Impact of B‐lines‐guided intensive heart failure management on outcome of discharged heart failure patients with residual B‐lines

AIMS: Pulmonary congestion (PC) expressed by residual lung ultrasound B‐lines (LUS‐BL) could exist in some discharged heart failure (HF) patients, which is a known determinant of poor outcomes. Detection efficacy for PC is suboptimal with widely used imaging modalities, like X‐ray or echocardiography, while lung ultrasound (LUS) can sufficiently detect PC by visualizing LUS‐BL. In this trial, we sought to evaluate the impact LUS‐BL‐guided intensive HF management post‐discharge on outcome of HF patients discharged with residual LUS‐BL up to 1 year after discharge. IMP‐OUTCOME is a prospective, single‐centre, single‐blinded, randomized cohort study, which is designed to investigate if LUS‐BL‐guided intensive HF management post‐discharge in patients with residual LUS‐BL could improve the clinical outcome up to 1 year after discharge or not. METHODS AND RESULTS: After receiving the standardized treatment of HF according to current guidelines, 318 patients with ≥3 LUS‐BL assessed by LUS within 48 h before discharge will be randomly divided into the conventional HF management group and the LUS‐BL‐guided intensive HF management group at 1:1 ratio. Patient‐related basic clinical data including sex, age, blood chemistry, imaging examination, and drug utilization will be obtained and analysed. LUS‐BL will be assessed at 2 month interval post‐discharge in both groups, but LUS‐BL results will be enveloped in the conventional HF management group, and diuretics will be adjusted based on symptom and physical examination results with or without knowing the LUS‐BL results. Echocardiography examination will be performed for all patients at 12 month post‐discharge. The primary endpoint is consisted of the composite of readmission for worsening HF and all‐cause death during follow up as indicated. The secondary endpoints consisted of the change in the New York Heart Association classification, Duke Activity Status Index, N terminal pro brain natriuretic peptide value, malignant arrhythmia event and 6 min walk distance at each designed follow up, echocardiography‐derived left ventricular ejection fraction, and number of LUS‐BL at 12 month post‐discharge. Safety profile will be recorded and managed accordingly for all patients. CONCLUSIONS: This trial will explore the impact of LUS‐BL‐guided intensive HF management on the outcome of discharged HF patients with residual LUS‐BL up to 1 year after discharge in the era of sodium‐glucose cotransporter‐2 inhibitors and angiotensin receptor blocker‐neprilysin inhibitor. Trial Registration: ClinicalTrials.gov: NCT05035459