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This paper will mainly present the renal results from a clinical study aimed to observe the effect of sacubitril/valsartan in advanced chronic kedney disease patients with heart failure.All patients will receive LCZ696.The results will be compared before and after treatment.
On trial entry, patients will first receive LCZ696 50mg twice daily.According to the condition of disease and tolerance,the dose will be doubled every 2 weeks until the target maintenance dose 200mg twice daily is reached unless potassium or change in kidney function preclude a dose increase(reduction in dose will be permitted if the larger dose will not be tolerated, and temporary interruption will be permitted at any time if required for clinical reasons).The trial will be followed up for 12 weeks. Study visits will be scheduled at 2,4,6,8,10and12 weeks (and additional visits will be arranged where necessary to monitor participant safety).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCZ696 treatment | Experimental | LCZ696 200mg twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCZ 696 | Drug | LCZ696 200mg twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in estimated glomerular filtration rate(eGFR) | Blood samples will be collected for analysis of glomerular filtration rate(eGFR) every 2weeks . | 12 weeks |
| Change in urinary microalbumin/creatinine ratio(uACR) | Urine samples will be collected for analysis of urinary microalbumin/creatinine ratio(uACR) every 2weeks. | 12 weeks |
| Concentration of N terminal pro B type natriuretic peptide(NT-prpBNP) | Blood samples will be collected for analysis of concentration of N terminal pro B type natriuretic peptide(NT-proBNP) every 2weeks. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| blood uric acid | Blood samples will be collected for analysis of uric acid every 2weeks. | 12 weeks |
| Rate of HbA1c | Blood samples will be collected for analysis of HbA1c every 2weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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Clinical Study Report (CSR)
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
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| 12weeks |
| Systolic and diastolic blood pressure | Systolic and diastolic blood pressure will be measured every 2weeks. | 12 weeks |
| left ventricle eject fraction | Cardiac ultrasound will be measured every 2weeks. | 12 weeks |
| Concentration of postassium | Blood samples will be collected for analysis of concentration of postassium every 2weeks. | 12 weeks |
| Concentration of serum troponin | Blood samples will be collected for analysis of concentration of serum troponin every 2weeks. | 12 weeks |
| Concentration of alanine aminotransferase or aspartate aminotransferase | Blood samples will be collected for analysis of concentration of alanine aminotransferase or aspartate aminotransferase every 2weeks. | 12 weeks |
| Concentration of sodio | Urine samples will be collected for analysis of concentration of sodion every 2weeks. | 12 weeks |