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CompletedNCT07370194HOPEUpdated Nov 2, 2026

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

An observational study in Hyperkalemia, sponsored by AstraZeneca. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by AstraZeneca · Observational

Updated Nov 2, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
6,434
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hyperkalemia

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Keywords

  • serum potassium levels
03

In context

Hyperkalemia

133 studies on the registry are indexed under Hyperkalemia; 25 are open to participants now.

This study's enrollment of 6,434 is above the median of 459 across 30 observational studies indexed under Hyperkalemia.

Browse Hyperkalemia studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Diagnosis of advanced malignant neoplasm undergoing palliative treatment; Other advanced diseases with a of less than one year; Patients with no information on risk factors for hyperkalaemia (HK).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
6,434 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: through study completion, an average of 1 year

  2. Epidemiological and Clinical Characterisation

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

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Practical and Social Impact

    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.

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • Research Site
    Curitiba, Brazil
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan

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.

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Nov 2, 2026
Primary completion
Sep 30, 2026→Aug 14, 2026 (actual)
Nov 2, 2026
Study completion
Sep 30, 2026→Aug 14, 2026 (actual)
Nov 2, 2026
Enrollment
6215 (estimated)→6434 (actual)
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Recruiting→Completed
    Primary completion Sep 30, 2026→Aug 14, 2026 (now actual)
    Study completion Sep 30, 2026→Aug 14, 2026 (now actual)
    Enrollment 6215 (estimated)→6434 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07370194
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jan 27, 2026
Start date
Mar 31, 2026
Primary completion
Aug 14, 2026
Completion
Aug 14, 2026
Last update
Nov 2, 2026

Study contacts

Bernardo Montesanti de Almeida, Medical
principal investigator · Hi Tecnologies

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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