HypertensionOPTIMISE-BPNCT06935760
Optimised Treatment for Hypertension Trial
A study testing Fire and forget in people with Hypertension, run by The George Institute at 1 site in Australia.
Trial summary
This randomized trial compares two prescribing strategies to treat high blood pressure. One approach involves remote treatment informed by randomized trial evidence without regular monitoring of blood pressure ("fire and forget"), whilst the other involves usual care treatment with access to frequent blood pressure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Fire and forget
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Aug 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Written Informed consent
- Adult aged ≥18 years
- English proficiency
- High BP defined as home SBP ≥135 or DBP ≥85 mmHg, either untreated or receiving one or two BP lowering drugs
- Among untreated individuals, indicated for pharmacological treatment of high BP according to 2023 Australian Heart Foundation Cardiovascular Risk Management Guidelines
- Willing to receive BP lowering drug treatment remotely if treatment is indicated
Show all 9Show fewer
- Willing to check BP with home monitoring for 12 weeks
- Willing to participate in telehealth visit at baseline and 12 weeks
- Willing to undergo blood tests
Who cannot join
- Currently receiving three or more BP lowering drugs
- Currently receiving an antihypertensive that is not one of the five major antihypertensive drug classes
- Home SBP ≥155 mmHg for untreated participants
- Home SBP ≥150 mmHg for participants on one BP lowering drug
- Home SBP ≥145 mmHg for participants on two BP lowering drugs
- Baseline eGFR <45 ml/min/m2
Show all 10Show fewer
- Any abnormalities on baseline electrolytes that would prevent initiation of BP lowering therapy
- Participants with any other medical condition or taking any other concomitant medication which in the opinion of the investigator would make the participant unsuitable for the trial.
- Of childbearing age and not using contraception.
- Planned international travel for next 12 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
The George Institute for Global Health
Sydney, New South Wales, 2000
Nelson Wang, MD PhD, +61 8052 4300, nwang@georgeinstitute.org.au
Anthony Rodgers, PhD
About this study
Official title: Optimised Treatment for Hypertension Trial - A Feasibility and Pilot Trial of Fire and Forget Versus Usual Care With Intensive Blood Pressure Monitoring for Optimal Hypertension Care
This randomized trial compares two prescribing strategies to treat high blood pressure. One approach involves remote treatment informed by randomized trial evidence without regular monitoring of blood pressure ("fire and forget"), whilst the other involves usual care treatment with access to frequent blood pressure monitoring. The study will enrol participants with uncontrolled high blood pressure and randomize participants 1:1 to a "fire and forget" treatment group or a "more blood pressure monitoring" group for a total of 12 weeks. "Fire and forget" involves choosing the most appropriate treatment based on the highest quality evidence (randomized trial data), after which participants will stop measuring blood pressures until the end of study. The "more blood pressure monitoring" group will involve treatment as usual but with the access to frequent and high quality blood pressure monitoring.
The goal of this research is to:
- determine which prescribing approach is more effective at lowering blood pressure after 12 weeks (end of study)
- assess the safety, feasibility and acceptability of the two treatment approaches.
Read the detailed description
RATIONALE FOR TRIAL DESIGN:
Current pharmacological treatment of hypertension involves titration of treatment according to serial BP monitoring. However, BP is intrinsically variable and subject to significant measurement and random error that leads to a notoriously poor signal-to-noise ratio. Accordingly, measurement of BPs within 1 to 2 months of starting BP lowering treatment are not associated with true treatment response, adverse effects or cardiovascular risk reduction. Two contrasting solutions include 1) 'fire and forget' by prescribing BP lowering drugs empirically based on the desired average BP response observed from placebo controlled randomised trials without measuring repeat BP or 2) continue usual care with more intensive BP monitoring to try and improve the signal-to-noise ratio.
OBJECTIVES:
The primary aim is to compare the efficacy of remote empirical prescribing of BP lowering drugs informed by randomised trial data without routine BP monitoring ('fire and forget') versus usual care enhanced with intensive BP monitoring ('intensive BP monitoring').
The secondary aims are to determine if, compared to usual care with intensive BP monitoring, remote empirical treatment of high BP is acceptable to patients, is cost-effective and safe.
PARTICIPANT ELIGIBILITY:
Key Inclusion Criteria:
- Adult aged ≥18 years
- High BP defined as home SBP ≥135 or DBP ≥85 mmHg, either untreated or receiving one or two BP lowering drugs
- Among untreated individuals, indicated for pharmacological treatment of high BP according to 2023 NHF Cardiovascular Risk Management Guidelines
Key Exclusion Criteria:
- Currently receiving three or more BP lowering drugs
- Home SBP ≥155 mmHg for untreated participants
- Home SBP ≥150 mmHg for participants on one BP lowering drug
- Home SBP ≥145 mmHg for participants on two BP lowering drugs
- Baseline eGFR <45 ml/min/m2
- Any abnormalities on baseline electrolytes that would prevent initiation of BP lowering therapy
- Participants with any other medical condition or taking any other concomitant medication which in the opinion of the investigator would make the participant unsuitable for the trial
TRIAL INTERVENTION \& RANDOMISATION:
All participants who meet the eligibility criteria for the trial will be randomised (1:1) to:
Fire and forget: Remote evidence informed empirical prescribing of BP lowering therapy without serial BP monitoring. Regimen chosen based on the average BP reduction and lowest risk of adverse effects observed in placebo controlled randomised trials Intensive BP monitoring: usual care as per GP prescribing enhanced with intensive BP monitoring
TRIAL OUTCOMES:
Primary: Mean difference in change in home SBP from baseline to 12 weeks
Secondary:
- Efficacy: Proportion achieving home BP control <135/85 mmHg, difference in change in systolic DBP from baseline to 12 weeks
- Safety: Incidence of adverse events leading to treatment withdrawal, adverse events of special interest such as symptoms of hypotension, and SAEs from baseline to 12 weeks.
- Acceptability: interviews of participants
- Self-reported medication adherence
- Cost-effectiveness: Average total cost per patient achieving BP control
- Conditions
- Hypertension
- Being tested
- Fire and forget, Usual care with more intensive BP monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fire and forgetOther
Evidence informed prescription of BP lowering drugs based on the average observed blood pressure (BP) reduction and risk of treatment discontinuation due to adverse effects in double-blind placebo-controlled randomised clinical trials. Clinicians will prescribe BP treatment regimen using generic, established BP lowering medications that will be expected to achieve at least 80% of future systolic BP values under 130 mmHg. Treatment will be delivered remotely through telehealth consultation. Participants will be asked to avoid routine BP measurements after treatment is commenced to avoid misleading chance fluctuations in BP before 12 weeks. Adverse events will be monitored remotely, and treatments can be adjusted according to adverse events but not according to BP measurements
Usual care with more intensive BP monitoringOther
Also called More BP measures
Participants will follow-up with their usual general practitioner, who will treat participants BP according to local practice guidelines. General practitioners will have access to the same BP lowering medications as the "fire and forget" treatment group. Participants will continue to monitor their BP throughout the 12 week period through home BP monitoring with optional 24 hour ambulatory BP monitoring. Participants will maintain a BP diary and present their BP results to their treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Fire and forget | Experimental | Evidence informed empirical prescribing of blood pressure (BP) lowering therapy without serial BP monitoring. Regimen chosen based on the average BP reduction and lowest risk of adverse effects observed in placebo controlled randomised trials. No further blood pressure measurements after baseline until end of study at 12 weeks. Receives: Other: Fire and forget |
| Usual care with intensive BP monitoring | Active comparator | usual care prescribing by general practitioner enhanced with intensive blood pressure monitoring Receives: Other: Usual care with more intensive BP monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in systolic blood pressure from baseline to 12 weeks
Mean difference in change in home SBP from baseline to 12 weeks between the two treamtent groups.
Measured: 12 weeks
Secondary outcomes (3)
Proportion achieving home SBP <130 mmHg (%) at 12 weeks
Proportion achieving home SBP <130 mmHg (%) at 12 weeks
Measured: 12 weeks
Proportion achieving home BP control <135/85mmHg at 12 weeks
Proportion achieving home BP control <135/85mmHg at 12 weeks
Measured: 12 weeks
Mean difference in change in home DBP from baseline to 12 week
Mean difference in change in home DBP from baseline to 12 week
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start28 Aug 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm open-label decentralised pragmatic randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelson Wang, MD PhD, Principal investigator, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935760
- Sponsor's protocol ID
- P01743
- Acronym
- OPTIMISE-BP
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimised Treatment for Hypertension Trial - A Feasibility and Pilot Trial of Fire and Forget Versus Usual Care With Intensive Blood Pressure Monitoring for Optimal Hypertension Care
- ClinicalTrials.gov ID
- NCT06935760
- Acronym / sponsor ID
- OPTIMISE-BP / P01743
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Study start
- 28 Aug 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Apr 2025 (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 randomized trial compares two prescribing strategies to treat high blood pressure. One approach involves remote treatment informed by randomized trial evidence without regular monitoring of blood pressure ("fire and forget"), whilst the other involves usual care treatment with access to frequent blood pressure monitoring. The study will enrol participants with uncontrolled high blood pressure and randomize participants 1:1 to a "fire and forget" treatment group or a "more blood pressure monitoring" group for a total of 12 weeks. "Fire and forget" involves choosing the most appropriate treatment based on the highest quality evidence (randomized trial data), after which participants will stop measuring blood pressures until the end of study. The "more blood pressure monitoring" group will involve treatment as usual but with the access to frequent and high quality blood pressure monitoring.
The goal of this research is to:
- determine which prescribing approach is more effective at lowering blood pressure after 12 weeks (end of study)
- assess the safety, feasibility and acceptability of the two treatment approaches.
Detailed description
RATIONALE FOR TRIAL DESIGN:
Current pharmacological treatment of hypertension involves titration of treatment according to serial BP monitoring. However, BP is intrinsically variable and subject to significant measurement and random error that leads to a notoriously poor signal-to-noise ratio. Accordingly, measurement of BPs within 1 to 2 months of starting BP lowering treatment are not associated with true treatment response, adverse effects or cardiovascular risk reduction. Two contrasting solutions include 1) 'fire and forget' by prescribing BP lowering drugs empirically based on the desired average BP response observed from placebo controlled randomised trials without measuring repeat BP or 2) continue usual care with more intensive BP monitoring to try and improve the signal-to-noise ratio.
OBJECTIVES:
The primary aim is to compare the efficacy of remote empirical prescribing of BP lowering drugs informed by randomised trial data without routine BP monitoring ('fire and forget') versus usual care enhanced with intensive BP monitoring ('intensive BP monitoring').
The secondary aims are to determine if, compared to usual care with intensive BP monitoring, remote empirical treatment of high BP is acceptable to patients, is cost-effective and safe.
PARTICIPANT ELIGIBILITY:
Key Inclusion Criteria:
- Adult aged ≥18 years
- High BP defined as home SBP ≥135 or DBP ≥85 mmHg, either untreated or receiving one or two BP lowering drugs
- Among untreated individuals, indicated for pharmacological treatment of high BP according to 2023 NHF Cardiovascular Risk Management Guidelines
Key Exclusion Criteria:
- Currently receiving three or more BP lowering drugs
- Home SBP ≥155 mmHg for untreated participants
- Home SBP ≥150 mmHg for participants on one BP lowering drug
- Home SBP ≥145 mmHg for participants on two BP lowering drugs
- Baseline eGFR <45 ml/min/m2
- Any abnormalities on baseline electrolytes that would prevent initiation of BP lowering therapy
- Participants with any other medical condition or taking any other concomitant medication which in the opinion of the investigator would make the participant unsuitable for the trial
TRIAL INTERVENTION \& RANDOMISATION:
All participants who meet the eligibility criteria for the trial will be randomised (1:1) to:
Fire and forget: Remote evidence informed empirical prescribing of BP lowering therapy without serial BP monitoring. Regimen chosen based on the average BP reduction and lowest risk of adverse effects observed in placebo controlled randomised trials Intensive BP monitoring: usual care as per GP prescribing enhanced with intensive BP monitoring
TRIAL OUTCOMES:
Primary: Mean difference in change in home SBP from baseline to 12 weeks
Secondary:
- Efficacy: Proportion achieving home BP control <135/85 mmHg, difference in change in systolic DBP from baseline to 12 weeks
- Safety: Incidence of adverse events leading to treatment withdrawal, adverse events of special interest such as symptoms of hypotension, and SAEs from baseline to 12 weeks.
- Acceptability: interviews of participants
- Self-reported medication adherence
- Cost-effectiveness: Average total cost per patient achieving BP control
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm open-label decentralised pragmatic randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Fire and forget | Experimental | Other: Fire and forgetEvidence informed empirical prescribing of blood pressure (BP) lowering therapy without serial BP monitoring. Regimen chosen based on the average BP reduction and lowest risk of adverse effects observed in placebo controlled randomised trials. No further blood pressure measurements after baseline until end of study at 12 weeks. |
| Usual care with intensive BP monitoring | Active comparator | Other: Usual care with more intensive BP monitoringusual care prescribing by general practitioner enhanced with intensive blood pressure monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written Informed consent
- Adult aged ≥18 years
- English proficiency
- High BP defined as home SBP ≥135 or DBP ≥85 mmHg, either untreated or receiving one or two BP lowering drugs
- Among untreated individuals, indicated for pharmacological treatment of high BP according to 2023 Australian Heart Foundation Cardiovascular Risk Management Guidelines
Key exclusion criteria (10 listed)
- Currently receiving three or more BP lowering drugs
- Currently receiving an antihypertensive that is not one of the five major antihypertensive drug classes
- Home SBP ≥155 mmHg for untreated participants
- Home SBP ≥150 mmHg for participants on one BP lowering drug
- Home SBP ≥145 mmHg for participants on two BP lowering drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fire and forgetEvidence informed prescription of BP lowering drugs based on the average observed blood pressure (BP) reduction and risk of treatment discontinuation due to adverse effects in double-blind placebo-controlled randomised clinical trials. Clinicians will prescribe BP treatment regimen using generic, established BP lowering medications that will be expected to achieve at least 80% of future systolic BP values under 130 mmHg. Treatment will be delivered remotely through telehealth consultation. Participants will be asked to avoid routine BP measurements after treatment is commenced to avoid misleading chance fluctuations in BP before 12 weeks. Adverse events will be monitored remotely, and treatments can be adjusted according to adverse events but not according to BP measurements | Other | Fire and forget |
| Usual care with more intensive BP monitoringAlso: More BP measuresParticipants will follow-up with their usual general practitioner, who will treat participants BP according to local practice guidelines. General practitioners will have access to the same BP lowering medications as the "fire and forget" treatment group. Participants will continue to monitor their BP throughout the 12 week period through home BP monitoring with optional 24 hour ambulatory BP monitoring. Participants will maintain a BP diary and present their BP results to their treating physician. | Other | Usual care with intensive BP monitoring |
Primary outcome
Mean difference in systolic blood pressure from baseline to 12 weeks
Time frame: 12 weeks
Mean difference in change in home SBP from baseline to 12 weeks between the two treamtent groups.
3 secondary outcomes
Proportion achieving home SBP <130 mmHg (%) at 12 weeks
Time frame: 12 weeks
Proportion achieving home BP control <135/85mmHg at 12 weeks
Time frame: 12 weeks
Mean difference in change in home DBP from baseline to 12 week
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Nelson Wang, MD PhD principal investigator
The George Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fire and forget in people with Hypertension, run by The George Institute at 1 site in Australia.
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 9 inclusion and 10 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: opening soon, as of the sponsor's last update on 21 Aug 2025. 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 Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nelson Wang, MD, PhD (+61 8052 4300, nwang@georgeinstitute.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference in systolic blood pressure from baseline to 12 weeks (time frame: 12 weeks). 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 21 Aug 2025.