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

May 26, 2026 updated by: AstraZeneca

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.

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

6215

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • Curitiba, Brazil
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Practical and Social Impact
Time Frame: through study completion, an average of 1 year
Expand knowledge about the clinical profile of patients with HK, supporting the development of screening, prevention, and early management strategies for a safer and more personalised approach.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Bernardo Montesanti de Almeida, Medical, Hi Tecnologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9480R00075

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal

Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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