The GUIDE-HF protocol: a randomized controlled trial of bioelectrical impedance analysis-guided diuretic therapy on...

Patients with acute decompensation of chronic heart failure often have residual fluid retention at hospital discharge, which is closely associated with high rates of rehospitalization and mortality during the post-discharge vulnerable phase. This "revolving door" phenomenon imposes a substantial economic burden on healthcare systems and contributes significantly to inpatient bed occupancy. Current clinical assessment methods are highly subjective and lack precise quantitative indicators. This study protocol proposes a randomized controlled trial aiming to use accurately quantifiable fluid overload measured by Bioelectrical Impedance Analysis-a non-invasive, cost-effective, and portable technology-to guide diuretic therapy and optimize volume management.

This study is a single-center, open-label, randomized controlled trial with blinded endpoint assessment, and aims to enroll 538 participants at the First Affiliated Hospital of Xinjiang Medical University. Patients will be randomly assigned in a 1:1 ratio to either the intervention group (diuretic therapy guided by fluid overload measured using the Bioelectrical Impedance Analysis) or the control group (standard empirical treatment). The study aims to investigate the association between a volume management strategy guided by precise quantitative assessment of fluid overload and patient outcomes. The primary endpoint is the composite of heart failure rehospitalization or all-cause death within 3 months after discharge.

The expected results of this study will demonstrate the clinical benefits of diuretic therapy guided by a precise volume management strategy, thereby improving treatment practices for hospitalized patients with heart failure and promoting the standardized application of this approach in heart failure management. At a broader level, this study provides a paradigm for exploring precision medicine in heart failure by integrating noninvasive monitoring technologies with conventional pharmacological therapy to improve key hard clinical endpoints. Ultimately, the study supports a shift in heart failure management toward a more individualized and goal-oriented approach, offering new insights and tools to reduce the burden of heart failure and improve long-term patient outcomes. The recruitment has started and is ongoing, and this protocol outlines the study's design, methodology, and implementation framework.

https://www.chictr.org.cn/, Chinese Clinical Trial Registry, ChiCTR2500111518.