Retrospective multicenter clinical study of the frequency of hyperkalemia in severely renally impaired patients treated with sacubitril valsartan

JRCT ID: jRCT1040230154

Registered date:16/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: heart failure
• Date of first enrollment: 29/02/2024
• Study type: Observational

Outcome(s)

Primary Outcome

Incidence of the following composite endpoints in the groups of normal renal function, mildly impaired renal function, moderately impaired renal function, severely impaired renal function, and dialysis patients
1) Incidence of serum potassium level grater than 5.5 mmom/L, 2) reduction or discontinuation of SV, reduction or discontinuation of MRA, or initiation or increase of new potassium-binding agents when serum potassium level is above the upper limit of normal

Secondary Outcome

1) Incidence of serum potassium level grater than 5.5 mmol/L in each groups of normal renal function, mildly impaired renal function, moderately impaired renal function, severely impaired renal function and dialysis patients
2) The incidence of serum potassium level grater than 5.5 mmol/L with and without concomitant medications

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Include criteria: Inpatients prescribed SV for heart failure

Exclude criteria

Patients with malignant comorbidities or diagnosed with malignancy during the SV observation period
Patients with a history of SV prescription within 4 weeks prior to the date of first SV prescription
Inpatients who are prescribed SV for doses other than twice daily

Related Information

• Primary Sponsor: Watanabe Kozo
• Source(s) of Monetary Support: The Mt.Fuji Foundation for Healthcare Innovation and Cluster Development