Effect of Roxadustat on Heart Failure Patients With Anaemia and Moderate-to-Severe Chronic Kidney Disease: A Single-Centre Retrospective Study
Conditions: Heart Failure, CKD, Anemia
Sponsor: Zhongda Hospital

Effect of Roxadustat on Heart Failure Patients with Anaemia and Moderate-to-Severe Chronic 
Kidney Disease: A Single-Centre Retrospective Study 
 
Design 
This single-centre, retrospective, observational study was designed to evaluate the role of 
Roxadustat in improving or delaying the progression of heart failure and ventricular 
remodelling in heart failure patients with renal insufficiency and anaemia. 
Inclusion Criteria: Eligible patients met the following criteria: 1) aged 18-85 years, regardless 
of gender; 2) fulfilled the diagnostic criteria for heart failure and chronic kidney disease; 3) 
haemoglobin level <130 g/L for men or <120 g/L for women at baseline; 4) had regularly 
received Roxadustat for over one year; 5) possessed complete clinical data, including 
information from pre-specified time points. 
Exclusion Criteria: Patients were excluded for any of the following: 1) comorbid 
myelodysplastic syndromes, multiple myeloma, hereditary hematologic diseases (e.g., 
thalassemia, sickle cell anaemia, pure red cell aplasia), hemosiderosis, hemochromatosis, or 
other disorders confirmed to cause anaemia due to erythrocyte destruction and/or abnormal 
hematopoietic function; 2) haemoglobin level ≤45 g/L on two or more blood tests, a history 
of major bleeding within one year, or a history of anaemia corrected by blood transfusion; 3) 
bilateral nephrectomy, kidney transplantation within ≤6 months, or congenital kidney 
diseases (e.g., polycystic kidney disease); 4) hypertrophic obstructive cardiomyopathy or 
congenital heart disease with right-to-left shunt; 5) comorbid malignancy with an 
investigator-assessed life expectancy of less than 12 months; 6) pregnancy or lactation; 7) 
known allergy to the study drug (active ingredient or excipients); 8) participation in a drug 
clinical trial within one year. 
This study was approved by the Ethics Committee of Zhongda Hospital Affiliated to Southeast 
University. 
 
Study population 
This study retrospectively reviewed the baseline characteristics, changes in relevant 
parameters, and clinical events during one year of regular Roxadustat treatment in eligible 
patients. 
Using the electronic medical record system and the Jiangsu Provincial Medical Platform, we 
initially identified all inpatients at Zhongda Hospital Affiliated with Southeast University 
between January 2022 and December 2023 who were diagnosed with ("chronic renal 
insufficiency" OR "chronic kidney disease") AND "anaemia" AND "heart failure." Subsequent 
screening excluded duplicate entries and patients with incomplete clinical data. Following a 
review and joint confirmation by two independent investigators to ensure that all inclusion 
criteria were met and no exclusion criteria applied, and that all patients had received optimal 
medical therapy for heart failure. 
 
Outcome variables 
The primary outcome variables in this study included B-type natriuretic peptide (BNP) levels, 
NYHA functional classification, and echocardiographic measurements of left ventricular 
structure and function—specifically, left ventricular ejection fraction (LVEF), left ventricular 

end-diastolic dimension (LVEDD), interventricular septal thickness (IVS), and left ventricular 
posterior wall thickness (LVPW). Major Adverse Cardiovascular Events (MACE) and a 
composite endpoint were also evaluated. 
MACE was defined as the occurrence of any of the following: all-cause mortality, 
hospitalization for unstable 
angina 
or 
coronary 
revascularization, 
heart 
failure 
rehospitalization, or ischemic stroke. 
 
Statistical analysis 
Continuous variables are presented as mean ±  standard deviation or median with 
interquartile range, as appropriate based on their distribution. Comparisons of continuous 
variables between groups were performed using the t-test, analysis of variance (ANOVA), or 
the Mann-Whitney U test. Categorical variables are expressed as percentages and were 
compared using the Chi-square test or the Mann-Whitney U test. 
For the analysis of follow-up data within the same group, the paired t-test or the Wilcoxon 
signed-rank test was applied. To analyse outcomes based on the occurrence of Major 
Adverse Cardiovascular Events (MACE), patients were dichotomized into two groups (MACE 
vs. no MACE). Univariable analyses were then conducted to assess differences in baseline 
characteristics and treatment profiles between these groups. 
All statistical analyses were performed at Zhongda Hospital Affiliated with Southeast 
University. The SPSS statistical software (version 26.0.0, SPSS Inc., an IBM Company), R 
statistical software (version 4.5.1, R Core Team), and GraphPad Prism (version 10.0.0, 
GraphPad Software Inc.) were used for data analysis and graph generation. A two-sided P-
value of less than 0.05 was considered statistically significant.