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

NCT07268807 | Not Yet Recruiting DMC

• 1 other identifier: 2025ZDSYLL380-P01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; CKD; Anemia

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

treated with Roxadustat

Drug: Roxadustat

No treated with HIF-PHIs

Interventions

Roxadustat DRUG

treated by Roxadustat

treated with Roxadustat

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda hospital Southeast University

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Heart Failure; Anemia

Interventions

roxadustat

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Wenbi Lu

CONTACT

+86 13605185175; 101012092@seu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician; Associate Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-09

Locations

CN (1)