Optimised Treatment for Hypertension Trial

NCT06935760 | Not Yet Recruiting DMC

• 1 other identifier: P01743
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Proportion achieving home SBP <130 mmHg (%) at 12 weeks

  12 weeks

• Proportion achieving home BP control <135/85mmHg at 12 weeks

  12 weeks

• Mean difference in change in home DBP from baseline to 12 week

  12 weeks

Study Arms (2)

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.

Other: Fire and forget

Usual care with intensive BP monitoring

ACTIVE COMPARATOR

usual care prescribing by general practitioner enhanced with intensive blood pressure monitoring

Other: Usual care with more intensive BP monitoring

Interventions

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

Fire and forget

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.

Also known as: More BP measures

Usual care with intensive BP monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The George Institute: lead

Study Sites (1)

The George Institute for Global Health

Sydney, New South Wales, 2000, Australia

Location

MeSH Terms

Conditions

Hypertension

Interventions

Fires

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Environment; Environment and Public Health

Study Officials

• Nelson Wang, MD PhD

  The George Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nelson Wang, MD, PhD

CONTACT

+61 8052 4300; nwang@georgeinstitute.org.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm open-label decentralised pragmatic randomised controlled trial

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: April 20, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)