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NCT06935760Not yet recruiting

Optimised Treatment for Hypertension Trial

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

Source: ClinicalTrials.gov · Last updated 21 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
120 (estimated)
First submitted
13 Apr 2025
Start date
28 Aug 2025
Primary completion date
30 Dec 2026
Lead sponsor
The George Institute
NCT number
NCT06935760

What you commit to

  • Study type: Interventional
  • Planned participants: 120
  • From 28 Aug 2025 to the primary completion date, 30 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 ≥150 mmHg for participants on one BP lowering drug
  • Home SBP ≥145 mmHg for participants on two BP lowering drugs
  • 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.

Lab values

  • Baseline eGFR \<45 ml/min/m2

Age

  • Of childbearing age and not using contraception.

Other

  • Home SBP ≥155 mmHg for untreated participants
  • Planned international travel for next 12 weeks

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The George Institute for Global Health
Coordinator of this site? Confirm its status
SydneyAustraliaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.