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Optimised Treatment for Hypertension Trial

ConditionHypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe George Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fire and forget

    Other intervention

    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

  • Usual care with more intensive BP monitoring

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Fire and forgetExperimental treatment 1 intervention
Group B: Usual care with intensive BP monitoringActive comparator 1 intervention

Trial outcomes

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.

Time frame
12 weeks

Secondary outcomes

1

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

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

Time frame
12 weeks
2

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

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

Time frame
12 weeks
3

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

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

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The George Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: