Background and Design of the Biological and Physiological Mechanisms of Symptom Clusters in Heart Failure (BIOMES-HF) Study

Background: Symptoms, which often cluster together, are a significant problem in heart failure (HF). There is considerable heterogeneity in symptom burden, particularly in the vulnerable transition period after a hospitalization for HF, and the biological underpinnings of symptoms during transitions are unclear. The purpose of this article is to describe the background and design of a study that addresses these knowledge gaps, entitled Biological and Physiological Mechanisms of Symptom Clusters in Heart Failure (BIOMES-HF). Methods and Results: BIOMES-HF is a prospective gender- and age-balanced longitudinal study of 240 adults during the 6-month transition period after a HF hospitalization. The aims are to (1) identify clusters of change in physical symptoms, (2) quantify longitudinal associations between biomarkers and physical symptoms, and (3) quantify longitudinal associations between physical frailty and physical symptoms among adults with HF. We will measure multiple symptoms, biomarkers, and physical frailty at discharge and then at 1 week and 1, 3, and 6 months after hospitalization. We will use growth mixture modeling and longitudinal mediation modeling to examine changes in symptoms, biomarkers, and physical frailty after HF hospitalization and associations therein. Conclusions: This innovative study will advance HF symptom science by using a multibiomarker panel and the physical frailty phenotype to capture the multifaceted nature of HF. Using advanced quantitative modeling, we will characterize heterogeneity and identify potential mechanisms of symptoms in HF. As a result, this research will pinpoint amenable targets for intervention to provide better, individualized treatment to improve symptom burden in HF. Lay Summary: Adults with heart failure may have significant symptom burden. This study is designed to shed light on our understanding of the role of biological and physiological mechanisms in explaining heart failure symptoms, particularly groups of co-occurring symptoms, over time. We explore how symptoms, biomarkers, and physical frailty change after a heart failure hospitalization. The knowledge generated from this study will be used to guide the management and self-care for adults with heart failure.