Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alert-guided remote follow-up | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-month follow-up |
| Cumulative incidence of unscheduled hospitalization for heart failure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Céline Deletage | Contact | +33549443854 | celine.deletage@chu-poitiers.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital of Amiens | Not yet recruiting | Amiens | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38234123 | Background | 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. | |
| 41624570 |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Traditional follow up | Other | Patients will be monitored every 6 months as recommended by the guidelines |
|
The cumulative incidence of unscheduled hospitalization for heart failure as defined by the Standardized Definitions for Evaluation of Heart Failure Therapies. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12-month follow-up |
| Total number of outpatient clinic consultations | 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:
| 12-month follow-up |
| University hospital of Brest | Not yet recruiting | Brest | France |
|
| University hospital of Caen | Not yet recruiting | Caen | France |
|
| University hospital of Grenoble | Not yet recruiting | Grenoble | France |
|
| University hospital of Lille | Not yet recruiting | Lille | France |
|
| La Timone University hospital | Not yet recruiting | Marseille | France |
|
| Hopital du Confluent | Not yet recruiting | Nantes | France |
|
| University hospital of Nantes | Not yet recruiting | Nantes | France |
|
| Georges Pompidou European hospital | Not yet recruiting | Paris | France |
|
| La Pitié Salpétrière | Not yet recruiting | Paris | France |
|
| University hospital of Poitiers | Recruiting | Poitiers | 86021 | France |
|
| University hospital of Rouen | Not yet recruiting | Rouen | France |
|
| Pasteur clinic | Not yet recruiting | Toulouse | France |
|
| University hospital of Toulouse | Not yet recruiting | Toulouse | France |
|
| University hospital of Tours | Not yet recruiting | Tours | France |
|
| Background |
| 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. |