HeartLogic™ in Patients With Heart Failure.
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoitiers University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Alert-guided remote follow-up
Other interventionParticipants 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.
Traditional follow up
Other interventionPatients will be monitored every 6 months as recommended by the guidelines
Treatment groups
578 Participants
are divided into 2 treatment groupsGroup A: Remote HF management guided with the HeartLogic™ algorithm.Experimental treatment 1 intervention
Group B: Conventional face-to-face HF management (no monitoring of HeartLogic alerts)Active comparator 1 intervention
Trial outcomes
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).
Time frame
12-month follow-upSecondary outcomes
1
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-up2
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-up3
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-up4
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-upSponsors and contacts
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Source ClinicalTrials.gov