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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:
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:
Key Exclusion Criteria:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual care with intensive BP monitoring | Active Comparator | usual care prescribing by general practitioner enhanced with intensive blood pressure monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fire and forget | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion achieving home SBP <130 mmHg (%) at 12 weeks | Proportion achieving home SBP <130 mmHg (%) at 12 weeks | 12 weeks |
| Proportion achieving home BP control <135/85mmHg at 12 weeks | Proportion achieving home BP control <135/85mmHg at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nelson Wang, MD, PhD | Contact | +61 8052 4300 | nwang@georgeinstitute.org.au |
| Name | Affiliation | Role |
|---|---|---|
| Nelson Wang, MD PhD | The George Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The George Institute for Global Health | Sydney | New South Wales | 2000 | Australia |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005390 | Fires |
| ID | Term |
|---|---|
| D004777 | Environment |
| D004778 | Environment and Public Health |
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Two-arm open-label decentralised pragmatic randomised controlled trial
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| Usual care with more intensive BP monitoring | Other | 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. |
|
|
| 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 | 12 weeks |