HeartLogic™ in Patients With Heart Failure.
HERO
HeartLogic™ Evaluation for Remote Monitoring vs. Office-based Follow-up in Patients With Heart Failure.
1 other identifier
interventional
578
1 country
15
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Apr 2026
Typical duration for not_applicable heart-failure
15 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
March 22, 2026
CompletedStudy Start
First participant enrolled
April 15, 2026
CompletedFirst Posted
Study publicly available on registry
April 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 15, 2029
April 22, 2026
April 1, 2026
2.5 years
March 22, 2026
April 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Win ratio
12-month follow-up
Cumulative incidence of unscheduled hospitalization for heart failure
12-month follow-up
Cumulative incidence of heart failure-related death
12-month follow-up
Cumulative incidence of cardiovascular death
12-month follow-up
Number of all-cause death
12-month follow-up
- +6 more secondary outcomes
Study Arms (2)
Remote HF management guided with the HeartLogic™ algorithm.
EXPERIMENTALAfter 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 COMPARATORThe 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.
Interventions
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.
Patients will be monitored every 6 months as recommended by the guidelines
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
University hospital of Amiens
Amiens, France
University hospital of Brest
Brest, France
University hospital of Caen
Caen, France
University hospital of Grenoble
Grenoble, France
University hospital of Lille
Lille, France
La Timone University hospital
Marseille, France
Hopital du Confluent
Nantes, France
University hospital of Nantes
Nantes, France
Georges Pompidou European hospital
Paris, France
La Pitié Salpétrière
Paris, France
University hospital of Poitiers
Poitiers, 86021, France
University hospital of Rouen
Rouen, France
Pasteur clinic
Toulouse, France
University hospital of Toulouse
Toulouse, France
University hospital of Tours
Tours, France
Related Publications (2)
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.
PMID: 38234123BACKGROUNDGarcia 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: 41624570BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2026
First Posted
April 22, 2026
Study Start
April 15, 2026
Primary Completion (Estimated)
October 15, 2028
Study Completion (Estimated)
May 15, 2029
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.