Design and Rationale of the REmote Monitoring to Identify worsening Heart Failure: The REMOTI-HF Randomized Clinical Trial.

UNLABELLED: Acute decompensated heart failure (HF) is a leading cause of hospital admissions, often associated with poor outcomes. The Triage-HF (Medtronic®) and HeartLogic (Boston Scientific®) algorithms, when integrated into implantable devices, have demonstrated the ability to predict these events with high accuracy. REMOTI-HF aims to evaluate whether responding to algorithm-generated alerts through structured remote clinical assessment can reduce HF-related events and improve outcomes. The REMOTI-HF Clinical Trial is a single-centre, randomized controlled trial designed to evaluate the effectiveness of clinical evaluation and therapeutic optimization guided by the Triage-HF and HeartLogic algorithms to reduce HF-related events in patients with advanced HF. Approximately 500 patients are expected to be enrolled. Inclusion criteria include having an implantable device compatible with these algorithms and a left ventricular ejection fraction ≤35% at the time of device implantation. Patients will be excluded if they are listed for heart transplant, have ventricular mechanical support, are younger than 18 or older than 85 years, have severe cognitive impairment, are pregnant or have a life expectancy of less than one year. The primary endpoint is a composite of major HF events-including all-cause mortality, hospital admissions for HF, urgent HF hospital visits, ventricular arrhythmias and atrial arrhythmias requiring medical evaluation. The trial is registered at ClinicalTrials.gov (NCT06422832). REMOTI-HF will provide insights into the effectiveness of clinical assessment guided by HeartLogic and Triage-HF algorithm alerts in reducing HF-related events. These findings may pave the way for more sophisticated remote monitoring strategies that build on existing device algorithms. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06422832.