Status:
NOT_YET_RECRUITING
Optimised Treatment for Hypertension Trial
Lead Sponsor:
The George Institute
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
August 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06935760
Start Date
August 28 2025
End Date
December 30 2026
Last Update
August 21 2025
Active Locations (1)
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1
The George Institute for Global Health
Sydney, New South Wales, Australia, 2000