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

ConditionsHeart FailureCKDAnemia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorZhongda Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Roxadustat

    Drug

    treated by Roxadustat

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: treated with Roxadustat1 intervention
Group B: No treated with HIF-PHIs0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year
2

BNP

B-type natriuretic peptide

Time frame
1 year
3

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.

Time frame
1 year
4

left ventricular ejection fraction (LVEF)

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhongda Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: