ISRCTN18030225进行中（未招募）4 期
Optimising Prescription of Treatment In older patients with Mild hypertension at Increased risk of Serious adverse Events (OPTIMISE2)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,014
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Willing and able to give informed consent for participation in the trial (or with Personal Legal Representative consent)
- •2.Willing and able to report any safety concerns or with a suitable carer able to report these if unable
- •3.Registered at either a practice using electronic health record systems (e.g. EMIS or SystmOne) or contributing to or willing to contribute to ORCHID
- •4.Aged 75 years or above at recruitment.
- •5.Controlled systolic blood pressure, defined (in accordance with NICE 2019 guidelines) as less than 140 mmHg (if aged 75-79 years) or less than 150 mmHg (if aged 80 years or above). Systolic blood pressure level will be based on screening measurements taken at baseline (mean of the 2nd and 3rd readings taken in a standardised manner) or from patient records.
- •6.Prescribed two or more antihypertensive medications for at least 12 months prior to trial entry. Antihypertensive medications defined as any ACE inhibitor, angiotensin II receptor blocker, calcium channel blocker, thiazide and thiazide-like diuretic (including loop diuretics), potassium-sparing diuretic, alpha-blocker, beta-blocker, vasodilator antihypertensives, centrally acting antihypertensives, direct renin inhibitors, adrenergic neurone blocking drugs.
- •7.Stable dose of antihypertensive medications for at least four weeks prior to trial entry.
- •8.Moderate or severe frailty (defined by an eFI score =0.20) and/or high risk (>5%) of hypotension, syncope or falls in the next 5 years, based on STRATIFY risk prediction algorithms applied to an individual’s electronic health record.
排除标准
- •1. Heart failure due to left ventricular systolic dysfunction (LVSD) prescribed only ACE inhibitors/angiotensin II receptor blockers and/or beta-blockers and/or spironolactone (removing any of which would be contraindicated).
- •2. Heart failure diagnosis without a coded echocardiogram (might have undiagnosed LVSD and a compelling need for ACEI/ angiotensin II receptor blocker and beta-blockers).
- •3. Suffered a myocardial infarction or stroke within the past 6 months.
- •4. Secondary hypertension or previous accelerated or malignant hypertension.
- •5. Lacking capacity to give consent and without a consultee present at the point of screening.
- •6. Participating in any other randomised controlled trial of drug treatment or interventional medical devices in the past 4 weeks (can be re-invited subsequently).
研究者
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