Investigating the Impact of Serum Potassium Levels on Prevalence and Risk Factors Associated With Management Strategies for Patients With Hyperkalaemia in Brazilian Clinical Settings: An Observational Study.
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 6,215
- Locations
- 1
- Primary Endpoint
- Prevalence of Hyperkalemia
Overview
Brief Summary
This is a descriptive, retrospective study involving patients from private cardiology, nephrology, and dialysis clinics in Brazil who participated in the National Hyperkalaemia Diagnosis Campaign. The study used anonymised data from the Hi Technologies Ltda. database. The objective was to estimate and characterise the prevalence of hyperkalaemia (HK), as well as to analyse the demographic profile, clinical characteristics, risk factors and treatment patterns associated with total blood potassium levels.
Detailed Description
The aim of this study is to describe the clinical and demographic profile, as well as the prevalence of hyperkalaemia and its associated risk factors in patients who participated in the First National Campaign for the Diagnosis of Hyperkalaemia through the incorporation of a point-of-care device, with potassium results available during the consultation. The data used in this study consists of anonymised records. The study population will consist of adults aged 18 years or older, of both sexes, with a medical history of heart failure, diabetes mellitus, chronic kidney disease, and/or systemic arterial hypertension, who attended cardiology, nephrology, or dialysis clinics between April and November 2025.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants aged 18 years or older; Pre-existing comorbidities, including: o Heart failure (regardless of phenotype); o Chronic kidney disease (any stage); o Diabetes mellitus; o Systemic arterial hypertension.
Exclusion Criteria
- •Diagnosis of advanced malignant neoplasm undergoing palliative treatment; Other advanced diseases with a life expectancy of less than one year; Patients with no information on risk factors for hyperkalaemia (HK).
Outcomes
Primary Outcomes
Prevalence of Hyperkalemia
Time Frame: through study completion, an average of 1 year
To provide a comprehensive characterisation of the prevalence of hyperkalaemia in patients with high-risk comorbidities treated at private cardiology, nephrology, and dialysis clinics in Brazil.
Epidemiological and Clinical Characterisation
Time Frame: through study completion, an average of 1 year
Identify clinical, demographic, and therapeutic factors associated with serum potassium levels.
Secondary Outcomes
- Practical and Social Impact(through study completion, an average of 1 year)