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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06935760




Registration number
NCT06935760
Ethics application status
Date submitted
13/04/2025
Date registered
20/04/2025

Titles & IDs
Public title
Optimised Treatment for Hypertension Trial
Scientific title
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
Secondary ID [1] 0 0
P01743
Universal Trial Number (UTN)
Trial acronym
OPTIMISE-BP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Fire and forget
Other interventions - Usual care with more intensive BP monitoring

Experimental: Fire and forget - 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.

Active comparator: Usual care with intensive BP monitoring - usual care prescribing by general practitioner enhanced with intensive blood pressure monitoring


Other interventions: 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 interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean difference in systolic blood pressure from baseline to 12 weeks
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Proportion achieving home SBP <130 mmHg (%) at 12 weeks
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Proportion achieving home BP control <135/85mmHg at 12 weeks
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Mean difference in change in home DBP from baseline to 12 week
Timepoint [3] 0 0
12 weeks

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The George Institute for Global Health - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nelson Wang, MD PhD
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nelson Wang, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 8052 4300
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06935760