Early Discharge to Clinic-Based Therapy of Patients Presenting With Decompensated Heart Failure (EDICT-HF): Study Protocol for a Multi-Centre Randomised Controlled Trial

Background Acute decompensated heart failure involves a high rate of mortality and complications. Management typically involves a multi -day hospital admission. However, patients often lose part of their function with each successive admission, and are at a high risk for hospital -associated complications such as nosocomial infection. This study aims to determine the safety and efficacy of the management of patients presenting with acute decompensated heart failure to clinic -based therapy vs usual inpatient care using a reproducible management pathway. Method An investigator -initiated, prospective, non -inferiority, 1:1 randomised -controlled trial, stratified by left ventricular ejection fraction including 460 patients with a minimum follow-up of 7 days. This is a multicentre study to be performed in centres across Victoria, Australia. Participants will be patients with either heart failure with reduced ejection fraction (HFrEF) or heart failure with preserved ejection fraction (HFpEF), admitted for acute decompensation of heart failure. Intervention: Early discharge to an outpatient -based Heart Failure Rapid Access Clinical Review (RACER) in addition to frequent medical/ nursing at-home review for patients admitted with decompensated heart failure. Results The primary endpoint will be a non -inferiority assessment of re -hospitalisation at 30 days. Secondary outcomes include superiority assessment of hospitalisation at 30 days, a composite clinical endpoint of major adverse cardiac and cerebrovascular event (MACCE), hospital re -admission or mortality at 3 months, achievement of guideline -directed medical therapy, patient assessment of symptoms (visualanalogue scale quantified as area under curve and Kansas City Cardiomyopathy Questionnaire -12 [KCCQ-12]), attendance at 3 -month outpatient follow-up, number of bed stays/clinics attended, proportion of patients free from congestion, change in serum creatinine level, treatment for electrolyte disturbances, time to transition from intravenous to oral diuretics, and health economics analysis (costbenefit analysis, cost -utility analysis, incremental cost-effectiveness ratio). Conclusions The Early Discharge to Clinic -Based Therapy of Patients Presenting with Decompensated Heart Failure (EDICT-HF) trial will help determine whether earlier discharge to out -of -hospital care is non -inferior to the usual practice of inpatient care, in patients with heart failure admitted to hospital for acute decompensation, as an alternative model of care.