HyperkalemiaHOPENCT07370194
Observational Study on the Prevalence and Risk Factors of Patients With Hyperkalaemia in Brazil
An observational study of Hyperkalemia, run by AstraZeneca at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperkalemia
- How many people
- 6,434 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Mar 2026to 14 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Hyperkalemia
- Keywords
- serum potassium levels
- Medical subject headings
- Hyperkalemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Epidemiological and Clinical Characterisation
Identify clinical, demographic, and therapeutic factors associated with serum potassium levels.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start31 Mar 2026
- Primary completion14 Aug 2026
- Study completion14 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,434 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernardo Montesanti de Almeida, Medical, Principal investigator, Hi Tecnologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370194
- Sponsor's protocol ID
- D9480R00075
- Acronym
- HOPE
- Status last verified
- Oct 2026
- First submitted
- 19 Jan 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07370194
- Acronym / sponsor ID
- HOPE / D9480R00075
- Conditions
- Hyperkalemia
- Keywords
- serum potassium levels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,434 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 14 Aug 2026 (actual)
- Study completion
- 14 Aug 2026 (actual)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Practical and Social Impact
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: 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.
Related trials for Hyperkalemia
Enrolling by invitationObservational study
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
RecruitingPhase 3
A Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
Hyperkalemia
Enrolling by invitationPhase 4
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
Chronic Kidney Disease, Type 2 Diabetes
Recruiting
Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
Hyperkalemia, Chronic Kidney Disease (Stages 4 and 5)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernardo Montesanti de Almeida, Medical principal investigator
Hi Tecnologies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperkalemia, run by AstraZeneca at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Hyperkalemia (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.