Optimised Treatment for Hypertension 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 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:

1. determine which prescribing approach is more effective at lowering blood pressure after 12 weeks (end of study)
2. assess the safety, feasibility and acceptability of the two treatment approaches.

Conditions

• Hypertension

Interventions

OTHER

Fire and forget

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

OTHER

Usual care with more intensive BP monitoring

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.

Sponsors & Collaborators

• The George Institute

  lead OTHER

Principal Investigators

• Nelson Wang, MD PhD · The George Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-28

Primary Completion

2026-12-30

Completion

2026-12-30

Countries

• Australia

Study Locations