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NCT Number: NCT07268807

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

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.

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Key information

Conditions

Heart Failure Anemia CKD Cardiovascular Diseases Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Roxadustat

Drug

treated by Roxadustat

Primary outcomes

  1. Mace

    Time frame: 1 year

    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.

  2. BNP

    Time frame: 1 year

    B-type natriuretic peptide

  3. NYHA functional classification

    Time frame: 1 year

    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.

  4. left ventricular ejection fraction (LVEF)

    Time frame: 1 year

  5. left ventricular end-diastolic dimension (LVEDD)

    Time frame: 1 year

  6. interventricular septal thickness (IVS)

    Time frame: 1 year

  7. left ventricular posterior wall thickness (LVPW)

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Wenbi Lu

CONTACT

[email protected]

+86 13605185175

Sponsors and collaborators

Lead sponsor

Zhongda Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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