HeartLogic™ in Patients With Heart Failure. (HERO)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Alert-guided remote follow-up; Other: Traditional follow up

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 Type: Interventional
• Enrollment (Estimated): 578
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Céline Deletage; Phone Number: +33549443854; Email: celine.deletage@chu-poitiers.fr

Study Locations

• France
  • Amiens, France
    • University Hospital of Amiens
    • Contact: Alexis Hermida
  • Brest, France
    • University Hospital of Brest
    • Contact: Jacques Mansourati; Phone Number: +332 98 22 33 33
  • Caen, France
    • University hospital of Caen
    • Contact: Laure Champ-Rigot
  • Grenoble, France
    • University hospital of Grenoble
    • Contact: Pascal Defaye
  • Lille, France
    • University Hospital of Lille
    • Contact: Cédric Klein
  • Marseille, France
    • La Timone University hospital
    • Contact: Baptiste Maille
  • Nantes, France
    • University Hospital of Nantes
    • Contact: Vincent Probst; Phone Number: +332 40 08 33 33
  • Nantes, France
    • Hopital du Confluent
    • Contact: Daniel Gras; Phone Number: +332 28 25 50 00
  • Paris, France
    • Georges Pompidou European hospital
    • Contact: Eloi Marijon
  • Paris, France
    • La Pitié Salpêtrière
    • Contact: Caroline Himbert
  • Poitiers, France, 86021
    • University hospital of Poitiers
    • Contact: Rodrigue Garcia; Phone Number: +33549443727; Email: rodrigue.garcia@chu-poitiers.fr
  • Rouen, France
    • University Hospital of Rouen
    • Contact: Frédéric Anselme
  • Toulouse, France
    • University Hospital of Toulouse
    • Contact: Romain Itier
  • Toulouse, France
    • Pasteur clinic
    • Contact: Serge Boveda
  • Tours, France
    • University hospital of Tours
    • Contact: Arnaud Bisson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients aged ≥18 years old;
2. Patients implanted with a cardiac defibrillator for less than 6 months, with or without resynchronization, enabling the HeartLogic™ algorithm;
3. 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);
4. Patients with New York Heart Association Class II or III HF;
5. Patient able to comply with the protocol, including Latitude™ transmissions (including adequate connectivity), and study visits.
6. Patients with compulsory health insurance

Exclusion Criteria:

1. Patients not consenting and non-compliant with remote care directions.
2. Patients with invasive remote HF monitoring device (such as CardioMems);
3. Patients with a concomitant HF device other than cardiac resynchronization, such as a ventricular assist devices or cardiac contractility modulation devices;
4. Patients on heart transplant list, or patients with a heart transplant;
5. Patients with a glomerular filtration rate <30 ml/min/m2;
6. Participation to a concomitant study evaluating management of HF decompensation, or diuretic titration.
7. Patients enable to consent.
8. Patients receiving State Medical Aid (Aide Médicale d'Etat).
9. Pregnant or breastfeeding women.
10. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote HF management guided with the HeartLogic™ algorithm.; 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.	Other: Alert-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.; Other Names: HeartLogic-guided remote follow-up
Active Comparator: Conventional face-to-face HF management (no monitoring of HeartLogic alerts); 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.	Other: Traditional follow up; Patients will be monitored every 6 months as recommended by the guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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: 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.	12-month follow-up

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): October 15, 2028
• Study Completion (Estimated): May 15, 2029

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: April 18, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; heart failure; hospitalization; implantable cardioverter defibrillator; remote monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: HERO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No