Sympathetic Regulation of Large Artery Stiffness in Humans With Age-Related Isolated Systolic Hypertension
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in carotid-femoral pulse wave velocity
研究概览
简要总结
Stiffening of your blood vessels, particularly the large vessels from your heart (called the aorta and carotids) you age contributes to the development of cardiovascular disease (CVD) such as heart attack and stroke. Nerve activity from your brain to your body also increases with advancing age but it is unknown if this nerve activity contributes directly to the stiffening on your blood vessels in older adults in addition to high blood pressure. Therefore, successful completion of the proposed aims will have a significant clinical impact by identifying if nerve activity from your brain could be a novel target for therapies that would lower stiffness of the aorta and carotid arteries in older adults.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 60-85
- •non-smoking
- •clinically healthy
- •untreated or treated stage 1 isolated systolic hypertension (ISH) (systolic BP 130-139 mmHg; diastolic BP <90 mmHg) or stage 2 ISH (systolic BP 140-159 mmHg; diastolic BP <90 mmHg) per 2017 AHA/ACC hypertension guidelines
- •if subject is on antihypertensive medications, they will stop taking medication for a one-week washout period after Visit 1 before they return for Visit
- •They will come in at day 3 and day 7 of the one-week washout for a BP reading, to confirm that systolic BP is <160 mmHg.
排除标准
- •no history of cardiovascular disease (e.g., myocardial infarction, bypass surgery, angioplasty/stent, heart failure, cardiomyopathy, pacemaker/defibrillator, peripheral artery disease), pulmonary disease, liver disease, Type I or II diabetes, cancer (treated by chemotherapy and/or radiation), psychiatric illness, on aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
- •aspirin, NSAIDs, vitamins, herbal supplements, omega-3-fatty acids will have to discontinue for at least 1 week before participation and remain discontinued during the study.
- •blood thinners, serotonin reuptake inhibitors (SSRIs), or PDE5 inhibitors will also be excluded.
- •Women must be postmenopausal for at least 6 months (surgical or natural) and not currently on hormone replacement therapy.
- •Subjects not on antihypertensive will not be eligible if their resting clinic systolic BP is <130 mmHg or >160 mmHg and diastolic BP >90 mmHg.
研究组 & 干预措施
Clonidine
0.2 mg/day oral
干预措施: Clonidine (Drug)
Hydrochlorothiazide
37.5 mg/day oral
干预措施: Hydrochlorothiazide (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in carotid-femoral pulse wave velocity
时间窗: Baseline and after 4 weeks
Aortic stiffness
次要结局
- Change in carotid flow pulsatility index(Baseline and after 4 weeks)
- Change in carotid distensibility index(Baseline and after 4 weeks)
- Change in carotid intimal medial thickness (IMT)(Baseline and after 4 weeks)
研究者
Gary L. Pierce, PhD
Associate Professor
University of Iowa