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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Mean difference in systolic blood pressure from baseline to 12 weeks
研究概览
简要总结
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:
- determine which prescribing approach is more effective at lowering blood pressure after 12 weeks (end of study)
- assess the safety, feasibility and acceptability of the two treatment approaches.
详细描述
RATIONALE FOR TRIAL DESIGN:
Current pharmacological treatment of hypertension involves titration of treatment according to serial BP monitoring. However, BP is intrinsically variable and subject to significant measurement and random error that leads to a notoriously poor signal-to-noise ratio. Accordingly, measurement of BPs within 1 to 2 months of starting BP lowering treatment are not associated with true treatment response, adverse effects or cardiovascular risk reduction. Two contrasting solutions include 1) 'fire and forget' by prescribing BP lowering drugs empirically based on the desired average BP response observed from placebo controlled randomised trials without measuring repeat BP or 2) continue usual care with more intensive BP monitoring to try and improve the signal-to-noise ratio.
OBJECTIVES:
The primary aim is to compare the efficacy of remote empirical prescribing of BP lowering drugs informed by randomised trial data without routine BP monitoring ('fire and forget') versus usual care enhanced with intensive BP monitoring ('intensive BP monitoring').
The secondary aims are to determine if, compared to usual care with intensive BP monitoring, remote empirical treatment of high BP is acceptable to patients, is cost-effective and safe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Mean difference in systolic blood pressure from baseline to 12 weeks
时间窗: 12 weeks
Mean difference in change in home SBP from baseline to 12 weeks between the two treamtent groups.
次要结局
- 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)
- Proportion achieving home SBP <130 mmHg (%) at 12 weeks(12 weeks)