An interventional study of Automated Office Blood Pressure (AOBP) Standardized Measurement Protocol in Hypertension, Cardiovascular Diseases (CVD) and Vascular Diseases, sponsored by Menzies Institute for Medical Research. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Menzies Institute for Medical Research · Not applicable, Interventional, and Health services research
Among 93 studies in Hypertension with a site in Australia — 14 open to participants now, 18 under way, 7 of them phase 3. Hypertension · Australia.
Among the 93 studies in Hypertension with a site in Australia, this one is the 5th largest by planned enrollment of the 87 interventional ones, is one of 5 that started in 2026, is one of 30 with no phase, reaches primary completion later than 13 of the 17 other live ones, and was the 91st registered.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 6,000 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →14 of the 93 studies in Hypertension with a site in Australia are open now, in 12 countries. Each count lists the studies.
Of the 564 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (35%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →93 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 5 started in 2026.
Median enrollment 200 across the 87 interventional studies, 1,438 across the 5 observational. Of the 67 that completed or were terminated, 26 (39%) have results posted.
59 of 93 have an industry lead sponsor. The 10 most frequent:
Menzies Institute for Medical Research is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Menzies Institute for Medical Research has 1 study filed under Hypertension — fewer than ten, so there is no comparison to draw.
5 of the studies in Hypertension with a site in Australia that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03683186Phase 3United TherapeuticsA Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension | 2026-12 |
| NCT06059638Orchestra BioMed, IncBradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT | 2026-12 |
| NCT06935760The George InstituteOptimised Treatment for Hypertension Trial | 2026-12-30 |
| NCT06823115Indiana UniversityAssessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0 | 2027-01 |
| NCT07115953Medtronic VascularStreamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension | 2027-10-30 |
Among the 93 studies in Hypertension with a site in Australia, from their registry updates:
The goal of this clinical trial is to evaluate whether implementation of guideline-recommended Automated Office Blood Pressure (AOBP) measurement in Australian general practice clinics improves hypertension control among adults aged 18 years and older who are eligible for blood pressure assessment as part of routine clinical care. The study will also evaluate the implementation, sustainability, and health economic impact of AOBP in real-world primary care settings.
The main questions it aims to answer are:
Researchers will compare outcomes following implementation of AOBP with routinely collected clinical data from the period before implementation.
Participants will:
General practice staff will receive AOBP training, perform AOBP measurements, and participate in implementation evaluation activities.
Hypertension is the most common condition managed in general practice and remains one of the leading modifiable risk factors for cardiovascular disease (CVD). Accurate blood pressure (BP) measurement is fundamental to hypertension diagnosis and management; however, guideline-recommended clinic BP measurement procedures are often difficult to implement in routine practice because of time, staffing, and workflow constraints. General practitioners have reported that guideline-recommended BP measurement approaches are frequently impractical in routine clinical care, which may contribute to reduced confidence in clinic BP readings and therapeutic inertia.
Automated Office Blood Pressure (AOBP) measurement is a standardized approach to clinic BP assessment designed to reduce observer and procedural bias. The method incorporates an automated rest period followed by repeated automated measurements obtained while the patient remains seated, quiet, and undisturbed. AOBP values correlate closely with out-of-office BP measurement methods and, in 2025, AOBP was endorsed by Hypertension Australia and the National Hypertension Taskforce as the recommended standard for clinic BP measurement in Australia.
AOBP is typically performed by a trained staff member before the patient sees the general practitioner, in a quiet area outside the consultation room. This approach is intended to provide a more standardized BP assessment, reduce demands on consultation time, and support clinical decision-making through more reliable BP information while maintaining existing clinical care pathways and clinician responsibility for diagnosis, treatment, follow-up, and referral decisions.
Despite guideline endorsement and supporting evidence, AOBP has not been routinely implemented in Australian general practice. Barriers to implementation are predominantly structural rather than clinical and include limited access to validated equipment, staff training requirements, workflow integration challenges, and the absence of coordinated implementation support.
The study was informed by extensive co-design work involving general practitioners, practice staff, partner organisations, and community members. Previous pilot implementation work demonstrated that AOBP could be integrated into general practice workflows and was considered feasible, acceptable, and adaptable across diverse practice settings when supported by appropriate training, workflow integration, and governance arrangements. GPs participating in pilot implementation work reported increased trust in BP readings and greater confidence in hypertension management.
This study is a pragmatic, multisite, hybrid type 2 implementation-effectiveness trial using a non-randomised pre-post design. Approximately 40 Australian general practice clinics will participate in the study, with implementation occurring within each clinic over a 12-month period followed by a 6-month maintenance phase. The study has been designed to evaluate implementation of Automated Office Blood Pressure (AOBP) measurement within routine primary care settings and examine factors influencing implementation and sustainability in general practice.
The hybrid type 2 implementation-effectiveness design was selected to enable simultaneous evaluation of implementation and effectiveness under real-world conditions. Evaluation is guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework and the Practical, Robust Implementation and Sustainability Model (PRISM). RE-AIM provides the overarching framework for evaluation of effectiveness and implementation outcomes, while PRISM is used to identify barriers, enablers, contextual factors, adaptations, and determinants of implementation and sustainability.
In addition to implementation and effectiveness evaluations, the study will examine health economic considerations associated with implementation of AOBP in general practice and will explore longer-term health outcomes through approved linkage to routinely collected administrative and health datasets where available. These evaluations are intended to complement trial findings and inform future implementation, scale-up, and sustainability of AOBP in Australian primary care settings.
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.
Patients will be eligible to participate if they meet Australian guideline-recommended criteria for BP measurement, either for absolute CVD risk assessment or for BP assessment as an individual risk factor, and are attending a participating general practice clinic during the study period.
Eligible participants include:
Adults attending participating general practice clinics who are eligible for BP measurement for absolute CVD risk assessment, including:
Adults eligible for BP assessment as an individual risk factor, including:
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Automated Office Blood Pressure (AOBP) Standardized Measurement Protocol
Implementation of a standardized AOBP measurement protocol using a validated automated sphygmomanometer. AOBP measurements will be conducted by trained general practice staff. Patients will be seated in a quiet area with back supported, feet flat on the floor, arm supported at heart level, and an appropriately sized cuff applied. Following a 5-minute automated rest period, the device automatically records three seated blood pressure measurements at 30-second intervals and a fourth brief measurement to detect arrhythmia/atrial fibrillation. The device automatically calculates and records the average of the three seated measurements, heart rate, and arrhythmia status. Where clinically indicated, a standing protocol will be performed following the seated protocol and consists of two standing blood pressure measurements recorded at 30-second intervals after 1 minute of standing, followed by an arrhythmia assessment. Results are provided to the treating general practitioner.
The proportion of patients with treated and controlled hypertension, with the primary estimand being the absolute difference in this proportion between the pre-implementation period and 12-month AOBP implementation period.
Hypertension control will be defined according to Australian guideline recommendations using AOBP thresholds (average systolic BP \<135 mmHg and diastolic BP \<85 mmHg). "Treated" refers to patients receiving antihypertensive therapy.
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Average systolic and diastolic BP measured using AOBP
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Heart rate recording during AOBP measurement
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Frequency of repeat AOBP measures during the study period
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Changes in systolic and diastolic blood pressure values over time, measured using AOBP
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Clinician-measured BP values recorded in the electronic medical record, where available
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Initiation of antihypertensive therapy
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Intensification of antihypertensive therapy
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Changes in antihypertensive medication prescribing patterns
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Changes in cardiovascular medication prescribing patterns
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Proportion of participants receiving treatment for hypertension
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Documented referral for further assessment related to elevated BP (detected by AOBP device)
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Documented follow-up investigations related to elevated BP (detected by AOBP device [e.g. electrocardiogram monitoring, standard clinic blood pressure measurement, home BP monitoring, 24-hour ambulatory BP monitoring])
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Dates of clinic visits related to elevated BP (detected by AOBP device), where available
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Proportion of participants with possible arrhythmia (including AF) indicated by the AOBP device
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Documented referral for further assessment of possible arrhythmia (including AF) indicated by the AOBP device
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Dates of clinic visits related to possible arrhythmia (including AF) indicated by AOBP device, where available
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Completion of an absolute CVD risk calculation
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Documentation of patient characteristics relevant to cardiovascular risk (e.g. age, sex, smoking status, relevant CVD risk factors and pathology [i.e. cholesterol, glucose] and clinical conditions such as diabetes)
Time frame: Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.
Implementation outcomes will be evaluated within the overarching RE-AIM framework and will include measures of Reach, Adoption, Implementation and Maintenance.
These will examine participation and uptake of AOBP, fidelity, feasibility, acceptability, integration into routine practice, and sustained use during the maintenance period.
Time frame: Assessed throughout the 12-month AOBP implementation period, with Maintenance assessed at 18 months following the 6-month maintenance phase.
PRISM (Practical, Robust Implementation and Sustainability Model) will guide the implementation component by identifying anticipated and experienced barriers and enablers, and contextual factors influencing implementation and sustainability.
Time frame: Assessed throughout the 12-month AOBP implementation period, with Maintenance assessed at 18 months following the 6-month maintenance phase.
Costs associated with implementation of AOBP at the practice level, including equipment, staff training, workflow integration, and ongoing quality assurance
Time frame: Outcome assessed 12-months following AOBP implementation period.
Costs per patient correctly diagnosed and managed for hypertension using AOBP compared with usual care BP measurement
Time frame: Outcome assessed 12-months following AOBP implementation period.
Practice level and system level costs related to changes in clinical management, including antihypertensive prescribing and follow up
Time frame: Outcome assessed 12-months following AOBP implementation period.
Downstream health service utilisation and cost implications associated with CVD events, hospitalisations, and mortality (where data permit)
Time frame: Outcome assessed 12-months following AOBP implementation period.
Cardiovascular disease risk factors ascertained via data linkage
Obesity, hypertension, hyperlipidaemia, Type II diabetes mellitus, smoking status
Time frame: Exploratory outcome assessed 12-months following AOBP implementation period.
Death
CVD death, all-cause mortality
Time frame: Exploratory outcome assessed 12-months following AOBP implementation period.
Hospitalization ascertained via data linkage
Emergency department presentations, public hospital admissions, private hospital admissions
Time frame: Exploratory outcome assessed 12-months following AOBP implementation period.
Cardiovascular disease events ascertained via data linkage
Including: angina, acute myocardial infarction, ischemic heart disease, cardiomyopathy, atrial fibrillation, hypertensive heart disease, heart failure, heart valve disease, presence of cardiac and vascular implants and grafts, cerebrovascular disease, peripheral artery disease, chronic kidney disease
Time frame: Exploratory outcome assessed 12-months following AOBP implementation period.
Start is estimated for Oct 2026; primary completion for Oct 2029, 36 months later.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 36 months is above that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Menzies Institute for Medical Research