Remote Dielectric Sensing (ReDS) for a Safe Discharge in Patients with Acutely Decompensated Heart Failure: Rationale and Design of the ReDS-SAFE HF Study

Abstract

Fluid overload, especially pulmonary congestion, is one of the main contributors into heart failure (HF) readmission risk and it is a clinical challenge for clinicians. The Remote dielectric sensing (ReDS) system is a novel electromagnetic energy-based technology that can accurately quantify changes in lung fluid concentration noninvasively. Previous non-randomized studies suggest that ReDS-guided management has the potential to reduce readmissions in HF patients recently discharged from the hospital. The aim of this study is to test whether a ReDS-guided strategy during HF admission is superior to the standard of care during a 1-month follow up. The ReDS-SAFE trial is an investigator-initiated, single center, single blind, 2-arm randomized clinical trial, in which 250 inpatients with acutely decompensate HF will be randomized to a) standard of care strategy, with a discharge scheme based on current clinical practice, or b) ReDS-guided strategy, with a discharge scheme based on specific target value given by the device. All patients will provide signed informed consent and the protocol will be approved by Institutional Review Board of the hospital. This study will be registered in ClinicalTrials.gov. Time to the primary endpoint will be evaluated with the use of Kaplan-Meier estimates and Cox proportional hazards models. The primary outcome will be a composite of unplanned visit for HF that lead to the use of intravenous diuretics, hospitalization for worsening HF, or death from any cause at 30 days after discharge.