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

Version:1.0.0 
 Study Protocol 
05/08/2025 
Effect of Roxadustat on Heart Failure Patients with 
Anaemia and Moderate-to-Severe Chronic Kidney Disease 
 
 
 
 
 
 
Protocol Number: 2025ZDSYLL380-P01 
NCT Number: Not Yet Assigned 
Principal Investigator: Wenbin Lu 
Version Number: 1.0.0 
05/08/2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Version:1.0.0 
 Study Protocol 
05/08/2025 
Objective 
Previous clinical observations of potential benefit from Roxadustat in this complex 
patient population prompted this investigation Therefore, the investigators designed 
this retrospective, observational study to thoroughly investigate the effects of 
Roxadustat on heart failure treatment and ventricular remodelling in this specific patient 
population, aiming to provide new insights for patients’ management. 
 
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:  
- 
aged 18-85 years, regardless of gender;  
- 
fulfilled the diagnostic criteria for heart failure and chronic kidney disease;  
- 
haemoglobin level <130 g/L for men or <120 g/L for women at baseline; 
- 
had regularly received Roxadustat for over one year;  
- 
possessed complete clinical data, including information from pre-specified time 
points. 
Exclusion Criteria: Patients were excluded for any of the following:  
- 
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;  
- 
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;  
- 
bilateral nephrectomy, kidney transplantation within ≤6 months, or congenital 
kidney diseases (e.g., polycystic kidney disease);  
- 
hypertrophic obstructive cardiomyopathy or congenital heart disease with right-to-
left shunt;  
- 
comorbid malignancy with an investigator-assessed life expectancy of less than 12 
months; 
- 
pregnancy or lactation;  
- 
known allergy to the study drug (active ingredient or excipients);  
- 
participation in a drug clinical trial within one year. 
This study was approved by the Ethics Committee of Zhongda Hospital Affiliated to 
Southeast University (Ethics approval number: 2025ZDSYLL380-P01). 
 
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 

Version:1.0.0 
 Study Protocol 
05/08/2025 
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.