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Hemodialysis or peritoneal dialysis CKD5 patients were randomly divided into Sacubitril/Valsartan and irbesartan treatment groups. Comparing the blood pressure, survival rates, the cardiac function, renal function,and adverse reactions of two groups, to evaluate whether the efficacy and safety of Sacubitril/Valsartan in the treatment of patients with CKD dialysis combined with heart failure is superior to that of irbesartan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacubitril/Valsartan | Experimental | The initial dose of 50mg Qd was increased to 50mg Bid after 1 week and maintained to 100mg Bid after 2 weeks if the patient could tolerate it |
|
| Irbesartan | Active Comparator | the maximum tolerated dose of irbesartan was administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacubitril/Valsartan | Drug | The initial dose of 50mg Qd was increased to 50mg Bid after 1 week and maintained to 100mg Bid after 2 weeks if the patient could tolerate it (no follow-up exit criteria were found). |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of ARNI on blood pressure in patients with CKD who are on dialysis | The evaluation indicator include office blood pressure | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of ARNI on ambulatory blood pressure | The evaluation indicator include ambulatory blood pressure | 1 year |
| The effect of ARNI on cardiac function in patients with CKD who are on dialysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nephrology, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University | Shanghai | Shanghai Municipality | China |
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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 |
| D000077405 | Irbesartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Irbesartan | Drug | The Initial dose of 75 mg Qd with sand, such as patients can tolerate and follow-up exit criteria (not appear, to 75 mg Bid to maintain after 1 week, 2 weeks can still be tolerance is raised to 150 mg Bid. |
|
|
The evaluation indicators include heart function-related indicators such as NT pro-BNP and EF value
| 1 year |
| The safety of ARNI in patients with CKD who are on dialysis | The evaluation indicators incidence of death (including death from cardiovascular events or other causes), hyperkalemia and other adverse events. | 1 year |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |