Protocol for a Prospective, Multicenter Cohort Study on the Treatment of Chronic Cardiorenal Syndrome with Qishen Yiqi Dropping Pills.

Abstract

Background: Chronic Cardiorenal Syndrome (CRS types 2/4) involves the mutual exacerbation of heart failure and chronic kidney disease, with over half of heart failure patients affected by renal impairment that increases mortality and rehospitalization. Despite advances in management, prospective evidence for Traditional Chinese Medicine in chronic CRS is lacking. Qishen Yiqi Dropping Pills (QSYQ) have proven safe in cardiovascular care, but their concurrent renoprotective effects remain unconfirmed. Based on preliminary cardiorenal protective findings, this study evaluates QSYQ combined with standard therapy on symptoms, function, biomarkers, and outcomes in chronic CRS.

Methods: This is a prospective, multicenter, observational cohort study. Patients will be stratified into two groups based on whether or not they receive QSYQ treatment: an "Exposure Group" (standard background pharmacotherapy plus QSYQ; n=60) and a "Non-exposure Group" (standard background pharmacotherapy alone; n=60). The study duration is 270 days, with the exposure period set to the initial 90 days. Follow-up assessments will be conducted at baseline, and on days 90, 120, 180, and 270. The primary outcome measure is the 6-Minute Walk Test (6MWT). Secondary outcome measures include the New York Heart Association (NYHA) functional classification, N-terminal pro-B-type natriuretic peptide (NT-proBNP), serum creatinine (Cr), blood urea nitrogen (BUN), estimated glomerular filtration rate (eGFR), C-reactive protein (CRP), trimethylamine N-oxide (TMAO), major adverse renal and cardiovascular events (MARCE), the Veterans Specific Activity Questionnaire (VSAQ), and the Kansas City Cardiomyopathy Questionnaire (KCCQ). Throughout the entire study period, adverse events will be recorded to facilitate safety assessments.

Discussion: This study will comprehensively assess QSYQ's clinical utility for chronic CRS, evaluating functional capacity, quality of life, biomarkers, and long-term outcomes to provide prospective evidence for integrating Traditional Chinese Medicine into chronic CRS management.