
- Not yet recruiting
University hospital of Toulouse
Toulouse
Romain Itier
- Not yet recruiting
University hospital of Tours
Tours
Arnaud Bisson
About this study
Official title: HeartLogic™ Evaluation for Remote Monitoring vs. Office-based Follow-up in Patients With Heart Failure.
This randomized, multicenter clinical trial will evaluate whether remote management guided by the HeartLogic™ algorithm improves outcomes compared with traditional face-to-face follow-up in adult patients with heart failure recently implanted with a HeartLogic™-enabled ICD or CRT-D device. The primary objective is to determine whether this strategy reduces, at 12 months, the proportion of patients with death, unscheduled hospitalization for heart failure, or deterioration in quality of life. Secondary objectives include assessment of hospitalization, mortality, quality of life, safety, and cost-effectiveness.
Read the detailed description
Heart failure is associated with recurrent decompensation, frequent hospitalization, impaired quality of life, and substantial healthcare costs. HeartLogic™ is a multisensor algorithm available in compatible Boston Scientific ICD and CRT-D devices that integrates device-derived parameters, including heart sounds, thoracic impedance, respiratory rate, heart rate, and activity level, to identify early signs of worsening heart failure.
Although previous studies have shown that HeartLogic™ alerts may precede heart failure events, the benefit of a structured management strategy based on these alerts has not been established in a randomized trial. The HERO study is a prospective, multicenter, open-label, randomized, parallel-group trial designed to evaluate this strategy in routine practice.
Participants will be randomized to either HeartLogic™-guided remote management or conventional face-to-face follow-up without use of HeartLogic™ alerts. In the intervention group, alerts transmitted through the Latitude™ platform may trigger patient contact, clinical assessment, and therapeutic adjustment according to a predefined management pathway and local practice. In both groups, patient-reported outcomes and clinical events will be collected during 12 months of follow-up.
The study also includes a health economic evaluation to compare the cost-effectiveness of the 2 management strategies.
- Conditions
- Heart Failure
- Being tested
- Alert-guided remote follow-up, Traditional follow up
- Keywords
- heart failure, implantable cardioverter defibrillator, remote monitoring, hospitalization, 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.
Alert-guided remote follow-upOther
Also called HeartLogic-guided remote follow-up
Participants assigned to this intervention will receive alert-guided remote follow-up for heart failure. Device-generated alerts suggestive of worsening heart failure will be reviewed by the study team through the remote monitoring platform. When an alert occurs, patients may be contacted for symptom assessment and clinical evaluation, and treatment may be adjusted preemptively according to a predefined care pathway and local clinical practice.
Traditional follow upOther
Patients will be monitored every 6 months as recommended by the guidelines
| Study group | Role | What they receive |
|---|---|---|
| Remote HF management guided with the HeartLogic™ algorithm. | Experimental | After enrolment, patients of the intervention arm will be remotely followed up based on an alert-driven strategy by the local research coordinator. In case of index value ≥16, diuretics should be increased during 4 to 5 days, or HF guidelines directed medication therapy will be up titrated. Receives: Other: Alert-guided remote follow-up |
| Conventional face-to-face HF management (no monitoring of HeartLogic alerts) | Active comparator | The control group is treated with a usual follow-up. Current guidelines recommend follow-up at intervals no longer than 6 months. They will be monitored at baseline, 6 and 12 months after inclusion. Receives: Other: Traditional follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who are alive with no unscheduled hospitalization for heart failure and no deterioration in quality of life.
The primary outcome is the proportion of patients, at 12 months, who are alive with no unscheduled hospitalization for heart failure and no deterioration in quality of life, defined as a reduction of 5 points or more in the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Measured: 12-month follow-up
Secondary outcomes (11)
Win ratio
The win ratio constituted by the three following outcomes in this order of priority: the time-to-death, time-to- unscheduled hospitalization for HF, and a 5-point difference in the KCCQ score.
Measured: 12-month follow-up
Cumulative incidence of unscheduled hospitalization for heart failure
The cumulative incidence of unscheduled hospitalization for heart failure as defined by the Standardized Definitions for Evaluation of Heart Failure Therapies.
Measured: 12-month follow-up
Cumulative incidence of heart failure-related death
The cumulative incidence of HF-related death (i.e. Pump failure death) as defined by the Standardized Definitions for Evaluation of Heart Failure Therapies.
Measured: 12-month follow-up
Cumulative incidence of cardiovascular death
The cumulative incidence of cardiovascular death as defined by the Standardized Definitions for Evaluation of Heart Failure Therapies. Cardiovascular death is defined as a death with a defined cardiovascular cause such as acute myocardial infarction, arrhythmia or conduction system disturbance, cardiogenic shock, cardiovascular device failure, cardiovascular hemorrhage, cardiovascular infection, cardiovascular procedure-related, heart failure, peripheral arterial disease, thromboembolism, stroke, and sudden cardiac death. Deaths of unknown causes and not clearly cardiovascular or non-cardiovascular should be classified as unknown or undetermined.
Measured: 12-month follow-up
Number of all-cause death
Time from randomization to death from any cause during follow-up. Participants not experiencing death will be censored at the end of follow-up.
Measured: 12-month follow-up
Change in quality of life
The mean of the quality-of-life between baseline and 12 months of follow-up assessed with the Kansas City Cardiomyopathy Questionnaire. The minimum score is 0 and the maximum score is 100. A high score means a betterquality of life.
Measured: Change between baseline and 12 months of follow-up
The efficiency of patient care in terms of cost-utility
The efficiency will be assessed with an incremental cost-effectiveness ratio, i.e., the ratio of the difference in costs between the two therapeutic sequences divided by the difference in QALYs. It measures the cost per year of life at full health saved from choosing the therapeutic sequence that provided the greatest number of QALYs. The QALYs will be estimated by multiplying the time spent in a health state by the utility score given to that health state. The utility will be assessed by EQ-5D questionnaire at each visit from inclusion the study endpoint. The cost criteria will be the total cost of patient care at 12 months from health-care payer's and patient's perspective from inclusion to the study endpoint.
Measured: 12-month follow-up
Total number of hospitalization
Hospitalization is defined as a formal inpatient admission to a healthcare facility for diagnosis, treatment, or monitoring, as documented in the medical record.
Measured: 12-month follow-up
Total hospitalization duration
The total hospitalization duration is defined as the time interval between the date of hospital admission and the date of hospital discharge.
Measured: 12-month follow-up
Total number of outpatient clinic consultations
Measured: 12-month follow-up
Proportion of patients with a safety criteria
The percentage of patients with "diuretic intolerance" criterion comprising at least one of the following items:
- Acute renal failure defined as doubling of the serum creatinine level from baseline, or a decrease of at least 50% in the estimated GFR, or renal-replacement therapy.
- Hypokalemia defined as a potassium level < 3 mmol/L.
- Hypotension defined as a systolic blood pressure < 85 mm Hg.
Measured: 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start29 Apr 2026
- Primary completion15 Oct 2028 (estimated)
- Study completion15 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 578 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544771
- Sponsor's protocol ID
- HERO
- Acronym
- HERO
- Status last verified
- Oct 2026
- First submitted
- 22 Mar 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected in this study will not be made available. Under the French legal and regulatory framework applicable to this research, sharing of individual-level participant data is not permitted outside the authorized study framework.
Publications
Garcia R, Gras D, Mansourati J, Defaye P, Bisson A, Boveda S, Gandjbakhch E, Gras M, Gueffet JP, Himbert C, Jacon P, Khattar P, Lequeux B, Li A, Mansourati V, Minois D, Marijon E, Pierre B, Probst V, Degand B; HeartLogic France Cohort Study Investigators. Pre-emptive treatment of heart failure exacerbations in patients managed with the HeartLogic algorithm. ESC Heart Fail. 2024 Apr;11(2):1228-1235. doi: 10.1002/ehf2.14624. Epub 2024 Jan 17.
PubMed 38234123Garcia 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HeartLogic™ Evaluation for Remote Monitoring vs. Office-based Follow-up in Patients With Heart Failure.
- ClinicalTrials.gov ID
- NCT07544771
- Acronym / sponsor ID
- HERO / HERO
- Conditions
- Heart Failure
- Keywords
- heart failure, implantable cardioverter defibrillator, remote monitoring, hospitalization, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 578 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 15 Oct 2028 (estimated)
- Study completion
- 15 May 2029 (estimated)
- First posted
- 22 Apr 2026 (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.
This randomized, multicenter clinical trial will evaluate whether remote management guided by the HeartLogic™ algorithm improves outcomes compared with traditional face-to-face follow-up in adult patients with heart failure recently implanted with a HeartLogic™-enabled ICD or CRT-D device. The primary objective is to determine whether this strategy reduces, at 12 months, the proportion of patients with death, unscheduled hospitalization for heart failure, or deterioration in quality of life. Secondary objectives include assessment of hospitalization, mortality, quality of life, safety, and cost-effectiveness.
Detailed description
Heart failure is associated with recurrent decompensation, frequent hospitalization, impaired quality of life, and substantial healthcare costs. HeartLogic™ is a multisensor algorithm available in compatible Boston Scientific ICD and CRT-D devices that integrates device-derived parameters, including heart sounds, thoracic impedance, respiratory rate, heart rate, and activity level, to identify early signs of worsening heart failure.
Although previous studies have shown that HeartLogic™ alerts may precede heart failure events, the benefit of a structured management strategy based on these alerts has not been established in a randomized trial. The HERO study is a prospective, multicenter, open-label, randomized, parallel-group trial designed to evaluate this strategy in routine practice.
Participants will be randomized to either HeartLogic™-guided remote management or conventional face-to-face follow-up without use of HeartLogic™ alerts. In the intervention group, alerts transmitted through the Latitude™ platform may trigger patient contact, clinical assessment, and therapeutic adjustment according to a predefined management pathway and local practice. In both groups, patient-reported outcomes and clinical events will be collected during 12 months of follow-up.
The study also includes a health economic evaluation to compare the cost-effectiveness of the 2 management strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote HF management guided with the HeartLogic™ algorithm. | Experimental | Other: Alert-guided remote follow-upAfter enrolment, patients of the intervention arm will be remotely followed up based on an alert-driven strategy by the local research coordinator. In case of index value ≥16, diuretics should be increased during 4 to 5 days, or HF guidelines directed medication therapy will be up titrated. |
| Conventional face-to-face HF management (no monitoring of HeartLogic alerts) | Active comparator | Other: Traditional follow upThe control group is treated with a usual follow-up. Current guidelines recommend follow-up at intervals no longer than 6 months. They will be monitored at baseline, 6 and 12 months after inclusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged ≥18 years old;
- Patients implanted with a cardiac defibrillator for less than 6 months, with or without resynchronization, enabling the HeartLogic™ algorithm;
- Patients with a history of HF (left ventricular ejection fraction ≤40%; or at least one episode of clinical HF with NT-proBNP blood concentration ≥450 ng/L);
- Patients with New York Heart Association Class II or III HF;
- Patient able to comply with the protocol, including Latitude™ transmissions (including adequate connectivity), and study visits.
Key exclusion criteria (10 listed)
- Patients not consenting and non-compliant with remote care directions.
- Patients with invasive remote HF monitoring device (such as CardioMems);
- Patients with a concomitant HF device other than cardiac resynchronization, such as a ventricular assist devices or cardiac contractility modulation devices;
- Patients on heart transplant list, or patients with a heart transplant;
- Patients with a glomerular filtration rate <30 ml/min/m2;
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 |
|---|---|---|
| Alert-guided remote follow-upAlso: HeartLogic-guided remote follow-upParticipants assigned to this intervention will receive alert-guided remote follow-up for heart failure. Device-generated alerts suggestive of worsening heart failure will be reviewed by the study team through the remote monitoring platform. When an alert occurs, patients may be contacted for symptom assessment and clinical evaluation, and treatment may be adjusted preemptively according to a predefined care pathway and local clinical practice. | Other | Remote HF management guided with the HeartLogic™ algorithm. |
| Traditional follow upPatients will be monitored every 6 months as recommended by the guidelines | Other | Conventional face-to-face HF management (no monitoring of HeartLogic alerts) |
Primary outcome
Proportion of patients who are alive with no unscheduled hospitalization for heart failure and no deterioration in quality of life.
Time frame: 12-month follow-up
The primary outcome is the proportion of patients, at 12 months, who are alive with no unscheduled hospitalization for heart failure and no deterioration in quality of life, defined as a reduction of 5 points or more in the Kansas City Cardiomyopathy Questionnaire (KCCQ).
11 secondary outcomes
Win ratio
Time frame: 12-month follow-up
Cumulative incidence of unscheduled hospitalization for heart failure
Time frame: 12-month follow-up
Cumulative incidence of heart failure-related death
Time frame: 12-month follow-up
Cumulative incidence of cardiovascular death
Time frame: 12-month follow-up
Number of all-cause death
Time frame: 12-month follow-up
Change in quality of life
Time frame: Change between baseline and 12 months of follow-up
The efficiency of patient care in terms of cost-utility
Time frame: 12-month follow-up
Total number of hospitalization
Time frame: 12-month follow-up
Total hospitalization duration
Time frame: 12-month follow-up
Total number of outpatient clinic consultations
Time frame: 12-month follow-up
Proportion of patients with a safety criteria
Time frame: 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Background: PubMed 38234123Garcia R, Gras D, Mansourati J, Defaye P, Bisson A, Boveda S, Gandjbakhch E, Gras M, Gueffet JP, Himbert C, Jacon P, Khattar P, Lequeux B, Li A, Mansourati V, Minois D, Marijon E, Pierre B, Probst V, Degand B; HeartLogic France Cohort Study Investigators. Pre-emptive treatment of heart failure exacerbations in patients managed with the HeartLogic algorithm. ESC Heart Fail. 2024 Apr;11(2):1228-1235. doi: 10.1002/ehf2.14624. Epub 2024 Jan 17.
- Background: 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: No. Individual participant data collected in this study will not be made available. Under the French legal and regulatory framework applicable to this research, sharing of individual-level participant data is not permitted outside the authorized study framework.
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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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alert-guided remote follow-up and Traditional follow up in people with Heart Failure, run by Poitiers University Hospital at 15 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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Céline Deletage (+33549443854, celine.deletage@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who are alive with no unscheduled hospitalization for heart failure and no deterioration in quality of life. (time frame: 12-month follow-up). 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 NCT07544771, which also lists 2 linked publications.
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 Oct 2026.