Hemodynamic Effects of Positive Airway Pressure to Treat Supine Hypertension and Improve Neurogenic Orthostatic Hypotension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Systolic blood pressure (overnight)
研究概览
简要总结
This study aims to learn about the effects of continuous positive airway pressure (CPAP) on people with autonomic failure and high blood pressure when lying down (supine hypertension) to determine if it can be used to treat their high blood pressure during the night. CPAP (a widely used treatment for sleep apnea) involves using a machine that blows air into a tube connected to a mask covering the nose, or nose and mouth, to apply a low air pressure in the airways.
The study includes 3-5 days spent in the Vanderbilt Clinical Research Center (CRC): at least one day of screening tests, followed by up to 3 study days. Subjects may be able to participate in daytime and/or overnight studies. The Daytime study consists of 2 study days: one with active CPAP and one with sham CPAP applied for up to 2 hours. The Overnight study consists of 3 study nights: one with active CPAP, one with sham CPAP, both applied for up to 9 hours and one night sleeping with the bed tilted head-up.
详细描述
The study includes up to 5 days spent in the Vanderbilt University Medical Center, at least one day of screening tests, followed by 2 study days and/or 2 study nights.
Screening tests include a physical examination and history, routine safety laboratory assessments, and autonomic nervous system testing. Medications for high blood pressure will be held for at least 5 half-lives before studies. Subjects may be able to participate in the daytime and/or the overnight studies.
Daytime Study:
Eligible participants will be studied on two separate days in random order: one day with a high CPAP level and one day with a low CPAP level. The active CPAP level will be determined during a CPAP titration trial
On each study day, participants will be instrumented to measure blood pressure, heart rate, hemodynamic parameters, segmental impedance, and markers of cardiovascular risk. A saline lock or IV catheter will be inserted in one of the arm's veins for blood sample collection. Urine will also be collected during studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
A sham CPAP will be used.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects, age 40-80 years, with autonomic failure including pure autonomic failure, multiple system atrophy and Parkinson disease.
- •Neurogenic orthostatic hypotension, defined as a ≥20-mmHg decrease in systolic blood pressure within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes.
- •Nocturnal supine hypertension (nighttime systolic blood pressure ≥140 mmHg) during the overnight screening for supine hypertension.
- •Patients who are willing and able to provide informed consent
排除标准
- •Patients with history of recent facial trauma or surgery or intolerance to CPAP or to the CPAP mask.
- •Patients who cannot tolerate the medication withdrawal, defined as those who are unable to stand for at least one minute or those with sustained supine blood pressure ≥180/110 mmHg after the medication withdrawal period.
- •Bedridden patients or those who are unable to stand due to motor impairment or severe orthostatic hypotension.
- •Smokers, patients who are pregnant, or have clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months; heart failure; and other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical or laboratory testing.
研究组 & 干预措施
Active CPAP (Daytime Study)
CPAP at 8, 10, or 12 cm H2O is applied for up to 2 hours while supine and awake.
干预措施: Active CPAP (Device)
Sham CPAP (Daytime Study)
Sham CPAP is applied for up to 2 hours while supine and awake.
干预措施: Sham CPAP (Device)
Active CPAP (Overnight Study)
CPAP at 8, 10, or 12 cm H2O is applied for up to 9 hours during the night.
干预措施: Active CPAP (Device)
Sham CPAP (Overnight Study)
Sham CPAP is applied for up to 9 hours during the night.
干预措施: Sham CPAP (Device)
Sleeping in a head-up tilt position (Overnight Study)
Sleeping with the bed tilted head-up by 10 degrees for up to 9 hours during the night.
干预措施: Sleeping in a head-up tilt (HUT) position (Other)
结局指标
主要结局
Systolic blood pressure (overnight)
时间窗: up to 9 hours during the intervention
Area under the curve of the change from baseline in systolic blood pressure
Systolic blood pressure (daytime)
时间窗: day 1 and 2 (within 2 hours of the intervention)
Change from baseline in systolic blood pressure at 2 hours of the intervention
次要结局
- Nocturnal diuresis (overnight)(up to 9 hours during the intervention)
- Stroke Volume (daytime)(day 1 and 2 (within 2 hours of the intervention))
- Morning orthostatic tolerance (overnight)(during 10 minutes upright tilt)
- Natriuretic hormone (daytime)(day 1 and 2 (within 2 hours of the intervention))
研究者
Italo Biaggioni
Professor of Medicine and Pharmacology
Vanderbilt University Medical Center