A Phase 4 interventional study of Sacubitril/Valsartan and Irbesartan in CKD5 Stage Dialysis and Heart Failure, sponsored by Ruijin Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-17.
Sponsored by Ruijin Hospital · Phase 4, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 330 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Sacubitril/Valsartan
the maximum tolerated dose of irbesartan was administered
Drug: Irbesartan
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).
Also known as: ARNI
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.
Also known as: ARB
The effect of ARNI on blood pressure in patients with CKD who are on dialysis
The evaluation indicator include office blood pressure
Time frame: 1 year
The effect of ARNI on ambulatory blood pressure
The evaluation indicator include ambulatory blood pressure
Time frame: 1 year
The effect of ARNI on cardiac function in patients with CKD who are on dialysis
The evaluation indicators include heart function-related indicators such as NT pro-BNP and EF value
Time frame: 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.
Time frame: 1 year
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Ruijin Hospital