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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
578
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
University hospital of Amiens
Amiens, France
NOT_YET_RECRUITINGUniversity hospital of Brest
Brest, France
NOT_YET_RECRUITINGUniversity hospital of Caen
Caen, France
NOT_YET_RECRUITINGUniversity hospital of Grenoble
Grenoble, France
NOT_YET_RECRUITINGUniversity hospital of Lille
Lille, France
NOT_YET_RECRUITINGLa Timone University hospital
Marseille, France
NOT_YET_RECRUITINGHopital du Confluent
Nantes, France
NOT_YET_RECRUITINGUniversity hospital of Nantes
Nantes, France
NOT_YET_RECRUITINGGeorges Pompidou European hospital
Paris, France
NOT_YET_RECRUITINGLa Pitié Salpétrière
Paris, France
NOT_YET_RECRUITING...and 5 more locations
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).
Time frame: 12-month follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
The percentage of patients with "diuretic intolerance" criterion comprising at least one of the following items: 1. 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. 2. Hypokalemia defined as a potassium level \< 3 mmol/L. 3. Hypotension defined as a systolic blood pressure \< 85 mm Hg.
Time frame: 12-month follow-up
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