Observational Study on the Prevalence and Risk Factors of Patients With Hyperkalaemia in Brazil

NCT07370194 | Recruiting

• 1 other identifier: D9480R00075
• Study Type: observational
• Target: 6,215
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperkalemia

Keywords

serum potassium levels

Outcome Measures

Primary Outcomes (2)

• Prevalence of Hyperkalemia

  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.

  through study completion, an average of 1 year

• Epidemiological and Clinical Characterisation

  Identify clinical, demographic, and therapeutic factors associated with serum potassium levels.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Practical and Social Impact

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consisted 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Curitiba, Brazil

RECRUITING

MeSH Terms

Conditions

Hyperkalemia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bernardo Montesanti de Almeida, Medical

  Hi Tecnologies

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 27, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

BR (1)