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The purpose of this study is to conduct a a cohort study to evaluate the efficacy and safety of the efficacy and safety of roxadustat for the treatment of anemia, quality of life and cardiac function in patients with heart failure and chronic kidney disease.
This is a cohort study in patients with anemia with heart failure complicated with chronic kidney disease, evaluating the the efficacy and safety of roxadustat. Patients were divided into roxadustat group and control group according to whether roxadustat was used or not. The efficacy and safety of roxadustat for the treatment of anemia, quality of life and cardiac function in patients with heart failure and chronic kidney disease will be evaluated.
The primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography, heart failure characteristics, diabetes status, kidney function, cardiac function, natriuretic peptide, dialysis, and additional co-morbidities, concomitant medications, and others.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roxadustat group | Experimental | Roxadustat group: patients with heart failure and chronic kidney disease and anemia treated with roxadustat and other anemia correction drugs. |
|
| Control group | Other | Control group: patients with heart failure and chronic kidney disease and anemia who were treated with other drugs include: Recombinant human eythropoietin (RH-EPO), iron agents (ferrous succinate, polysaccharide iron complex, iron sucrose, etc.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roxadustat | Drug | The initial dose of roxadustat was given according to body weight, which was more than 60kg: 100mg (three times a week); Weight less than 60kg: 70mg (three times a week); 2 weeks later, the corresponding indexes were rechecked and medication was adjusted according to hemoglobin. The target is hemoglobin 100-120g/L. Reference for medication Method: The use of roxadustat is the same as the RCT study of roxadustat in the treatment of anemia and the drug instructions of roxadustat published by N Engl J Med in 2019. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the hemoglobin from baseline | Hemoglobin is calculated by the routine blood test | up to 8 week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) | Change from baseline to week 12 in N-terminal pro-brain natriuretic peptide (NT-proBNP). Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication. | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Liver Injury | Liver injury is defined as: i) a rise of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to 3 times above the upper limit of normal [ULN], or ii) a rise of total bilirubin to 2 times above the upper limit of normal [ULN] | Up to 8 weeks |
| Hyperkalemia |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengxi Yang | Contact | +8615120049452 | mxtezuka@163.com | |
| Jiang Liu | Contact | +8619800361320 |
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|
| Recombinant human eythropoietin and/or Iron agents | Drug | Other drugs to treat anemia include: Recombinant human eythropoietin (RH-EPO), iron agents (ferrous succinate, polysaccharide iron complex, iron sucrose, etc.) |
|
| Change in Left Ventricular Systolic Function |
Change in left ventricular ejection fraction is assessed by two-dimensional directed M-mode echocardiography |
| Up to 24 weeks |
| Change in Left Ventricular End-Diastolic Diameter | Change in left ventricular end-diastolic diameter is assessed by two-dimensional directed M-mode echocardiography | Up to 24 weeks |
| Change in Left Ventricular Diastolic Function | Change in E/e' is assessed by two-dimensional directed M-mode echocardiography | Up to 24 weeks |
| Change in Low-density lipoprotein（LDL） | Change from baseline to week 8 in Low-density lipoprotein（LDL）.Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication. | Up to 8 weeks |
| Change in Serum ferritin | Change from baseline to week 8 in Serum ferritin.Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication. | Up to 8 weeks |
| Change in Transferrin saturation | Change from baseline to week 8 in Transferrin saturation.Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication. | Up to 8 weeks |
| Change in Left atrial volume | Change in left atrial volume is assessed by two-dimensional directed M-mode echocardiography | Up to 24 weeks |
| Change in Left atrial volume index | Change in left atrial volume index is assessed by two-dimensional directed M-mode echocardiography | Up to 24 weeks |
Hyperkalemia is defined as：Serum potassium > 5.5 mmol/L |
| Up to 8 weeks |
| Thromboembolism | Thromboembolism is defined as：Deep vein thrombosis at follow-up | Up to 1 year |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D051436 | Renal Insufficiency, Chronic |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C584543 | roxadustat |
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