A randomized controlled trial of lung ultrasound guided therapy in heart failure (CLUSTER-HF study)

Abstract Background Lung ultrasound (LUS) has emerged as a new tool for the evaluation of congestion in HF; incorporation of LUS during follow-up may detect congestion earlier and prompt interventions to prevent hospitalizations. The aim of this study was to test the hypothesis that the incorporation of LUS during follow-up of patients with HF may reduce the rate of adverse events compared with usual care. Methods In this single blinded, randomized controlled trial, patients were randomized into a LUS-guided arm or control arm. Patients were followed in 4 pre-specified visits during a 6-month period. LUS was performed in every patient visit in both groups; however, LUS results were available for the treating physician only in the LUS group. The primary outcome was the composite of urgent HF visits, rehospitalization for worsening HF and death from any cause. Results 126 patients were randomized to either LUS (n = 63) or control (n = 63) (age 62.5 ± 10 years, median LVEF 31%). The primary endpoint occurred in 30 (47.6%) patients in the control group and 20 (31.7%) patients from the LUS group (P = .041). LUS guided treatment was associated with a 45% risk reduction in the primary endpoint (HR 0.55, 95% CI 0.31–0.98, P = .044), mainly driven by a reduction in urgent HF visits (HR 0.28, 95% CI 0.13–0.62, P = .001). No significant differences in rehospitalizations for HF or death were found. Conclusions: Incorporation of LUS into clinical follow-up of patients with HF significantly reduced the risk of urgent visits for worsening HF.