Treatment of Orthostatic Intolerance
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Increase in heart rate with standing
研究概览
简要总结
This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.
详细描述
This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.
Pilot drug trials are 4h in duration from ~9am -1pm. Different short-acting medications will be used to determine their acute hemodynamic effects in patients with orthostatic intolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- 是
入选标准
- •Chronic symptoms (> 6 months) with standing upright
排除标准
- •Obvious cause of hypovolemia or drugs that could worsen tachycardia
- •Chronic severe medical conditions such as cancer or ischemic heart disease
研究组 & 干预措施
4
Clonidine
干预措施: Clonidine (Drug)
1
Acetazolamide
干预措施: Acetazolamide (Drug)
2
Atomoxetine
干预措施: Atomoxetine (Drug)
2
Atomoxetine
干预措施: Atomoxetine & Propranolol (Drug)
3
NO Drug
干预措施: NO Drug (Other)
5
Entacapone
干预措施: Entacapone (Drug)
5
Entacapone
干预措施: Entacapone & Propranolol (Drug)
6
Indomethacin
干预措施: Indomethacin (Drug)
7
Isosorbide Dinitrate
干预措施: Isosorbide Dinitrate (Drug)
8
Mecamylamine
干预措施: Mecamylamine (Drug)
9
Memantine
干预措施: memantine (Drug)
10
Melatonin
干预措施: Melatonin (Dietary Supplement)
11
Midodrine
干预措施: Midodrine (Drug)
12
Modafinil
干预措施: Modafinil (Drug)
12
Modafinil
干预措施: Modafinil & Propranolol (Drug)
13
Octreotide
干预措施: Octreotide (Drug)
14
Placebo (lactose tablet)
干预措施: Placebo (Radiation)
15
Propranolol
干预措施: Entacapone & Propranolol (Drug)
15
Propranolol
干预措施: Atomoxetine & Propranolol (Drug)
15
Propranolol
干预措施: Propranolol (Drug)
15
Propranolol
干预措施: Modafinil & Propranolol (Drug)
16
Sertraline
干预措施: Sertraline (Drug)
17
Normal Saline (0.9%) 1 liter
干预措施: IV Saline (Procedure)
18
Drinking Water
干预措施: Drinking Water (Other)
19
Dead Space Breathing Device
干预措施: Breathing Device (Device)
Abdominal Binder
Abdominal binder with inflatable pressure over abdomen
干预措施: Abdominal binder (Device)
结局指标
主要结局
Increase in heart rate with standing
时间窗: 1-4 hours
次要结局
- Sitting heart rate(1-4 hours)
- Decrease in blood pressure with standing(1-4 hours)
- Blood pressure(1-4 hours)
- Orthostatic symptoms score(Baseline, 2h, 4h)
- Standing heart rate(1-4 hours)
研究者
Satish R. Raj
Assistant Professor of Medicine & Pharmacology
Vanderbilt University