Effect of Roxadustat on Heart Failure Patients With Anaemia and Moderate-to-Severe Chronic Kidney Disease: A Single-Centre Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- left ventricular posterior wall thickness (LVPW)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
treated with Roxadustat
干预措施: Roxadustat (Drug)
结局指标
主要结局
left ventricular posterior wall thickness (LVPW)
时间窗: 1 year
Mace
时间窗: 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.
NYHA functional classification
时间窗: 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.
left ventricular ejection fraction (LVEF)
时间窗: 1 year
BNP
时间窗: 1 year
B-type natriuretic peptide
left ventricular end-diastolic dimension (LVEDD)
时间窗: 1 year
interventricular septal thickness (IVS)
时间窗: 1 year
次要结局
未报告次要终点
研究者
Wenbin Lu
associate chief physician; Associate Professor
Zhongda Hospital