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

Effect of Roxadustat on Heart Failure Patients With Anaemia and Moderate-to-Severe Chronic Kidney Disease: A Single-Centre Retrospective Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Anemia; CKD
• Intervention / Treatment: Drug: Roxadustat

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Wenbi Lu; Phone Number: +86 13605185175; Email: 101012092@seu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Zhongda Hospital Southeast University
      • Contact: Wenbi Lu; Phone Number: +86 13605185175; Email: 101012092@seu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Heart Failure Patients with Anaemia and Moderate-to-Severe Chronic Kidney Disease

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
treated with Roxadustat	Drug: Roxadustat; treated by Roxadustat
No treated with HIF-PHIs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mace	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.	1 year
BNP	B-type natriuretic peptide	1 year
NYHA functional classification	I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.	1 year
left ventricular ejection fraction (LVEF)		1 year
left ventricular end-diastolic dimension (LVEDD)		1 year
interventricular septal thickness (IVS)		1 year
left ventricular posterior wall thickness (LVPW)		1 year

Collaborators and Investigators

• Sponsor: Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Heart Failure; Anemia; roxadustat
• Other Study ID Numbers: 2025ZDSYLL380-P01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: No application for disclosure has been submitted to the Clinical Ethics Committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No