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Not yet recruiting NCT07268807

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

Observational Heart Failure CKD Anemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Roxadustat.
Who it may be relevant to
Registry conditions: Heart Failure, CKD, Anemia. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Drug Roxadustat
    treated by Roxadustat

Primary outcome measures

  • Mace [Time frame: 1 year]
  • BNP [Time frame: 1 year]
  • NYHA functional classification [Time frame: 1 year]
  • left ventricular ejection fraction (LVEF) [Time frame: 1 year]
  • left ventricular end-diastolic dimension (LVEDD) [Time frame: 1 year]
  • interventricular septal thickness (IVS) [Time frame: 1 year]
  • left ventricular posterior wall thickness (LVPW) [Time frame: 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Zhongda hospital Southeast University — Nanjing

Identifiers

NCT: NCT07268807 · 2025ZDSYLL380-P01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗