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临床试验/NCT03312556
NCT03312556招募中不适用

Treatment of Supine Hypertension in Autonomic Failure With Continuous Positive Airway Pressure

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年9月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
12
试验地点
1
主要终点
Supine Systolic Blood Pressure

研究概览

简要总结

Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe and complicates the treatment of orthostatic hypotension. The purpose of this study is to assess whether continuous positive airway pressure (CPAP) decreases blood pressure in autonomic failure patients with supine hypertension.

详细描述

Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined.

This study will test the hypothesis that continuous positive airway pressure (CPAP) has an acute lowering-BP effect in autonomic failure patients with supine hypertension. CPAP is a widely-used treatment for sleep-related breathing disorders including sleep apnea, that uses mild air pressure to keep the breathing airways open. It involves using a CPAP machine that blows air into a tube connected to a mask placed over the nose, or nose and mouth. For these studies, a commercial CPAP device will be used to apply pressure sequentially at 0, 4, 8, 12 and 16 cm H2O for 1-20 minute each. Depending on the BP response and tolerability to CPAP, CPAP may be applied during the night using a CPAP level that was tolerable and showed a BP-lowering effect during the acute test.

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
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with autonomic failure and with supine hypertension from all races

排除标准

  • All medical students
  • Pregnant women
  • High-risk patients (e.g. heart failure, symptomatic coronary artery disease, liver impairment, history of stroke or myocardial infarction)
  • History of serious allergies or asthma.

研究组 & 干预措施

Placebo pill or patch or sham CPAP

Placebo Comparator

Placebo pill or patch or sham CPAP

干预措施: Placebo (Drug)

CPAP (continuous positive airway pressure)

Active Comparator

Continuous positive airway pressure during the night

干预措施: continuous positive airway pressure (CPAP) (Device)

结局指标

主要结局

Supine Systolic Blood Pressure

时间窗: 12 hours

change in supine systolic blood pressure from baseline

次要结局

  • Urinary volume(12 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Italo Biaggioni

Professor of Medicine and Pharmacology

Vanderbilt University Medical Center

研究点 (1)

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