Heart Failure
Conditions
Keywords
heart failure, implantable cardioverter defibrillator, remote monitoring, hospitalization, quality of life
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.
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.
Interventions
OTHERAlert-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.
OTHERTraditional follow up
Patients will be monitored every 6 months as recommended by the guidelines
Sponsors
Poitiers University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who are alive with no unscheduled hospitalization for heart failure and no deterioration in quality of life. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Win ratio | 12-month follow-up | 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. |
| Cumulative incidence of unscheduled hospitalization for heart failure | 12-month follow-up | The cumulative incidence of unscheduled hospitalization for heart failure as defined by the Standardized Definitions for Evaluation of Heart Failure Therapies. |
| Cumulative incidence of heart failure-related death | 12-month follow-up | The cumulative incidence of HF-related death (i.e. Pump failure death) as defined by the Standardized Definitions for Evaluation of Heart Failure Therapies. |
| Cumulative incidence of cardiovascular death | 12-month follow-up | 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. |
| Number of all-cause death | 12-month follow-up | Time from randomization to death from any cause during follow-up. Participants not experiencing death will be censored at the end of follow-up. |
| Change in quality of life | Change between baseline and 12 months of follow-up | 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. |
| The efficiency of patient care in terms of cost-utility | 12-month follow-up | 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. |
| Total number of hospitalization | 12-month follow-up | Hospitalization is defined as a formal inpatient admission to a healthcare facility for diagnosis, treatment, or monitoring, as documented in the medical record. |
| Total hospitalization duration | 12-month follow-up | The total hospitalization duration is defined as the time interval between the date of hospital admission and the date of hospital discharge. |
| Total number of outpatient clinic consultations | 12-month follow-up | — |
| Proportion of patients with a safety criteria | 12-month follow-up | 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. |
Countries
France
Contacts
CONTACTCéline Deletage
Outcome results
None listed