Treatment of Hypotensive Patients Having a Unique Pattern of Autonomic Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in Systolic Blood Pressure With Standing
研究概览
简要总结
The purpose of this study is to try different medications in patients with low blood pressure and other problems with their involuntary (autonomic) nervous system. The pharmacological trials in this study will perhaps lead to more effective treatment. The protocol includes single dose trials, dose-selection trials, 5-day trials and chronic (approximately 2 months) trials, although only dose-selection trials were consistently performed and have results presented.
详细描述
We see many patients at the Autonomic Dysfunction Center who can be given a fairly definitive diagnosis, e.g., Orthostatic Intolerance, Pure Autonomic Failure, Multiple System Atrophy, and Baroreflex Failure. However, some patients present with a unique constellation of symptoms of autonomic dysfunction so that they do not fit into a diagnostic category. We hypothesize that a genetic cause exists in some of these patients. We further propose that our comprehensive evaluation of these patients will provide us with information on the pathophysiology of their condition and assist us in optimizing their treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with severe orthostatic hypotension and other autonomic symptoms who do not meet criteria for one of our standard diagnoses
- •non-smokers
- •drug-free
- •able to give informed consent
- •free of pulmonary, renal, hematopoietic, hepatic and cardiac disease
排除标准
- •medications affecting the autonomic nervous system
- •any chronic illness (cardiac, pulmonary, endocrine, gastrointestinal, rheumatologic)
- •anemia (Hct < 30)
- •women of childbearing age who are pregnant or nursing
研究组 & 干预措施
Droxidopa
Patients with known or suspected Dopamine beta-Hydroxylase Deficiency were administered Droxidopa doses of 25 mg, 50 mg, 100 mg, 200 mg, 250 mg or 300 mg up to three times daily. Supine and upright blood pressures were subsequently measured 60 to 240 minutes post-dose.
干预措施: Droxidopa Oral Product (Drug)
结局指标
主要结局
Change in Systolic Blood Pressure With Standing
时间窗: Up to 240 minutes post dose on Study Days 1, 2, 3 and 4.
The difference between upright and supine systolic blood pressures (dSBP; upright - supine) was calculated for each patient at 60-240 minutes after each dose of droxidopa. For each post-dose timepoint and study day, the average of up to three blood pressure readings per droxidopa dose was calculated. Dosing is individualized for each patient based upon how well the drug is tolerated and the degree of improvement in orthostatic vital signs and symptoms following drug administration. The dosages administered, as well as the number of timepoints and days, therefore, varied between patients.
次要结局
未报告次要终点
研究者
Emily M. Garland
Research Associate Professor
Vanderbilt University