Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Mobility - Measured by Change in Gait Speed
研究概览
简要总结
This randomized clinical trial examines if lowering and maintaining 24-hour ambulatory systolic blood pressure to <130 mmHg (intensive control) versus <145 mmHg (standard control) slows/halts the progression of deterioration of mobility and cognitive function linked to white-matter disease (also known as white-matter hyperintensity or WMH) in patients with normal or mildly impaired mobility and cognition in subjects with detectable cerebrovascular disease (>0.5% WMH fraction of intracranial contents). The study patients will be enrolled and randomized to one of two levels of ambulatory blood pressure control (intensive to achieve a goal 24-hour systolic blood pressure of < 130 mmHg or standard to achieve a goal 24-hour systolic blood pressure of < 145 mmHg) for a total of 36 months.
详细描述
The study patients will be enrolled and randomized to one of two levels of ambulatory BP control (intensive to achieve a goal 24-hour systolic BP of < 130 mmHg or standard to achieve a goal 24-hour systolic BP of < 145 mmHg) for a total of 36 months. Similar antihypertensive regimens will be used in both of the treatment groups. Titration of antihypertensive therapies will be performed at monthly intervals for the first 3 to 6 months post-randomization to achieve goal systolic BP. The primary and secondary outcomes will be evaluated at baseline, and following 18 months and 36 months of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •75 years of age or older
- •Seated clinic systolic BP >150 mmHg in the untreated state (see criterion D)
- •At risk for cerebrovascular disease (history of smoking, dyslipidemia, type 2 diabetes, longstanding hypertension, family history). Patients must have visible (0.5% WMH or more)white-matter hypertensity lesions on screening magnetic resonance imaging
- •To achieve success in maintaining a 24-hour systolic BP of <140-145 mmHg in the standard treatment group or a systolic BP <125-130 mmHg in the intensive treatment group, patients will be eligible for inclusion if (1) their clinic systolic BP is 150-170 mmHg, and they are taking 0 to 2 antihypertensives, (2) their systolic BP is >170 mmHg and they are taking 0 to 1 antihypertensives
排除标准
- •Uncontrolled diabetes mellitus (HBA1c >10%)
- •History of stroke, dementia or clinically impaired gait (Mini-mental status exam score (MMSE) <24, Short Physical Performance Battery for gait (SPPB) < 9,)
- •Body Mass Index > 45 kg/m2 and/or arm circumference > 44 cm)
- •Poor kidney function (defined as estimated GFR <30 ml/minute)
- •Active liver disease or serum transaminases >3 times the upper limit of normal
- •Major cardiovascular event (e.g. myocardial infarction) or procedure (e.g. cardiac bypass surgery) in past 3 months; stroke with residual gait abnormality
- •Uncompensated congestive heart failure (NYHA class III or IV or documented ejection fraction <30%)
- •Chronic atrial fibrillation that disallows ambulatory BP monitoring to be successfully performed
- •Medical conditions that limit survival to < 3 years
- •Non-dermatologic cancer diagnosed within 2 years
- •Organ transplantation requiring anti-rejection drug therapy
- •Severe and unexplained weight loss (>15%) in past 6 months
- •Medical need to undergo recurrent phlebotomy or blood transfusions
- •Current participation in another investigational trial
- •Unable to obtain informed consent
- •Factors limiting adherence to the interventions
- •MRI contraindications (including MRI-incompatible implants, severe claustrophobia).
结局指标
主要结局
Mobility - Measured by Change in Gait Speed
时间窗: Change from baseline to 36 months
Change in gait speed (walking 8 meters) in seconds mediated by the accrual of white-matter hyperintensity lesions (WMH/intracranial cavity volume) using MRI and including degeneration of axonal and myelin components of white matter using MRI technology known as diffusion tensor imaging (DTI).
次要结局
- Cognitive Function - as Measured by Change in Stroop Test Score(Change from baseline to 36 months)
研究者
William B. White
Professor
UConn Health