Effect of Roxadustat on Heart Failure Patients With Anaemia and Moderate-to-Severe Chronic Kidney Disease

Southeast University

Status

Not yet enrolling

Conditions

Anemia

CKD

Heart Failure

Treatments

Drug: Roxadustat

Study type

Observational

Funder types

Other

Identifiers

NCT07268807

2025ZDSYLL380-P01

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion 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

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.