POINTER-HF: design and rationale of a randomized clinical trial of a novel point-of-care ultrasound protocol to guide diuretic therapy in acute decompensated heart failure

Background/Introduction Point-of-care ultrasound (POCUS) has emerged as a promising tool to support clinical assessment in acute decompensated heart failure (ADHF). However, the role of POCUS in guiding treatment in ADHF remains uncertain. Current evidence is limited to small cohorts and clinical trials with conflicting results, and no prior study has evaluated a POCUS protocol specifically designed for ADHF management. Purpose To conduct a clinical trial (POINTER-HF) using a specifically designed POCUS strategy for ADHF management compared to standard of care. Methods We previously developed and validated the Dynamic Ultrasound Congestion Score (DUCS), a pragmatic POCUS-based score integrating Lung Ultrasound and Venous Excess Ultrasound according to their prognostic relevance in ADHF. DUCS was validated in patients admitted to the cardiac intensive care unit with ADFH and a left ventricular ejection fraction (LVEF) <50%. The score ranges from 0 to 10 and classifies congestion as absent, mild to moderate, or severe. DUCS independently predicted in-hospital mortality and 30-day mortality and readmission, demonstrating good calibration, accuracy and performance. POINTER-HF is a randomized, single-center, single-blind clinical trial. Eligible patients will have a primary diagnosis of ADHF, LVEF<50% and mild to moderate or severe congestion on DUCS. Hemodynamically unstable patients will be excluded. Participants will be evaluated at inclusion (day 1), day 2, day 3 and day 5. Assessments include clinical data, physical examination using the EVEREST congestion score, and standardized DUCS-based POCUS. Patients will be randomized to a POCUS-guided intervention or standard-of-care group. In the intervention group, DUCS results will guide treatment recommendations on intensive and staged use of diuretics according to a predefined protocol. Initial therapy includes intravenous (iv) furosemide at twice the usual oral dose or 40mg iv three times daily in loop-diuretic-naive patients, with early combination diuretic therapy recommended for severe congestion. Subsequent adjustments are guided by serial DUCS assessments. The control group will receive institutional standard-of-care, including EVEREST information and guideline-based treatment recommendation. The primary outcome is a pairwise comparison of a hierarchical composite outcome, ranked as follows: in-hospital mortality, length of hospital stay, absence of congestion on DUCS at discharge, and ≥30% reduction in B-type natriuretic peptide between admission and day 7 or discharge. A sample size of 128 patients provides 80% statistical power at a two-sided alpha of 0.05. The trial was approved by the local ethics committee and registered on the national clinical trial platform. Conclusions POINTER-HF will provide further evidence on the role of an intensive and staged diuretic strategy based on POCUS parameters to assist in treatment decisions and improve outcomes in ADHF.