Observational Study That Will Evaluate Treatment Patterns in the Management of Hypertension in the Public Primary Care System (CLEAR-HTN)

September 2, 2026 updated by: AstraZeneca

Clinical Landscape of Epidemiology and Assessment of Results in Hypertension

This is a retrospective observational cohort study based on secondary use of routinely collected electronic health data. The design was selected to enable population-level characterisation of treatment patterns and clinical inertia (both diagnostic and therapeutic) in the management of hypertension across diverse settings in Brazil's public primary care system (SUS).

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is a retrospective observational cohort study based on secondary use of routinely collected electronic health data. The design was selected to enable population-level characterisation of treatment patterns and clinical inertia (both diagnostic and therapeutic) in the management of hypertension across diverse settings in Brazil's public primary care system (SUS).

The retrospective cohort design allows for efficient use of existing clinical data to evaluate real-world practice against national guideline recommendations. The primary outcomes relate to treatment decisions and delays rather than interventional effects; therefore, an observational design is methodologically appropriate and ethically preferable.

The study will be conducted across 05 Brazilian municipalities participating in the epHealth Primary Care Solutions platform. These municipalities span multiple regions and reflect heterogeneity in socio-demographic context, healthcare infrastructure, and epidemiological profiles.

Study Type

Observational

Enrollment (Estimated)

15000

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
      • Florianópolis, 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

Adults registered in the e-SUS PEC system who had encounters with primary healthcare services within the study period and had blood pressure measurements recorded. We will assess data from the entire population of approximately 05 muncipalities (comprising between 100.000 and 250.000 inhabitants). The municipalities will be seleceted from a pre-screened list of 20 cities located within all Brazilian regions.

Description

Inclusion Criteria:

  • Age ≥18 years at the time of Hypertension diagnosis
  • Hypertension diagnosis as retrieved from registered ICD codes or CIAP Codes (primary care codes) in the EMR , OR At least two blood pressure measurements ≥140/90 mmHg during the study period. The blood measurements should be consecutive and obtained within a 30 days period.
  • Continuous follow-up in the same municipality for at least 6 months after index measurement.
  • Availability of structured EMR data including clinical encounters, diagnoses, and prescriptions

Exclusion Criteria:

- Patients with incomplete data or not traceable in the registration systems

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
Uncontrolled blood pressure
Time Frame: through study completion, an average of 1 year
Proportion of patients with uncontrolled blood pressure (BP ≥ 140/90 mmHg) who did not receive treatment intensification within 3 months of a recorded elevated BP.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antihypertensive treatment
Time Frame: through study completion, an average of 1 year
Proportions receiving monotherapy vs. combination therapy; distribution by pharmacologic class.
through study completion, an average of 1 year
Risk stratification
Time Frame: through study completion, an average of 1 year
Likelihood of treatment escalation stratified by low/moderate vs. high/very high CV risk.
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: Julia Machline Carrion, Medical, EpHealth Soluções em Tecnologia da Informação Ltda

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 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D6970R00015

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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